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| ID | Type | Description | Link |
|---|---|---|---|
| 1P50MH082999-01 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Mental Health (NIMH) | NIH |
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Schizophrenia is a chronic disorder with onset of psychosis occurring in late teen early twenties, with cognitive impairments and negative symptoms frequently emerging much earlier. Such cognitive impairments and negative symptoms but much milder are also observed in high-risk groups (such as relatives of schizophrenia patients), who may or may not develop the full blown psychotic disorder. Our study plans to recruit such non-ill subjects to test the effects of galantamine on clinical/physiological/cognitive measures. This study serves several goals: If a drug is found effective in treating subtle deficits, then it will provide treatment strategy in individuals with schizophrenia spectrum personality disorders and for early intervention in schizophrenia. In addition, one of the difficulties of testing a drug on schizophrenia is that patients take other medications (i.e., antipsychotic drugs) that can change the effects of the test drug. The proposed study will be in subjects who will not be taking antipsychotic medications. Our study will be carried out in two sessions, at least one month apart. Subjects will be randomly assigned to the two possible order of administration: the drug and then placebo, or the placebo and then drug. Subjects will be given a lead-in 3 days of 4mg/ twice a day of galantamine (or placebo) followed by 8 mg (or placebo) on the 4th day, the day of testing. We will administer a battery of clinical/cognitive/neurophysiological tests after the 8 mg drug dose.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Galantamine, then Placebo | Experimental | Participants took lead-in 3 days of 4mg/ twice a day of galantamine followed by 8 mg on the 4th day, the day of testing. Then, after a period of at least one month, participants took lead-in 3 days of 4mg/ twice a day of placebo followed by 8 mg on the 4th day, the day of testing. |
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| Placebo, then Galantamine | Experimental | Participants took lead-in 3 days of 4mg/ twice a day of placebo followed by 8 mg on the 4th day, the day of testing. Then, after a period of at least one month, participants took lead-in 3 days of 4mg/ twice a day of galantamine followed by 8 mg on the 4th day, the day of testing. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Galantamine | Drug | A lead-in 3 days of 4mg/ twice a day of galantamine (or placebo) followed by 8 mg (or placebo) on the 4th day, the day of testing. |
|
| Measure | Description | Time Frame |
|---|---|---|
| RVIP Target Hit and False Alarm (Number of Responses) | Rapid Visual Information Processing (RVIP) measures primarily sustained attention but perhaps also working memory. The task was continuous stimuli presentation of a stream of single digits (from 1 to 9) presented in the center of the computer monitor at a rate of 1/600milliseconds; the subjects respond when the they see a target sequence of 3 odds or 3 evens in consecutive sequence. Two target sequences are separated by a minimum and maximum of 30 non-target digits. | 25 minutes (duration needed to complete this test) |
| RVIP Reaction Times (ms) | Rapid Visual Information Processing (RVIP) measures primarily sustained attention but perhaps also working memory. The task was continuous stimuli presentation of a stream of single digits (from 1 to 9) presented in the center of the computer monitor at a rate of 1/600milliseconds; the subjects respond when the they see a target sequence of 3 odds or 3 evens in consecutive sequence. Two target sequences are separated by a minimum and maximum of 30 non-target digits. | 25 minutes (total duration to test RVIP) |
| Trust Game (Dollar Amount Earned) | Participants compete in a social trust game in which they are paired with a partner (the computer program). Over the course of 24 rounds he participant can offer up to $10 to their partner. The partner can either accept the offer, in which case the total amount offered is split equally between the participant and their partner (i.e. $10 is split into $5 each). Or the partner can reject the offer and receive a portion of the toal offer for themselves and give the participant nothing ($0). The total amount of money that can be offered ranges from $0-240. | 20 minutes (total duration of the trust game cognitive test) |
