| Primary | Scale for the Assessment of Negative Symptoms (SANS) Total Score | Mean SANS Total Score by Treatment and Week. SANS total score range = 0-85. Higher scores indicate more severe negative symptoms. | Of the 56 participants exposed to study drug, 3 withdrew before any efficacy data was collected, leaving 53 for whom at least some interim efficacy data was collected. Participants had to complete at least two weeks follow-up to be included in the symptom analysis. | Posted | | Mean | Standard Deviation | units on a scale | | Every other week for 6 weeks | | | | ID | Title | Description |
|---|
| OG000 | 1: Oxytocin/Placebo-galantamine | Subjects randomized to oxytocin will receive oxytocin and placebo-galantamine | | OG001 | 2: Galantamine/Placebo-oxytocin | Subjects randomized to galantamine will receive galantamine and placebo-oxytocin | | OG002 | 3: Placebo-galantamine /Placebo-oxytocin | Subjects randomized to placebo will receive placebo-galantamine and placebo-oxytocin |
| | | Title | Denominators | Categories |
|---|
| Treatment Week 0 | - ParticipantsOG00015
- ParticipantsOG00119
- ParticipantsOG00219
| |
| |
| Primary | Mean Z-Scores for Composite Cognitive Primary Outcome* by Treatment Group and Week | * Composite Cognitive Primary Outcome = mean of z-scores from the Brief Assessment of Cognition in Schizophrenia (BACS) Symbol Digit test, the Hopkins Verbal Learning Test (HVLT), and the Rapid Visual Information Processing test (RVIP). Z-scores for each test were calculated as Z = (individual patient score - pooled baseline mean)/(pooled baseline standard deviation). Higher values of the composite score represent a better outcome. | Five subjects were unable to handle the demands of the Rapid Visual Information Processing (RVIP) test, part of the composite primary outcome measure, and did not provide valid data. | Posted | | Mean | Standard Deviation | units on a scale | | Treatment Week 0 and Week 6 | | | | ID | Title | Description |
|---|
| OG000 | 1: Oxytocin/Placebo-galantamine | Subjects randomized to oxytocin will receive oxytocin and placebo-galantamine | | OG001 | 2: Galantamine/Placebo-oxytocin | Subjects randomized to galantamine will receive galantamine and placebo-oxytocin | | OG002 | 3: Placebo-galantamine /Placebo-oxytocin | Subjects randomized to placebo will receive placebo-galantamine and placebo-oxytocin |
|
| Secondary | Scale for the Assessment of Negative Symptoms (SANS) - Avolition | Mean score by treatment and week. Scores range from 0-5, with higher scores indicating a worse outcome. | Of the 56 participants exposed to study drug, 3 withdrew before any efficacy data was collected, leaving 53 for whom at least some interim efficacy data was collected. Participants had to complete at least two weeks follow-up to be included in the symptom analysis. | Posted | | Mean | Standard Deviation | units on a scale | | Every other week for 6 weeks | | | | ID | Title | Description |
|---|
| OG000 | 1: Oxytocin/Placebo-galantamine | Subjects randomized to oxytocin will receive oxytocin and placebo-galantamine | | OG001 | 2: Galantamine/Placebo-oxytocin | Subjects randomized to galantamine will receive galantamine and placebo-oxytocin | | OG002 | 3: Placebo-galantamine /Placebo-oxytocin | Subjects randomized to placebo will receive placebo-galantamine and placebo-oxytocin |
| |
| Secondary | Scale for the Assessment of Negative Symptoms (SANS) - Anhedonia | Mean score by treatment and week. Scores range from 0-5, with higher scores indicating a worse outcome. | Of the 56 participants exposed to study drug, 3 withdrew before any efficacy data was collected, leaving 53 for whom at least some interim efficacy data was collected. Participants had to complete at least two weeks follow-up to be included in the symptom analysis. | Posted | | Mean | Standard Deviation | units on a scale | | Every other week for 6 weeks | | | | ID | Title | Description |
|---|
| OG000 | 1: Oxytocin/Placebo-galantamine | Subjects randomized to oxytocin will receive oxytocin and placebo-galantamine | | OG001 | 2: Galantamine/Placebo-oxytocin | Subjects randomized to galantamine will receive galantamine and placebo-oxytocin | | OG002 | 3: Placebo-galantamine /Placebo-oxytocin | Subjects randomized to placebo will receive placebo-galantamine and placebo-oxytocin |
| |
| Secondary | Scale for the Assessment of Negative Symptoms (SANS) - Alogia | Mean score by treatment and week. Scores range from 0-5, with higher scores indicating a worse outcome. | Of the 56 participants exposed to study drug, 3 withdrew before any efficacy data was collected, leaving 53 for whom at least some interim efficacy data was collected. Participants had to complete at least two weeks follow-up to be included in the symptom analysis. | Posted | | Mean | Standard Deviation | units on a scale | | Every other week for 6 weeks | | | | ID | Title | Description |
|---|
| OG000 | 1: Oxytocin/Placebo-galantamine | Subjects randomized to oxytocin will receive oxytocin and placebo-galantamine | | OG001 | 2: Galantamine/Placebo-oxytocin | Subjects randomized to galantamine will receive galantamine and placebo-oxytocin | | OG002 | 3: Placebo-galantamine /Placebo-oxytocin | Subjects randomized to placebo will receive placebo-galantamine and placebo-oxytocin |
| |
| Secondary | Scale for the Assessment of Negative Symptoms (SANS) - Blunted Affect | Mean score by treatment and week. Scores range from 0-5, with higher scores indicating a worse outcome. | Of the 56 participants exposed to study drug, 3 withdrew before any efficacy data was collected, leaving 53 for whom at least some interim efficacy data was collected. Participants had to complete at least two weeks follow-up to be included in the symptom analysis. | Posted | | Mean | Standard Deviation | units on a scale | | Every other week for 6 weeks | | | | ID | Title | Description |
|---|
| OG000 | 1: Oxytocin/Placebo-galantamine | Subjects randomized to oxytocin will receive oxytocin and placebo-galantamine | | OG001 | 2: Galantamine/Placebo-oxytocin | Subjects randomized to galantamine will receive galantamine and placebo-oxytocin | | OG002 | 3: Placebo-galantamine /Placebo-oxytocin | Subjects randomized to placebo will receive placebo-galantamine and placebo-oxytocin |
| |
| Secondary | Brief Psychiatric Rating Scale (BPRS) - Total Score | The total BPRS score is calculated by adding the scores for scales #1-#18. Each scale ranges from "1=Not Present" to "7=Very Severe". Total scores range from a minimum score of 18 to a maximum score of 126. A higher total score indicates a more severe psychiatric symptom rating. | Safety data available for 56 participants exposed to study treatment. | Posted | | Mean | Standard Deviation | units on a scale | | Every other week for 6 weeks | | | | ID | Title | Description |
|---|
| OG000 | 1: Oxytocin/Placebo-galantamine | Subjects randomized to oxytocin will receive oxytocin and placebo-galantamine | | OG001 | 2: Galantamine/Placebo-oxytocin | Subjects randomized to galantamine will receive galantamine and placebo-oxytocin | | OG002 | 3: Placebo-galantamine /Placebo-oxytocin | Subjects randomized to placebo will receive placebo-galantamine and placebo-oxytocin |
| |
| Secondary | Brief Psychiatric Rating Scale (BPRS) - Psychosis Score | The psychosis score is calculated by adding the scores for scales #4 Conceptual Disorganization, #11 Suspiciousness, #12 Hallucinatory Behavior, and #15 Unusual Thought Content. Each scale ranges from "1=Not Present" to "7=Very Severe". The minimum psychosis score is 4 and the maximum psychosis score is 28. A higher score indicates a more severe psychosis rating. | Safety data available for the 56 participants exposed to study treatment. | Posted | | Mean | Standard Deviation | units on a scale | | Every other week for 6 weeks | | | | ID | Title | Description |
|---|
| OG000 | 1: Oxytocin | Oxytocin: 24 IU oxytocin or placebo in a total of 6 puffs (3 puffs per nostril)daily for 6 weeks | | OG001 | 2: Galantamine | Galantamine or placebo Galantamine: Galantamine will be dispensed as follows: 4 mg bid x 7 days; 8mg bid x 7days, then 12 mg bid for the last 4 weeks. | | OG002 | 3: Placebo | Placebo: placebo-Galantamine 1 capsules twice a day and placebo-oxytocin 3 puffs in each nostril once a day. |