| Brief Assessment of Cognition for Schizophrenia (BACS) Score | The BACS Symbol Coding subtest will be used to assess processing speed, and the demographically corrected T score, will be used for data analysis. This test requires less than 5 minutes to administer adn provides a highly reliable measure of processing speed. There are nine symbols coded 1 through 9. Participants are given 90 seconds to match a series of these symbols with their corresponding number. The total correct matches in the participants score. Scores range from 0-110. |
| Measure | Description | Time Frame |
|---|---|---|
| Social Affiliation Measured by Social Affiliative Role Play (Rating Scale Score) | In a videotaped session, research staff engages the participant in social interaction based on a role play. The tape is rated on social skills and on Positive and Negative Affect Scale. participants are rated on a 5 point likert scale ranging from very poor (1) to very good (5) | 30 minutes (time needed to complete this test) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| L. E. Hong, M.D. | University of Maryland, Baltimore | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Maryland, Baltimore | Baltimore | Maryland | 21228 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Galantamine, Then Placebo | Participants took lead-in 3 days of 4mg/ twice a day of galantamine followed by 8 mg on the 4th day, the day of testing. Then, after a period of at least one month, participants took lead-in 3 days of 4mg/ twice a day of placebo followed by 8 mg on the 4th day, the day of testing. Galantamine: A lead-in 3 days of 4mg/ twice a day of galantamine (or placebo) followed by 8 mg (or placebo) on the 4th day, the day of testing. Placebo: Subjects will be randomly assigned to the two possible order of administration: the drug and then placebo, or the placebo and then drug. Subjects will be given a lead-in 3 days of 4mg/ twice a day of galantamine (or placebo) followed by 8 mg (or placebo) on the 4th day, the day of testing. |
| FG001 | Placebo, Then Galantamine | Participants took lead-in 3 days of 4mg/ twice a day of placebo followed by 8 mg on the 4th day, the day of testing. Then, after a period of at least one month, participants took lead-in 3 days of 4mg/ twice a day of galantamine followed by 8 mg on the 4th day, the day of testing. Galantamine: A lead-in 3 days of 4mg/ twice a day of galantamine (or placebo) followed by 8 mg (or placebo) on the 4th day, the day of testing. Placebo: Subjects will be randomly assigned to the two possible order of administration: the drug and then placebo, or the placebo and then drug. Subjects will be given a lead-in 3 days of 4mg/ twice a day of galantamine (or placebo) followed by 8 mg (or placebo) on the 4th day, the day of testing. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | All Study Participants | All participants that were included in the study |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | RVIP Target Hit and False Alarm (Number of Responses) | Rapid Visual Information Processing (RVIP) measures primarily sustained attention but perhaps also working memory. The task was continuous stimuli presentation of a stream of single digits (from 1 to 9) presented in the center of the computer monitor at a rate of 1/600milliseconds; the subjects respond when the they see a target sequence of 3 odds or 3 evens in consecutive sequence. Two target sequences are separated by a minimum and maximum of 30 non-target digits. | Analyzable data for all participants was not available | Posted | Mean | Standard Deviation | Number of responses | 25 minutes (duration needed to complete this test) |
|
Collected over the course of 2 approximately 8 hour study days
The Side Effect Checklist was used
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Galantamine | Participants took lead-in 3 days of 4mg/ twice a day of galantamine followed by 8 mg on the 4th day, the day of testing. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Dizziness | General disorders | SEC | Systematic Assessment | Participant reported felling dizzy after taking study medication or placebo |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Ms. Dawn Detamore | University of Maryland Baltimore | 410 402 6820 | DDetamore@som.umaryland.edu |
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| ID | Term |
|---|---|
| D012559 | Schizophrenia |
| ID | Term |
|---|---|
| D019967 | Schizophrenia Spectrum and Other Psychotic Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D005702 | Galantamine |
| ID | Term |
|---|---|
| D047151 | Amaryllidaceae Alkaloids |
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
| D001552 | Benzazepines |
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|
| Placebo | Drug | Subjects will be randomly assigned to the two possible order of administration: the drug and then placebo, or the placebo and then drug. Subjects will be given a lead-in 3 days of 4mg/ twice a day of galantamine (or placebo) followed by 8 mg (or placebo) on the 4th day, the day of testing. |
|
| 5 minutes (duration needed to complete the assessment) |
| Hopkins Verbal Learning Test (HVLT) Score | HVLT comes in 6 different forms. Forms 4 and 5 were used for this study with one form administered on the first day and the other on the second and were counterbalanced between subjects. Each form contains 12 nouns, four words each from one of three semantic categories, to be learned over the course of three learning trials. | 15 minutes (duration needed to complete this test) |
| Reading the Mind in the Eyes Score (Number of Correct Responses) | A 30 item task presents a picture of a person's eyes and the participant is asked to determine the person's mental state from 4 multiple choice options. | 10 minutes (duration needed to complete the test) |
| The Brief Smell Identification Test (B-SIT) Score (Number of Correct Responses) | The Brief Smell Identification Test (B-SIT) is a 5-minute, 12-item screening test. Participants try to identify 12 different odors with four multiple choice options given for each odor. | 5 minutes (duration usually needed to complete this test) |
| Facial Affect Recognition Score (Number of Responses) | This computer administered test includes 40 color photogralhs of four emotions (happy, sad, angry, and fearful) balanced for the posers gender, age and ethnicity, including four low intensity and four high intensity facila expressions of each emotion, plus 8 neutral faces. The stimuli are presented in random order and subjects are asked to identify which stimuli were presented to them at the end. Performance on this test correlates with negative symptom severity | 10 minutes (time usually needed to complete this test) |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG001 | Placebo | Participants took lead-in 3 days of 4mg/ twice a day of placebo followed by 8 mg on the 4th day, the day of testing. |
|
|
|
| Primary | RVIP Reaction Times (ms) | Rapid Visual Information Processing (RVIP) measures primarily sustained attention but perhaps also working memory. The task was continuous stimuli presentation of a stream of single digits (from 1 to 9) presented in the center of the computer monitor at a rate of 1/600milliseconds; the subjects respond when the they see a target sequence of 3 odds or 3 evens in consecutive sequence. Two target sequences are separated by a minimum and maximum of 30 non-target digits. | Analyzable data for all participants was not available | Posted | Mean | Standard Deviation | milliseconds | 25 minutes (total duration to test RVIP) |
|
|
|
|
| Primary | Trust Game (Dollar Amount Earned) | Participants compete in a social trust game in which they are paired with a partner (the computer program). Over the course of 24 rounds he participant can offer up to $10 to their partner. The partner can either accept the offer, in which case the total amount offered is split equally between the participant and their partner (i.e. $10 is split into $5 each). Or the partner can reject the offer and receive a portion of the toal offer for themselves and give the participant nothing ($0). The total amount of money that can be offered ranges from $0-240. | Analyzable data for all participants was not available | Posted | Mean | Standard Deviation | Dollars | 20 minutes (total duration of the trust game cognitive test) |
|
|
|
|
| Primary | Brief Assessment of Cognition for Schizophrenia (BACS) Score | The BACS Symbol Coding subtest will be used to assess processing speed, and the demographically corrected T score, will be used for data analysis. This test requires less than 5 minutes to administer adn provides a highly reliable measure of processing speed. There are nine symbols coded 1 through 9. Participants are given 90 seconds to match a series of these symbols with their corresponding number. The total correct matches in the participants score. Scores range from 0-110. | Analyzable data for all participants was not available | Posted | Mean | Standard Deviation | Number of correct responses | 5 minutes (duration needed to complete the assessment) |
|
|
|
|
| Primary | Hopkins Verbal Learning Test (HVLT) Score | HVLT comes in 6 different forms. Forms 4 and 5 were used for this study with one form administered on the first day and the other on the second and were counterbalanced between subjects. Each form contains 12 nouns, four words each from one of three semantic categories, to be learned over the course of three learning trials. | Analyzable data for all participants was not available | Posted | Mean | Standard Deviation | Number of correct responses | 15 minutes (duration needed to complete this test) |
|
|
|
|