| |
| Secondary | Calgary Depression Scale (CDS) - Total Score | Total score calculated by adding scores for scales #1-#9. Each scale ranges from "0=Absent" to "3=Severe". The minimum total CDS score is 0 and the maximum total CDS score is 27. A higher score indicates a more severe depression rating. | Of the 56 participants exposed to study drug, 3 withdrew before any efficacy data was collected, leaving 53 for whom at least some interim efficacy data was collected. Participants had to complete at least two weeks follow-up to be included in the symptom analysis. | Posted | | Mean | Standard Deviation | units on a scale | | Every other week for 6 weeks | | | | ID | Title | Description |
|---|
| OG000 | 1: Oxytocin/Placebo-galantamine | Subjects randomized to oxytocin will receive oxytocin and placebo-galantamine | | OG001 | 2: Galantamine/Placebo-oxytocin | Subjects randomized to galantamine will receive galantamine and placebo-oxytocin | | OG002 | 3: Placebo-galantamine /Placebo-oxytocin | Subjects randomized to placebo will receive placebo-galantamine and placebo-oxytocin |
| |
| Secondary | Arizona Sexual Experience Questionnaire (ASEX) Female | Mean ASEX total scores by treatment and week for female participants. Total scores are calculated by adding scores for scales #1-#5. Each scale ranges from "1=Easily/Extremely" to "6=Never/None". The minimum total ASEX score is 5 and the maximum score is 30. Lower scores indicate more positive sexual experiences. | Female participants who completed at least two weeks follow-up. | Posted | | Mean | Standard Deviation | units on a scale | | Once during evaluation and once at the end of 6 weeks of study treatment | | | | ID | Title | Description |
|---|
| OG000 | 1: Oxytocin/Placebo-galantamine | Subjects randomized to oxytocin will receive oxytocin and placebo-galantamine | | OG001 | 2: Galantamine/Placebo-oxytocin | Subjects randomized to galantamine will receive galantamine and placebo-oxytocin | | OG002 | 3: Placebo-galantamine /Placebo-oxytocin | Subjects randomized to placebo will receive placebo-galantamine and placebo-oxytocin |
| |
| Secondary | Arizona Sexual Experience Questionnaire (ASEX) Male | Mean ASEX total scores by treatment and week for male participants. Total scores are calculated by adding scores for scales #1-#5. Total scores are calculated by adding scores for scales #1-#5. Each scale ranges from "1=Easily/Extremely" to "6=Never/None". The minimum total ASEX score is 5 and the maximum score is 30. Lower scores indicate more positive sexual experiences. | Male participants who completed at least two weeks follow-up. | Posted | | Mean | Standard Deviation | units on a scale | | Once during evaluation and once at the end of 6 weeks of study treatment | | | | ID | Title | Description |
|---|
| OG000 | 1: Oxytocin/Placebo-galantamine | Subjects randomized to oxytocin will receive oxytocin and placebo-galantamine | | OG001 | 2: Galantamine/Placebo-oxytocin | Subjects randomized to galantamine will receive galantamine and placebo-oxytocin | | OG002 | 3: Placebo-galantamine /Placebo-oxytocin | Subjects randomized to placebo will receive placebo-galantamine and placebo-oxytocin |
| |
| Secondary | Vital Signs - Diastolic Blood Pressure | Mean diastolic blood pressure by treatment and follow-up week | Safety data for 56 participants exposed to study treatment. | Posted | | Mean | Standard Deviation | mm-Hg | | Weekly for 6 weeks | | | | ID | Title | Description |
|---|
| OG000 | 1: Oxytocin/Placebo-galantamine | Subjects randomized to oxytocin will receive oxytocin and placebo-galantamine | | OG001 | 2: Galantamine/Placebo-oxytocin | Subjects randomized to galantamine will receive galantamine and placebo-oxytocin | | OG002 | 3: Placebo-galantamine /Placebo-oxytocin | Subjects randomized to placebo will receive placebo-galantamine and placebo-oxytocin |
| |
| Secondary | Vital Signs - Systolic Blood Pressure | Mean systolic blood pressure by treatment and follow-up week | Safety data for 56 participants exposed to study treatment. | Posted | | Mean | Standard Deviation | mm-Hg | | Weekly for 6 weeks | | | | ID | Title | Description |
|---|
| OG000 | 1: Oxytocin/Placebo-galantamine | Subjects randomized to oxytocin will receive oxytocin and placebo-galantamine | | OG001 | 2: Galantamine/Placebo-oxytocin | Subjects randomized to galantamine will receive galantamine and placebo-oxytocin | | OG002 | 3: Placebo-galantamine /Placebo-oxytocin | Subjects randomized to placebo will receive placebo-galantamine and placebo-oxytocin |
| |
| Secondary | Vital Signs - Weight | Mean weight (kg) by treatment and follow-up week | Safety data for 56 participants exposed to study treatment. | Posted | | Mean | Standard Deviation | kg | | Weekly for 6 weeks | | | | ID | Title | Description |
|---|
| OG000 | 1: Oxytocin/Placebo-galantamine | Subjects randomized to oxytocin will receive oxytocin and placebo-galantamine | | OG001 | 2: Galantamine/Placebo-oxytocin | Subjects randomized to galantamine will receive galantamine and placebo-oxytocin | | OG002 | 3: Placebo-galantamine /Placebo-oxytocin | Subjects randomized to placebo will receive placebo-galantamine and placebo-oxytocin |
| |
| Secondary | Vital Signs - Pulse | Mean sitting pulse (bpm) by treatment and follow-up week | Safety data for 56 participants exposed to study treatment. | Posted | | Mean | Standard Deviation | bpm | | Weekly for 6 weeks | | | | ID | Title | Description |
|---|
| OG000 | 1: Oxytocin/Placebo-galantamine | Subjects randomized to oxytocin will receive oxytocin and placebo-galantamine | | OG001 | 2: Galantamine/Placebo-oxytocin | Subjects randomized to galantamine will receive galantamine and placebo-oxytocin | | OG002 | 3: Placebo-galantamine /Placebo-oxytocin | Subjects randomized to placebo will receive placebo-galantamine and placebo-oxytocin |
| |
| Secondary | Simpson-Angus Scale (SAS) | SAS total score for extrapyramidal side effects: Frequencies of greatest within-participant increase (worsening) from pre-treatment baseline, by treatment group. Total scores calculated by adding scores from scales #1-#11. Each scale ranges from "0=None/Normal" to "4=Extreme/Severe". The minimum total score is 0 and the maximum score is 44. Higher scores indicate a more severe extrapyramidal side effect rating. | Of the 56 participants exposed to study drug, 3 withdrew before any efficacy data was collected, leaving 53 for whom at least some interim efficacy data was collected. Participants had to complete at least two weeks follow-up to be included in the symptom analysis. | Posted | | Number | | percentage of participants | | Baseline, week 3, and week 6 | | | | ID | Title | Description |
|---|
| OG000 | 1: Oxytocin/Placebo-galantamine | Subjects randomized to oxytocin will receive oxytocin and placebo-galantamine | | OG001 | 2: Galantamine/Placebo-oxytocin | Subjects randomized to galantamine will receive galantamine and placebo-oxytocin | | OG002 | 3: Placebo-galantamine /Placebo-oxytocin | Subjects randomized to placebo will receive placebo-galantamine and placebo-oxytocin |
|
| Secondary | Abnormal Involuntary Movement Scale (AIMS) | AIMS Total Score: Frequencies of Maximum Within- Participant Increases (worsening) from Baseline by Treatment Group. Total score calculated by adding scores from scales #1-#10. Each scale ranges from "0=None" to "4=Severe". The minimum total AIMS score is 0 and the maximum score is 40. Higher scores indicate a more severe abnormal involuntary movement rating. | 50 participants who completed the trial. | Posted | | Number | | percentage of participants | | Treatment Week 0 and Week 6 | | | | ID | Title | Description |
|---|
| OG000 | 1: Oxytocin/Placebo-galantamine | Subjects randomized to oxytocin will receive oxytocin and placebo-galantamine | | OG001 | 2: Galantamine/Placebo-oxytocin | Subjects randomized to galantamine will receive galantamine and placebo-oxytocin | | OG002 | 3: Placebo-galantamine /Placebo-oxytocin | Subjects randomized to placebo will receive placebo-galantamine and placebo-oxytocin |
| |
| Secondary | Electrocardiogram (EKG) | Mean corrected QT interval (QTc) by study week and treatment. | 50 participants who completed the trial. | Posted | | Mean | Standard Deviation | QTc | | Once during Evaluation and once at Treatment Week 6 | | | | ID | Title | Description |
|---|
| OG000 | 1: Oxytocin/Placebo-galantamine | Subjects randomized to oxytocin will receive oxytocin and placebo-galantamine | | OG001 | 2: Galantamine/Placebo-oxytocin | Subjects randomized to galantamine will receive galantamine and placebo-oxytocin | | OG002 | 3: Placebo-galantamine /Placebo-oxytocin | Subjects randomized to placebo will receive placebo-galantamine and placebo-oxytocin |
| |
| Secondary | Barnes Akathisia Scale (BAS) - Global Score | For each subject, the largest increase from baseline in the global akathisia score at any visit during follow-up was calculated. The global akathisia score ranges from "0=Absent" to "5=Severe Akathisia". Higher scores indicate a more severe global rating of akathisia. | 50 participants who completed the trial. | Posted | | Number | | percentage of participants | | Treatment Week 0 and Week 6 | | | | ID | Title | Description |
|---|
| OG000 | 1: Oxytocin/Placebo-galantamine | Subjects randomized to oxytocin will receive oxytocin and placebo-galantamine | | OG001 | 2: Galantamine/Placebo-oxytocin | Subjects randomized to galantamine will receive galantamine and placebo-oxytocin | | OG002 | 3: Placebo-galantamine /Placebo-oxytocin | Subjects randomized to placebo will receive placebo-galantamine and placebo-oxytocin |
| |
| Secondary | Blood Oxytocin Levels | Blood Oxytocin Levels by Treatment and Visit | Of the 56 participants exposed to study drug, 3 withdrew before any efficacy data was collected, leaving 53 for whom at least some interim efficacy data was collected. | Posted | | Mean | Standard Deviation | pg/mL | | Treatment Week 0 and Week 6 | | | | ID | Title | Description |
|---|
| OG000 | 1: Oxytocin/Placebo-galantamine | Subjects randomized to oxytocin will receive oxytocin and placebo-galantamine | | OG001 | 2: Galantamine/Placebo-oxytocin | Subjects randomized to galantamine will receive galantamine and placebo-oxytocin | | OG002 | 3: Placebo-galantamine /Placebo-oxytocin | Subjects randomized to placebo will receive placebo-galantamine and placebo-oxytocin. |
| |
| Secondary | Laboratory Measures - ALT/SGPT | Alanine transaminase/serum glutamic-pyruvic transaminase (ALT/SGPT) blood levels by treatment group and visit. | Available participant lab data at Evaluation and Week 6. | Posted | | Mean | Standard Deviation | U/L | | Once during evaluation and once at the end of 6 weeks of study treatment | | | | ID | Title | Description |
|---|
| OG000 | 1: Oxytocin/Placebo-galantamine | Subjects randomized to oxytocin will receive oxytocin and placebo-galantamine | | OG001 | 2: Galantamine/Placebo-oxytocin | Subjects randomized to galantamine will receive galantamine and placebo-oxytocin | | OG002 | 3: Placebo-galantamine /Placebo-oxytocin | Subjects randomized to placebo will receive placebo-galantamine and placebo-oxytocin |
| |
| Secondary | Laboratory Measures - AST/SGOT | Aspartate aminotransferase/serum glutamic oxaloacetic transaminase (AST/SGOT) blood levels by treatment group and visit. | Available participant lab data at Evaluation and Week 6. | Posted | | Mean | Standard Deviation | U/L | | Once during evaluation and once at the end of 6 weeks of study treatment | | | | ID | Title | Description |
|---|
| OG000 | 1: Oxytocin/Placebo-galantamine | Subjects randomized to oxytocin will receive oxytocin and placebo-galantamine | | OG001 | 2: Galantamine/Placebo-oxytocin | Subjects randomized to galantamine will receive galantamine and placebo-oxytocin | | OG002 | 3: Placebo-galantamine /Placebo-oxytocin | Subjects randomized to placebo will receive placebo-galantamine and placebo-oxytocin |
| |
| Secondary | Laboratory Measures - Alkaline Phosphatase | Alkaline phosphatase blood level by treatment group and visit. | Available participant lab data at Evaluation at Week 6. | Posted | | Mean | Standard Deviation | U/L | | Once during evaluation and once at the end of 6 weeks of study treatment | | | | ID | Title | Description |
|---|
| OG000 | 1: Oxytocin/Placebo-galantamine | Subjects randomized to oxytocin will receive oxytocin and placebo-galantamine | | OG001 | 2: Galantamine/Placebo-oxytocin | Subjects randomized to galantamine will receive galantamine and placebo-oxytocin | | OG002 | 3: Placebo-galantamine /Placebo-oxytocin | Subjects randomized to placebo will receive placebo-galantamine and placebo-oxytocin |
| |
| Secondary | Laboratory Measures - Calcium | Calcium blood levels by treatment group and visit. | Available participant lab data at Evaluation and Week 6. | Posted | | Mean | Standard Deviation | mg/dL | | Once during evaluation and once at the end of 6 weeks of study treatment | | | | ID | Title | Description |
|---|
| OG000 | 1: Oxytocin | Subjects randomized to oxytocin will receive oxytocin and placebo-galantamine | | OG001 | 2: Galantamine | Subjects randomized to galantamine will receive galantamine and placebo-oxytocin | | OG002 | 3: Placebo | Subjects randomized to placebo will receive placebo-galantamine and placebo-oxytocin |
| |
| Secondary | Laboratory Measures - Sodium | Sodium blood levels by treatment group and visit. | Available participant lab data at Evaluation and Week 6. | Posted | | Mean | Standard Deviation | mE/qL | | Once during evaluation and once at the end of 6 weeks of study treatment | | | | ID | Title | Description |
|---|
| OG000 | 1: Oxytocin | Subjects randomized to oxytocin will receive oxytocin and placebo-galantamine | | OG001 | 2: Galantamine | Subjects randomized to galantamine will receive galantamine and placebo-oxytocin | | OG002 | 3: Placebo | Subjects randomized to placebo will receive placebo-galantamine and placebo-oxytocin |
| |
| Secondary | Laboratory Measures - Potassium | Potassium blood levels by treatment group and visit. | Available participant lab data at Evaluation and Week 6. | Posted | | Mean | Standard Deviation | mE/qL | | Once during evaluation and once at the end of 6 weeks of study treatment | | | | ID | Title | Description |
|---|
| OG000 | 1: Oxytocin | Subjects randomized to oxytocin will receive oxytocin and placebo-galantamine | | OG001 | 2: Galantamine | Subjects randomized to galantamine will receive galantamine and placebo-oxytocin | | OG002 | 3: Placebo | Subjects randomized to placebo will receive placebo-galantamine and placebo-oxytocin |
| |
| Secondary | Laboratory Measures - Chloride | Chloride blood levels by treatment group and visit. | Available participant lab data for Evaluation and Week 6. | Posted | | Mean | Standard Deviation | mE/qL | | Once during evaluation and once at the end of 6 weeks of study treatment | | | | ID | Title | Description |
|---|
| OG000 | 1: Oxytocin | Subjects randomized to oxytocin will receive oxytocin and placebo-galantamine | | OG001 | 2: Galantamine | Subjects randomized to galantamine will receive galantamine and placebo-oxytocin | | OG002 | 3: Placebo | Subjects randomized to placebo will receive placebo-galantamine and placebo-oxytocin |
| |
| Secondary | Laboratory Measures - CO2 | Carbon Dioxide (CO2) blood levels by treatment group and visit. | Available participant lab data for Evaluation and Week 6. | Posted | | Mean | Standard Deviation | mE/qL | | Once during evaluation and once at the end of 6 weeks of study treatment | | | | ID | Title | Description |
|---|
| OG000 | 1: Oxytocin | Subjects randomized to oxytocin will receive oxytocin and placebo-galantamine | | OG001 | 2: Galantamine | Subjects randomized to galantamine will receive galantamine and placebo-oxytocin | | OG002 | 3: Placebo | Subjects randomized to placebo will receive placebo-galantamine and placebo-oxytocin |
| |
| Secondary | Laboratory Measures - Cholesterol | Total cholesterol blood levels by treatment group and visit. | Available participant lab data for Evaluation and Week 6. | Posted | | Mean | Standard Deviation | mg/dL | | Once during evaluation and once at the end of 6 weeks of study treatment | | | | ID | Title | Description |
|---|