| Primary | Reading the Mind in the Eyes Score (Number of Correct Responses) | A 30 item task presents a picture of a person's eyes and the participant is asked to determine the person's mental state from 4 multiple choice options. | Analyzable data was not available for all participants | Posted | Mean | Standard Deviation | Number of correct responses | 10 minutes (duration needed to complete the test) |
|
|
|
|
| Primary | The Brief Smell Identification Test (B-SIT) Score (Number of Correct Responses) | The Brief Smell Identification Test (B-SIT) is a 5-minute, 12-item screening test. Participants try to identify 12 different odors with four multiple choice options given for each odor. | analyzable data for all participant was not available | Posted | Mean | Standard Deviation | Number of correct responses | 5 minutes (duration usually needed to complete this test) |
|
|
|
|
| Secondary | Social Affiliation Measured by Social Affiliative Role Play (Rating Scale Score) | In a videotaped session, research staff engages the participant in social interaction based on a role play. The tape is rated on social skills and on Positive and Negative Affect Scale. participants are rated on a 5 point likert scale ranging from very poor (1) to very good (5) | analyzable data was not available for all participants | Posted | Mean | Standard Deviation | units on a scale | 30 minutes (time needed to complete this test) |
|
|
|
|
| Secondary | Facial Affect Recognition Score (Number of Responses) | This computer administered test includes 40 color photogralhs of four emotions (happy, sad, angry, and fearful) balanced for the posers gender, age and ethnicity, including four low intensity and four high intensity facila expressions of each emotion, plus 8 neutral faces. The stimuli are presented in random order and subjects are asked to identify which stimuli were presented to them at the end. Performance on this test correlates with negative symptom severity | analyzable data was not available for all participants | Posted | Mean | Standard Deviation | Number of Responses | 10 minutes (time usually needed to complete this test) |
|
|
|
|
| 0 |
| 12 |
| 0 |
| 12 |
| 4 |
| 12 |
| EG001 | Placebo | Participants took lead-in 3 days of 4mg/ twice a day of placebo followed by 8 mg on the 4th day, the day of testing. | 0 | 12 | 0 | 12 | 1 | 12 |
|
| Euphoria | General disorders | SEC | Systematic Assessment | Participant reported felling euphoric during testing |
|
| Drowsiness | General disorders | SEC | Systematic Assessment | Participant reported feeling drowsy during testing |
|
| Blurred Vision | General disorders | SEC | Systematic Assessment | Participant reported blurry vision during testing |
|
| Tearing of Eyes | General disorders | SEC | Systematic Assessment | Participant reported tearing in their eyes during testing |
|
| Insomnia | General disorders | SEC | Systematic Assessment | Participant reported difficulty sleeping after starting study medication or placebo |
|
| Nausea | General disorders | SEC | Systematic Assessment | Participant reported felling nauseous after starting study medication or placebo |
|
| Headache | General disorders | SEC | Systematic Assessment | Participant reported headache after starting study medication or placebo |
|
| Malaise | General disorders | SEC | Systematic Assessment | Participant reported malaise/physical fatigue after starting study medication or placebo |
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| Sedation | General disorders | SEC | Systematic Assessment | Participant reported sedation after starting study medication or placebo |
|
| Dry mouth | General disorders | SEC | Systematic Assessment | Participant reported dry mouth after starting study medication or placebo |
|
| Abdominal Pain | General disorders | SEC | Systematic Assessment | Participant reported abdominal pain after starting study medication or placebo |
|
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| D006574 |
| Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| RVIP First Half Mean Target Reaction Time |
|
| RVIP First Half Mean False Alarm Reaction Time |
|
| Wilcoxon (Mann-Whitney) |
| 0.028 |
| Superiority |
| Comparison of RVIP First Half Mean Target Reaction Time between Galantamine and Placebo Arms | Wilcoxon (Mann-Whitney) | 0.899 | Superiority |
| Comparison of RVIP First Half Mean False Alarms Reaction Time between Galantamine and Placebo Arms | Wilcoxon (Mann-Whitney) | 0.521 | Superiority |
| HVLT Trial 3 |
|
| Wilcoxon (Mann-Whitney) |
| 0.541 |
| Superiority |
| Comparison of the number of correct response on Trial 3 between galantamine and placebo | Wilcoxon (Mann-Whitney) | 0.838 | Superiority |
| 0.234 |
| Superiority |
| Facial Affect False Alarms |
|
| 0.669 |
| Superiority |
| Comparison of Facial Affect Total False Alarms between galantamine and placebo | Wilcoxon (Mann-Whitney) | 0.668 | Superiority |