| OG000 | 1: Oxytocin | Subjects randomized to oxytocin will receive oxytocin and placebo-galantamine | | OG001 | 2: Galantamine | Subjects randomized to galantamine will receive galantamine and placebo-oxytocin | | OG002 | 3: Placebo | Subjects randomized to placebo will receive placebo-galantamine and placebo-oxytocin |
| |
| Secondary | Laboratory Measures - HDL | High-density lipoprotein (HDL) blood levels by treatment group and visit. | Available participant data from Evaluation and Week 6. | Posted | | Mean | Standard Deviation | mg/dL | | Once during evaluation and once at the end of 6 weeks of study treatment | | | | ID | Title | Description |
|---|
| OG000 | 1: Oxytocin | Subjects randomized to oxytocin will receive oxytocin and placebo-galantamine | | OG001 | 2: Galantamine | Subjects randomized to galantamine will receive galantamine and placebo-oxytocin | | OG002 | 3: Placebo | Subjects randomized to placebo will receive placebo-galantamine and placebo-oxytocin |
| |
| Secondary | Laboratory Measures - LDL | Low-density lipoprotein (LDL) blood levels by treatment group and visit. | Available participant lab data for Evaluation and Week 6. | Posted | | Mean | Standard Deviation | mg/dL | | Once during evaluation and once at the end of 6 weeks of study treatment | | | | ID | Title | Description |
|---|
| OG000 | 1: Oxytocin | Subjects randomized to oxytocin will receive oxytocin and placebo-galantamine | | OG001 | 2: Galantamine | Subjects randomized to galantamine will receive galantamine and placebo-oxytocin | | OG002 | 3: Placebo | Subjects randomized to placebo will receive placebo-galantamine and placebo-oxytocin |
| |
| Secondary | Laboratory Measures - Triglycerides | Triglyceride blood levels by treatment group and visit. | Available participant lab data for Evaluation and Week 6. | Posted | | Mean | Standard Deviation | mg/dL | | Once during evaluation and once at the end of 6 weeks of study treatment | | | | ID | Title | Description |
|---|
| OG000 | 1: Oxytocin | Subjects randomized to oxytocin will receive oxytocin and placebo-galantamine | | OG001 | 2: Galantamine | Subjects randomized to galantamine will receive galantamine and placebo-oxytocin | | OG002 | 3: Placebo | Subjects randomized to placebo will receive placebo-galantamine and placebo-oxytocin |
| |
| Secondary | Laboratory Measures - VLDL | Very low density lipoprotein (VLDL) blood levels by treatment group and visit. | Available participant lab data for Evaluation and Week 6. | Posted | | Mean | Standard Deviation | mg/dL | | Once during evaluation and once at the end of 6 weeks of study treatment | | | | ID | Title | Description |
|---|
| OG000 | 1: Oxytocin | Subjects randomized to oxytocin will receive oxytocin and placebo-galantamine | | OG001 | 2: Galantamine | Subjects randomized to galantamine will receive galantamine and placebo-oxytocin | | OG002 | 3: Placebo | Subjects randomized to placebo will receive placebo-galantamine and placebo-oxytocin |
| |
| Secondary | Laboratory Measures - Glucose | Glucose blood levels by treatment group and visit. | Available participant lab data for Evaluation and Week 6. | Posted | | Mean | Standard Deviation | mg/dL | | Once during evaluation and once at the end of 6 weeks of study treatment | | | | ID | Title | Description |
|---|
| OG000 | 1: Oxytocin | Subjects randomized to oxytocin will receive oxytocin and placebo-galantamine | | OG001 | 2: Galantamine | Subjects randomized to galantamine will receive galantamine and placebo-oxytocin | | OG002 | 3: Placebo | Subjects randomized to placebo will receive placebo-galantamine and placebo-oxytocin |
| |
| Secondary | Laboratory Measures - Albumin | Albumin blood levels by treatment group and visit. | Available participant lab data for Evaluation and Week 6. | Posted | | Mean | Standard Deviation | g/dL | | Once during evaluation and once at the end of 6 weeks of study treatment | | | | ID | Title | Description |
|---|
| OG000 | 1: Oxytocin | Subjects randomized to oxytocin will receive oxytocin and placebo-galantamine | | OG001 | 2: Galantamine | Subjects randomized to galantamine will receive galantamine and placebo-oxytocin | | OG002 | 3: Placebo | Subjects randomized to placebo will receive placebo-galantamine and placebo-oxytocin |
| |
| Secondary | Laboratory Measures - Globulin | Globulin blood levels by treatment group and visit. | Available participant lab data for Evaluation and Week 6. | Posted | | Mean | Standard Deviation | g/dL | | Once during evaluation and once at the end of 6 weeks of study treatment | | | | ID | Title | Description |
|---|
| OG000 | 1: Oxytocin | Subjects randomized to oxytocin will receive oxytocin and placebo-galantamine | | OG001 | 2: Galantamine | Subjects randomized to galantamine will receive galantamine and placebo-oxytocin | | OG002 | 3: Placebo | Subjects randomized to placebo will receive placebo-galantamine and placebo-oxytocin |
| |
| Secondary | Laboratory Measures - A/G Ratio | Albumin to Globulin (A/G) ratio in the blood by treatment group and visit. | Available participant date for Evaluation and Week 6. | Posted | | Mean | Standard Deviation | g/dL | | Once during evaluation and once at the end of 6 weeks of study treatment | | | | ID | Title | Description |
|---|
| OG000 | 1: Oxytocin | Subjects randomized to oxytocin will receive oxytocin and placebo-galantamine | | OG001 | 2: Galantamine | Subjects randomized to galantamine will receive galantamine and placebo-oxytocin | | OG002 | 3: Placebo | Subjects randomized to placebo will receive placebo-galantamine and placebo-oxytocin |
| |
| Secondary | Laboratory Measures - Bilirubin | Bilirubin blood level by treatment group and visit. | Available participant data for Evaluation and Week 6. | Posted | | Mean | Standard Deviation | mg/dL | | Once during evaluation and once at the end of 6 weeks of study treatment | | | | ID | Title | Description |
|---|
| OG000 | 1: Oxytocin | Subjects randomized to oxytocin will receive oxytocin and placebo-galantamine | | OG001 | 2: Galantamine | Subjects randomized to galantamine will receive galantamine and placebo-oxytocin | | OG002 | 3: Placebo | Subjects randomized to placebo will receive placebo-galantamine and placebo-oxytocin |
| |
| Secondary | Laboratory Measures - Protein | Protein blood level by treatment group and visit. | Available participant data for Evaluation and Week 6. | Posted | | Mean | Standard Deviation | g/dL | | Once during evaluation and once at the end of 6 weeks of study treatment | | | | ID | Title | Description |
|---|
| OG000 | 1: Oxytocin | Subjects randomized to oxytocin will receive oxytocin and placebo-galantamine | | OG001 | 2: Galantamine | Subjects randomized to galantamine will receive galantamine and placebo-oxytocin | | OG002 | 3: Placebo | Subjects randomized to placebo will receive placebo-galantamine and placebo-oxytocin |
| |
| Secondary | Laboratory Measures - BUN | BUN blood level by treatment group and visit. | Available participant data for Evaluation and Week 6. | Posted | | Mean | Standard Deviation | mg/dL | | Once during evaluation and once at the end of 6 weeks of study treatment | | | | ID | Title | Description |
|---|
| OG000 | 1: Oxytocin | Subjects randomized to oxytocin will receive oxytocin and placebo-galantamine | | OG001 | 2: Galantamine | Subjects randomized to galantamine will receive galantamine and placebo-oxytocin | | OG002 | 3: Placebo | Subjects randomized to placebo will receive placebo-galantamine and placebo-oxytocin |
| |
| Secondary | Side Effect Checklist (SEC) - Abdominal Pain | Percentage of participants with new onset or worsening compared to baseline of "Abdominal Pain" rating on the SEC, by Treatment Group. | Safety data for 56 participants exposed to study treatment. | Posted | | Number | | percentage of participants | | Weekly for 6 weeks | | | | ID | Title | Description |
|---|
| OG000 | 1: Oxytocin | Subjects randomized to oxytocin will receive oxytocin and placebo-galantamine | | OG001 | 2: Galantamine | Subjects randomized to galantamine will receive galantamine and placebo-oxytocin | | OG002 | 3: Placebo | Subjects randomized to placebo will receive placebo-galantamine and placebo-oxytocin |
| |
| Secondary | Side Effect Checklist (SEC) - Anorexia | Percentage of participants with new onset or worsening compared to baseline of "Anorexia" rating on the SEC, by Treatment Group. | Safety data for 56 participants exposed to study treatment. | Posted | | Number | | percentage of participants | | Weekly for 6 weeks | | | | ID | Title | Description |
|---|
| OG000 | 1: Oxytocin | Subjects randomized to oxytocin will receive oxytocin and placebo-galantamine | | OG001 | 2: Galantamine | Subjects randomized to galantamine will receive galantamine and placebo-oxytocin | | OG002 | 3: Placebo | Subjects randomized to placebo will receive placebo-galantamine and placebo-oxytocin |
| |
| Secondary | Side Effect Checklist (SEC) - Bruising Easily | Percentage of participants with new onset or worsening compared to baseline of "Bruising Easily" rating on the SEC, by Treatment Group. | Safety data for 56 participants exposed to study treatment. | Posted | | Number | | percentage of participants | | Weekly for 6 weeks | | | | ID | Title | Description |
|---|
| OG000 | 1: Oxytocin | Subjects randomized to oxytocin will receive oxytocin and placebo-galantamine | | OG001 | 2: Galantamine | Subjects randomized to galantamine will receive galantamine and placebo-oxytocin | | OG002 | 3: Placebo | Subjects randomized to placebo will receive placebo-galantamine and placebo-oxytocin |
| |
| Secondary | Side Effect Checklist (SEC) - Constipation | Percentage of participants with new onset or worsening compared to baseline of "Constipation" rating on the SEC, by Treatment Group. | Safety data for 56 participants exposed to study treatment. | Posted | | Number | | percentage of participants | | Weekly for 6 weeks | | | | ID | Title | Description |
|---|
| OG000 | 1: Oxytocin | Subjects randomized to oxytocin will receive oxytocin and placebo-galantamine | | OG001 | 2: Galantamine | Subjects randomized to galantamine will receive galantamine and placebo-oxytocin | | OG002 | 3: Placebo | Subjects randomized to placebo will receive placebo-galantamine and placebo-oxytocin |
| |
| Secondary | Side Effect Checklist (SEC) - Diarrhea | Percentage of participants with new onset or worsening compared to baseline of "Diarrhea" rating on the SEC, by Treatment Group. | Safety data for 56 participants exposed to study treatment. | Posted | | Number | | percentage of participants | | Weekly for 6 weeks | | | | ID | Title | Description |
|---|
| OG000 | 1: Oxytocin | Subjects randomized to oxytocin will receive oxytocin and placebo-galantamine | | OG001 | 2: Galantamine | Subjects randomized to galantamine will receive galantamine and placebo-oxytocin | | OG002 | 3: Placebo | Subjects randomized to placebo will receive placebo-galantamine and placebo-oxytocin |
| |
| Secondary | Side Effect Checklist (SEC) - Dizziness | Percentage of participants with new onset or worsening compared to baseline of "Dizziness" rating on the SEC, by Treatment Group. | Safety data for 56 participants exposed to study treatment. | Posted | | Number | | percentage of participants | | Weekly for 6 weeks | | | | ID | Title | Description |
|---|
| OG000 | 1: Oxytocin | Subjects randomized to oxytocin will receive oxytocin and placebo-galantamine | | OG001 | 2: Galantamine | Subjects randomized to galantamine will receive galantamine and placebo-oxytocin | | OG002 | 3: Placebo | Subjects randomized to placebo will receive placebo-galantamine and placebo-oxytocin |
| |
| Secondary | Side Effect Checklist (SEC) - Dry Eye | Percentage of participants with new onset or worsening compared to baseline of "Dry Eye" rating on the SEC, by Treatment Group. | Safety data for 56 participants exposed to study treatment minus 6 participants who had missing "dry eye" data. | Posted | | Number | | percentage of participants | | Weekly for 6 weeks | | | | ID | Title | Description |
|---|
| OG000 | 1: Oxytocin | Subjects randomized to oxytocin will receive oxytocin and placebo-galantamine | | OG001 | 2: Galantamine | Subjects randomized to galantamine will receive galantamine and placebo-oxytocin | | OG002 | 3: Placebo | Subjects randomized to placebo will receive placebo-galantamine and placebo-oxytocin |
| |
| Secondary | Side Effect Checklist (SEC) - Dry Mouth | Percentage of participants with new onset or worsening compared to baseline of "Dry Mouth" rating on the SEC, by Treatment Group. | Safety data for 56 participants exposed to study treatment. | Posted | | Number | | percentage of participants | | Weekly for 6 weeks | | | | ID | Title | Description |
|---|
| OG000 | 1: Oxytocin | Subjects randomized to oxytocin will receive oxytocin and placebo-galantamine | | OG001 | 2: Galantamine | Subjects randomized to galantamine will receive galantamine and placebo-oxytocin | | OG002 | 3: Placebo | Subjects randomized to placebo will receive placebo-galantamine and placebo-oxytocin |
| |
| Secondary | Side Effect Checklist (SEC) - Enuresis | Percentage of participants with new onset or worsening compared to baseline of "Enuresis" rating on the SEC, by Treatment Group. | Safety data for 56 participants exposed to study treatment. | Posted | | Number | | percentage of participants | | Weekly for 6 weeks | | | | ID | Title | Description |
|---|
| OG000 | 1: Oxytocin | Subjects randomized to oxytocin will receive oxytocin and placebo-galantamine | | OG001 | 2: Galantamine | Subjects randomized to galantamine will receive galantamine and placebo-oxytocin | | OG002 | 3: Placebo | Subjects randomized to placebo will receive placebo-galantamine and placebo-oxytocin |
| |
| Secondary | Side Effect Checklist (SEC) - Excessive Tearing of the Eye | Percentage of participants with new onset or worsening compared to baseline of "Excessive Tearing of the Eye" rating on the SEC, by Treatment Group. | Safety data for 56 participants exposed to study treatment minus 6 participants who had missing "excessive tearing of the eye" data. | Posted | | Number | | percentage of participants | | Weekly for 6 weeks | | | | ID | Title | Description |
|---|
| OG000 | 1: Oxytocin | Subjects randomized to oxytocin will receive oxytocin and placebo-galantamine | | OG001 | 2: Galantamine | Subjects randomized to galantamine will receive galantamine and placebo-oxytocin | | OG002 | 3: Placebo | Subjects randomized to placebo will receive placebo-galantamine and placebo-oxytocin |
| |
| Secondary | Side Effect Checklist (SEC) - Fever | Percentage of participants with new onset or worsening compared to baseline of "Fever" rating on the SEC, by Treatment Group. | Safety data for 56 participants exposed to study treatment. | Posted | | Number | | percentage of participants | | Weekly for 6 weeks | | | | ID | Title | Description |
|---|
| OG000 | 1: Oxytocin | Subjects randomized to oxytocin will receive oxytocin and placebo-galantamine | | OG001 | 2: Galantamine | Subjects randomized to galantamine will receive galantamine and placebo-oxytocin | | OG002 | 3: Placebo | Subjects randomized to placebo will receive placebo-galantamine and placebo-oxytocin |
| |
| Secondary | Side Effect Checklist (SEC) - Headache | Percentage of participants with new onset or worsening compared to baseline of "Headache" rating on the SEC, by Treatment Group. | Safety data for 56 participants exposed to study treatment. | Posted | | Number | | percentage of participants | | Weekly for 6 weeks | | | | ID | Title | Description |
|---|
| OG000 | 1: Oxytocin | Subjects randomized to oxytocin will receive oxytocin and placebo-galantamine | | OG001 | 2: Galantamine | Subjects randomized to galantamine will receive galantamine and placebo-oxytocin | | OG002 | 3: Placebo | Subjects randomized to placebo will receive placebo-galantamine and placebo-oxytocin |
| |
| Secondary | Side Effect Checklist (SEC) - Hyperhydrosis | Percentage of participants with new onset or worsening compared to baseline of "Hyperhydrosis" rating on the SEC, by Treatment Group. | Safety data for 56 participants exposed to study treatment minus 6 participants who had missing "Hyperhydrosis" data. | Posted | | Number | | percentage of participants | | Weekly for 6 weeks | | | | ID | Title | Description |
|---|
| OG000 | 1: Oxytocin | Subjects randomized to oxytocin will receive oxytocin and placebo-galantamine | | OG001 | 2: Galantamine | Subjects randomized to galantamine will receive galantamine and placebo-oxytocin | | OG002 | 3: Placebo | Subjects randomized to placebo will receive placebo-galantamine and placebo-oxytocin |
| |
| Secondary | Side Effect Checklist (SEC) - Hypersalivation | Percentage of participants with new onset or worsening compared to baseline of "Hypersalivation" rating on the SEC, by Treatment Group. | Safety data for 56 participants exposed to study treatment. | Posted | | Number | | percentage of participants | | Weekly for 6 weeks | | | | ID | Title | Description |
|---|
| OG000 | 1: Oxytocin | Subjects randomized to oxytocin will receive oxytocin and placebo-galantamine | | OG001 | 2: Galantamine | Subjects randomized to galantamine will receive galantamine and placebo-oxytocin | | OG002 | 3: Placebo | Subjects randomized to placebo will receive placebo-galantamine and placebo-oxytocin |
| |
| Secondary | Side Effect Checklist (SEC) - Insomnia | Percentage of participants with new onset or worsening compared to baseline of "Insomnia" rating on the SEC, by Treatment Group. | Safety data for 56 participants exposed to study treatment. | Posted | | Number | | percentage of participants | | Weekly for 6 weeks | | | | ID | Title | Description |
|---|
| OG000 | 1: Oxytocin | Subjects randomized to oxytocin will receive oxytocin and placebo-galantamine | | OG001 | 2: Galantamine | Subjects randomized to galantamine will receive galantamine and placebo-oxytocin | | OG002 | 3: Placebo | Subjects randomized to placebo will receive placebo-galantamine and placebo-oxytocin |
| |
| Secondary | Side Effect Checklist (SEC) - Malaise | Percentage of participants with new onset or worsening compared to baseline of "Malaise" rating on the SEC, by Treatment Group. | Safety data for 56 participants exposed to study treatment. | Posted | | Number | | percentage of participants | | Weekly for 6 weeks | | | | ID | Title | Description |
|---|
| OG000 | 1: Oxytocin | Subjects randomized to oxytocin will receive oxytocin and placebo-galantamine | | OG001 | 2: Galantamine | Subjects randomized to galantamine will receive galantamine and placebo-oxytocin | | OG002 | 3: Placebo | Subjects randomized to placebo will receive placebo-galantamine and placebo-oxytocin |
| |
| Secondary | Side Effect Checklist (SEC) - Mucosal Ulceration | Percentage of participants with new onset or worsening compared to baseline of "Mucosal Ulceration" rating on the SEC, by Treatment Group. | Safety data for 56 participants exposed to study treatment. | Posted | | Number | | percentage of participants | | Weekly for 6 weeks | | | | ID | Title | Description |
|---|
| OG000 | 1: Oxytocin | Subjects randomized to oxytocin will receive oxytocin and placebo-galantamine | | OG001 | 2: Galantamine | Subjects randomized to galantamine will receive galantamine and placebo-oxytocin | | OG002 | 3: Placebo | Subjects randomized to placebo will receive placebo-galantamine and placebo-oxytocin |
| |
| Secondary | Side Effect Checklist (SEC) - Nasal Irritation | Percentage of participants with new onset or worsening compared to baseline of "Nasal Irritation" rating on the SEC, by Treatment Group. | Safety data for 56 participants exposed to study treatment minus 6 participants who had missing "nasal irritation" data. | Posted | | Number | | percentage of participants | | Weekly for 6 weeks | | | | ID | Title | Description |
|---|
| OG000 | 1: Oxytocin | Subjects randomized to oxytocin will receive oxytocin and placebo-galantamine | | OG001 | 2: Galantamine | Subjects randomized to galantamine will receive galantamine and placebo-oxytocin | | OG002 | 3: Placebo | Subjects randomized to placebo will receive placebo-galantamine and placebo-oxytocin |
| |
| Secondary | Side Effect Checklist (SEC) - Nausea | Percentage of participants with new onset or worsening compared to baseline of "Nausea" rating on the SEC, by Treatment Group. | Safety data for 56 participants exposed to study treatment. | Posted | | Number | | percentage of participants | | Weekly for 6 weeks | | | | ID | Title | Description |
|---|
| OG000 | 1: Oxytocin | Subjects randomized to oxytocin will receive oxytocin and placebo-galantamine | | OG001 | 2: Galantamine | Subjects randomized to galantamine will receive galantamine and placebo-oxytocin | | OG002 | 3: Placebo | Subjects randomized to placebo will receive placebo-galantamine and placebo-oxytocin |
| |
| Secondary | Side Effect Checklist (SEC) - Rash | Percentage of participants with new onset or worsening compared to baseline of "Rash" rating on the SEC, by Treatment Group. | Safety data for 56 participants exposed to study treatment. | Posted | | Number | | percentage of participants | | Weekly for 6 weeks | | | | ID | Title | Description |
|---|
| OG000 | 1: Oxytocin | Subjects randomized to oxytocin will receive oxytocin and placebo-galantamine | | OG001 | 2: Galantamine | Subjects randomized to galantamine will receive galantamine and placebo-oxytocin | | OG002 | 3: Placebo | Subjects randomized to placebo will receive placebo-galantamine and placebo-oxytocin |
| |
| Secondary | Side Effect Checklist (SEC) - Restlessness | Percentage of participants with new onset or worsening compared to baseline of "Restlessness" rating on the SEC, by Treatment Group. | Safety data for 56 participants exposed to study treatment. | Posted | | Number | | percentage of participants | | Weekly for 6 weeks | | | | ID | Title | Description |
|---|
| OG000 | 1: Oxytocin | Subjects randomized to oxytocin will receive oxytocin and placebo-galantamine | | OG001 | 2: Galantamine | Subjects randomized to galantamine will receive galantamine and placebo-oxytocin | | OG002 | 3: Placebo | Subjects randomized to placebo will receive placebo-galantamine and placebo-oxytocin |
| |
| Secondary | Side Effect Checklist (SEC) - Sedation | Percentage of participants with new onset or worsening compared to baseline of "Sedation" rating on the SEC, by Treatment Group. | Safety data for 56 participants exposed to study treatment. | Posted | | Number | | percentage of participants | | Weekly for 6 weeks | | | | ID | Title | Description |
|---|
| OG000 | 1: Oxytocin | Subjects randomized to oxytocin will receive oxytocin and placebo-galantamine | | OG001 | 2: Galantamine | Subjects randomized to galantamine will receive galantamine and placebo-oxytocin | | OG002 | 3: Placebo | Subjects randomized to placebo will receive placebo-galantamine and placebo-oxytocin |
| |
| Secondary | Side Effect Checklist (SEC) - Sore Throat | Percentage of participants with new onset or worsening compared to baseline of "Sore Throat" rating on the SEC, by Treatment Group. | Safety data for 56 participants exposed to study treatment. | Posted | | Number | | percentage of participants | | Weekly for 6 weeks | | | | ID | Title | Description |
|---|
| OG000 | 1: Oxytocin | Subjects randomized to oxytocin will receive oxytocin and placebo-galantamine | | OG001 | 2: Galantamine | Subjects randomized to galantamine will receive galantamine and placebo-oxytocin | | OG002 | 3: Placebo | Subjects randomized to placebo will receive placebo-galantamine and placebo-oxytocin |
| |
| Secondary | Side Effect Checklist (SEC) - Stiffness | Percentage of participants with new onset or worsening compared to baseline of "Stiffness" rating on the SEC, by Treatment Group. | Safety data for 56 participants exposed to study treatment. | Posted | | Number | | percentage of participants | | Weekly for 6 weeks | | | | ID | Title | Description |
|---|
| OG000 | 1: Oxytocin | Subjects randomized to oxytocin will receive oxytocin and placebo-galantamine | | OG001 | 2: Galantamine | Subjects randomized to galantamine will receive galantamine and placebo-oxytocin | | OG002 | 3: Placebo | Subjects randomized to placebo will receive placebo-galantamine and placebo-oxytocin |
| |
| Secondary | Side Effect Checklist (SEC) - Tinnitus | Percentage of participants with new onset or worsening compared to baseline of "Tinnitus" rating on the SEC, by Treatment Group. | Safety data for 56 participants exposed to study treatment. | Posted | | Number | | percentage of participants | | Weekly for 6 weeks | | | | ID | Title | Description |
|---|
| OG000 | 1: Oxytocin | Subjects randomized to oxytocin will receive oxytocin and placebo-galantamine | | OG001 | 2: Galantamine | Subjects randomized to galantamine will receive galantamine and placebo-oxytocin | | OG002 | 3: Placebo | Subjects randomized to placebo will receive placebo-galantamine and placebo-oxytocin |
| |
| Secondary | Side Effect Checklist (SEC) - Tremor | Percentage of participants with new onset or worsening compared to baseline of "Tremor" rating on the SEC, by Treatment Group. | Safety data for 56 participants exposed to study treatment. | Posted | | Number | | percentage of participants | | Weekly for 6 weeks | | | | ID | Title | Description |
|---|
| OG000 | 1: Oxytocin | Subjects randomized to oxytocin will receive oxytocin and placebo-galantamine | | OG001 | 2: Galantamine | Subjects randomized to galantamine will receive galantamine and placebo-oxytocin | | OG002 | 3: Placebo | Subjects randomized to placebo will receive placebo-galantamine and placebo-oxytocin |
| |
| Secondary | Side Effect Checklist (SEC) - Urticaria | Percentage of participants with new onset or worsening compared to baseline of "Urticaria" rating on the SEC, by Treatment Group. | Safety data for 56 participants exposed to study treatment. | Posted | | Number | | percentage of participants | | Weekly for 6 weeks | | | | ID | Title | Description |
|---|
| OG000 | 1: Oxytocin | Subjects randomized to oxytocin will receive oxytocin and placebo-galantamine | | OG001 | 2: Galantamine | Subjects randomized to galantamine will receive galantamine and placebo-oxytocin | | OG002 | 3: Placebo | Subjects randomized to placebo will receive placebo-galantamine and placebo-oxytocin |
| |
| Secondary | Side Effect Checklist (SEC) - Uterine Contractions | Percentage of participants with new onset or worsening compared to baseline of "Uterine Contractions" rating on the SEC, by Treatment Group. | | Posted | | Number | | percentage of participants | | Weekly for 6 weeks | | | | ID | Title | Description |
|---|
| OG000 | 1: Oxytocin | Subjects randomized to oxytocin will receive oxytocin and placebo-galantamine | | OG001 | 2: Galantamine | Subjects randomized to galantamine will receive galantamine and placebo-oxytocin | | OG002 | 3: Placebo | Subjects randomized to placebo will receive placebo-galantamine and placebo-oxytocin |
| |
| Secondary | Side Effect Checklist (SEC) - Vomiting | Percentage of participants with new onset or worsening compared to baseline of "Vomiting" rating on the SEC, by Treatment Group. | Safety data for 56 participants exposed to study treatment. | Posted | | Number | | percentage of participants | | Weekly for 6 weeks | | | | ID | Title | Description |
|---|
| OG000 | 1: Oxytocin | Subjects randomized to oxytocin will receive oxytocin and placebo-galantamine | | OG001 | 2: Galantamine | Subjects randomized to galantamine will receive galantamine and placebo-oxytocin | | OG002 | 3: Placebo | Subjects randomized to placebo will receive placebo-galantamine and placebo-oxytocin |
| |
| Secondary | Side Effect Checklist (SEC) - Weight Loss | Percentage of participants with new onset or worsening compared to baseline of "Weight Loss" rating on the SEC, by Treatment Group. | Safety data for 56 participants exposed to study treatment. | Posted | | Number | | percentage of participants | | Weekly for 6 weeks | | | | ID | Title | Description |
|---|
| OG000 | 1: Oxytocin | Subjects randomized to oxytocin will receive oxytocin and placebo-galantamine | | OG001 | 2: Galantamine | Subjects randomized to galantamine will receive galantamine and placebo-oxytocin | | OG002 | 3: Placebo | Subjects randomized to placebo will receive placebo-galantamine and placebo-oxytocin |
| |
| Secondary | Side Effect Checklist (SEC) - Wheezing | Percentage of participants with new onset or worsening compared to baseline of "Wheezing" rating on the SEC, by Treatment Group. | Safety data for 56 participants exposed to study treatment minus 6 participants with missing "wheezing" data. | Posted | | Number | | percentage of participants | | Weekly for 6 weeks | | | | ID | Title | Description |
|---|
| OG000 | 1: Oxytocin | Subjects randomized to oxytocin will receive oxytocin and placebo-galantamine | | OG001 | 2: Galantamine | Subjects randomized to galantamine will receive galantamine and placebo-oxytocin | | OG002 | 3: Placebo | Subjects randomized to placebo will receive placebo-galantamine and placebo-oxytocin |
| |
| Secondary | Neurocognitive Assessment Battery (MCCB) - Composite Score | MCCB Composite Score by Week ranging from -10-100 with a higher score indicating a better outcome. | Cognitive data was collected at baseline and week 6, so only those participants who got to week 6 appear in cognitive outcome analyses. | Posted | | Mean | Standard Deviation | units on a scale | | Once at Treatment Week 0 (baseline) and again at Treatment Week 6 (end of treatment). | | | | ID | Title | Description |
|---|
| OG000 | 1: Oxytocin/Placebo-galantamine | Subjects randomized to oxytocin will receive oxytocin and placebo-galantamine | | OG001 | 2: Galantamine/Placebo-oxytocin | Subjects randomized to galantamine will receive galantamine and placebo-oxytocin | | OG002 | 3: Placebo-galantamine /Placebo-oxytocin | Subjects randomized to placebo will receive placebo-galantamine and placebo-oxytocin |
| |
| Secondary | Neurocognitive Assessment Battery (MCCB) - Attention Vigilance | MCCB Attention Vigilance domain score by week calculated from the Continuous Performance Test, Identical Pairs version. The domain score scale is 20-80, with higher scores indicating a better outcome. . | Cognitive data was collected at baseline and week 6, so only those participants who got to week 6 appear in cognitive outcome analyses. | Posted | | Mean | Standard Deviation | units on a scale | | Once at Treatment Week 0 (baseline) and again at Treatment Week 6 (end of treatment). | | | | ID | Title | Description |
|---|
| OG000 | 1: Oxytocin | Subjects randomized to oxytocin will receive oxytocin and placebo-galantamine | | OG001 | 2: Galantamine | Subjects randomized to galantamine will receive galantamine and placebo-oxytocin | | OG002 | 3: Placebo | Subjects randomized to placebo will receive placebo-galantamine and placebo-oxytocin |
| |
| Secondary | Neurocognitive Assessment Battery (MCCB) - Processing Speed | MCCB Processing Speed domain score by week calculated from the Trail Making Test- Part A, Brief Assessment of Cognition in Schizophrenia- symbol coding subtest, and the Category fluency test- animal naming. The domain score scale is 20-80, with higher scores indicating a better outcome. | Cognitive data was collected at baseline and week 6, so only those participants who got to week 6 appear in cognitive outcome analyses. | Posted | | Mean | Standard Deviation | units on a scale | | Once at Treatment Week 0 (baseline) and again at Treatment Week 6 (end of treatment). | | | | ID | Title | Description |
|---|
| OG000 | 1: Oxytocin | Subjects randomized to oxytocin will receive oxytocin and placebo-galantamine | | OG001 | 2: Galantamine | Subjects randomized to galantamine will receive galantamine and placebo-oxytocin | | OG002 | 3: Placebo | Subjects randomized to placebo will receive placebo-galantamine and placebo-oxytocin |
| |
| Secondary | Neurocognitive Assessment Battery (MCCB) - Reasoning/Problem Solving | MCCB Reasoning/Problem Solving domain score by week calculated from the Neuropsychological Assessment Battery- mazes subtest. The domain score scale is 20-80, with higher scores indicating a better outcome. | Cognitive data was collected at baseline and week 6, so only those participants who got to week 6 appear in cognitive outcome analyses. | Posted | | Mean | Standard Deviation | units on a scale | | Once at Treatment Week 0 (baseline) and again at Treatment Week 6 (end of treatment). | | | | ID | Title | Description |
|---|
| OG000 | 1: Oxytocin | Subjects randomized to oxytocin will receive oxytocin and placebo-galantamine | | OG001 | 2: Galantamine | Subjects randomized to galantamine will receive galantamine and placebo-oxytocin | | OG002 | 3: Placebo | Subjects randomized to placebo will receive placebo-galantamine and placebo-oxytocin |
| |
| Secondary | Neurocognitive Assessment Battery (MCCB) - Social Cognition | MCCB Social Cognition domain score by week calculated from the Mayer-Salovey-Caruso Emotional Intelligence Test- managing emotions branch. The domain score scale is 20-80, with higher scores indicating a better outcome. | Cognitive data was collected at baseline and week 6, so only those participants who got to week 6 appear in cognitive outcome analyses. | Posted | | Mean | Standard Deviation | units on a scale | | Once at Treatment Week 0 (baseline) and again at Treatment Week 6 (end of treatment). | | | | ID | Title | Description |
|---|
| OG000 | 1: Oxytocin | Subjects randomized to oxytocin will receive oxytocin and placebo-galantamine | | OG001 | 2: Galantamine | Subjects randomized to galantamine will receive galantamine and placebo-oxytocin | | OG002 | 3: Placebo | Subjects randomized to placebo will receive placebo-galantamine and placebo-oxytocin |
| |
| Secondary | Neurocognitive Assessment Battery (MCCB) - Verbal Learning | MCCB Verbal Learning domain score by week calculated from the Hopkins Verbal Learning Test-Revised, immediate recall (three learning trials only). The domain score scale is 20-80, with higher scores indicating a better outcome. | Cognitive data was collected at baseline and week 6, so only those participants who got to week 6 appear in cognitive outcome analyses. | Posted | | Mean | Standard Deviation | units on a scale | | Once at Treatment Week 0 (baseline) and again at Treatment Week 6 (end of treatment). | | | | ID | Title | Description |
|---|
| OG000 | 1: Oxytocin | Subjects randomized to oxytocin will receive oxytocin and placebo-galantamine | | OG001 | 2: Galantamine | Subjects randomized to galantamine will receive galantamine and placebo-oxytocin | | OG002 | 3: Placebo | Subjects randomized to placebo will receive placebo-galantamine and placebo-oxytocin |
| |
| Secondary | Neurocognitive Assessment Battery (MCCB) - Visual Learning | MCCB Visual Learning domain score by week calculated from the Brief Visuospatial Memory Test-Revised. The domain score scale is 20-80, with higher scores indicating a better outcome. | Cognitive data was collected at baseline and week 6, so only those participants who got to week 6 appear in cognitive outcome analyses. | Posted | | Mean | Standard Deviation | units on a scale | | Once at Treatment Week 0 (baseline) and again at Treatment Week 6 (end of treatment). | | | | ID | Title | Description |
|---|
| OG000 | 1: Oxytocin | Subjects randomized to oxytocin will receive oxytocin and placebo-galantamine | | OG001 | 2: Galantamine | Subjects randomized to galantamine will receive galantamine and placebo-oxytocin | | OG002 | 3: Placebo | Subjects randomized to placebo will receive placebo-galantamine and placebo-oxytocin |
| |
| Secondary | Neurocognitive Assessment Battery (MCCB) - Working Memory | MCCB Working Memory domain score by week calculated from the Wechsler Memory Scale, 3rd ed., spatial span subtest. The domain score scale is 20-80, with higher scores indicating a better outcome. | Cognitive data was collected at baseline and week 6, so only those participants who got to week 6 appear in cognitive outcome analyses. | Posted | | Mean | Standard Deviation | units on a scale | | Once at Treatment Week 0 (baseline) and again at Treatment Week 6 (end of treatment). | | | | ID | Title | Description |
|---|
| OG000 | 1: Oxytocin | Subjects randomized to oxytocin will receive oxytocin and placebo-galantamine | | OG001 | 2: Galantamine | Subjects randomized to galantamine will receive galantamine and placebo-oxytocin | | OG002 | 3: Placebo | Subjects randomized to placebo will receive placebo-galantamine and placebo-oxytocin |
| |
| Secondary | Positive and Negative Affect Schedule (PANAS) - Negative | Participant reported responses after Brief Role Play rating how they felt during the role plays. Participants rated 12 negative affect items on a scale of 1-5, with 1 being "very slightly or not at all" and 5 being "extremely". The minimum score for this measure is 12 and the maximum score is 60. Higher scores indicate a higher rate of negative affect during the role plays. | Role play data was collected at baseline and week 6, so only those participants who completed the role play at week 6 appear in these outcome analyses. | Posted | | Mean | Standard Deviation | units on a scale | | Treatment Week 0 and Week 6 | | | | ID | Title | Description |
|---|
| OG000 | 1: Oxytocin | Subjects randomized to oxytocin will receive oxytocin and placebo-galantamine | | OG001 | 2: Galantamine | Subjects randomized to galantamine will receive galantamine and placebo-oxytocin | | OG002 | 3: Placebo | Subjects randomized to placebo will receive placebo-galantamine and placebo-oxytocin |
| |
| Secondary | Positive and Negative Affect Schedule (PANAS) - Positive | Participant reported responses after Brief Role Play rating how they felt during the role plays. Participants rated 12 positive affect items on a scale of 1-5, with 1 being "very slightly or not at all" and 5 being "extremely". The minimum score for this measure is 12 and the maximum score is 60. Higher scores indicate a higher rate of positive affect during the role plays. | Role play data was collected at baseline and week 6, so only those participants who completed the role play at week 6 appear in these outcome analyses. | Posted | | Mean | Standard Deviation | units on a scale | | Treatment Week 0 and Week 6 | | | | ID | Title | Description |
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| OG000 | 1: Oxytocin | Subjects randomized to oxytocin will receive oxytocin and placebo-galantamine | | OG001 | 2: Galantamine | Subjects randomized to galantamine will receive galantamine and placebo-oxytocin | | OG002 | 3: Placebo | Subjects randomized to placebo will receive placebo-galantamine and placebo-oxytocin |
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| Secondary | Reactions to Partner | Participant reported responses after Brief Role Play. The Reactions to Partner item was calculated by totaling responses to 7 scales. Each scale score ranges from 1-5, which 1 being "completely agree" and 5 being "completely disagree". The minimum score for this measure is 7 and the maximum score is 35. Higher responses indicate a more negative reaction to their role play partner. | Role play data was collected at baseline and week 6, so only those participants who completed the role play at week 6 appear in these outcome analyses. | Posted | | Mean | Standard Deviation | units on a scale | | Treatment Week 0 and Week 6 | | | | ID | Title | Description |
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| OG000 | 1: Oxytocin | Subjects randomized to oxytocin will receive oxytocin and placebo-galantamine | | OG001 | 2: Galantamine | Subjects randomized to galantamine will receive galantamine and placebo-oxytocin | | OG002 | 3: Placebo | Subjects randomized to placebo will receive placebo-galantamine and placebo-oxytocin |
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| Secondary | Willingness to Interact | Participant reported responses after Brief Role Play. The Willingness to Interact item calculated by totaling scores from items 1-6. Each score ranges from 1-5, with 1 being "definitely willing" and 5 being "definitely unwilling". The minimum score for this measure is 6 and the maximum score is 30. Lower scores indicate more willingness to interact with their role play partner again in the future. | Role play data was collected at baseline and week 6, so only those participants who completed the role play at week 6 appear in these outcome analyses. | Posted | | Mean | Standard Deviation | units on a scale | | Treatment Week 0 and Week 6 | | | | ID | Title | Description |
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| OG000 | 1: Oxytocin | Subjects randomized to oxytocin will receive oxytocin and placebo-galantamine | | OG001 | 2: Galantamine | Subjects randomized to galantamine will receive galantamine and placebo-oxytocin | | OG002 | 3: Placebo | Subjects randomized to placebo will receive placebo-galantamine and placebo-oxytocin |
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