Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Treatment of schizophrenia currently includes antipsychotic medications and cognitive therapies which improve some symptoms, but do not sufficiently restore cognitive functioning or reduce psychosocial disability. We hypothesize that medications that specifically target sensory information processing deficits, rather than psychotic symptoms per se, will significantly enhance the benefits of a sensory-based targeted cognitive training (TCT) intervention in patients with schizophrenia. We will complete a randomized, double-blind clinical trial to: 1) confirm that the drug memantine augments TCT learning; 2) determine whether memantine enhances the clinical benefits from a full 30 session course of TCT vs. TCT plus placebo in antipsychotic- medicated schizophrenia patients, and 3) determine if memantine's enhancement of TCT is most effective in biomarker-defined subgroups of patients.
Treatment of schizophrenia (SZ) currently includes antipsychotic medications and cognitive therapies which improve some symptoms, but do not sufficiently restore cognitive functioning or reduce psychosocial disability. We propose and will test a novel "augmentation strategy" for using medications to specifically enhance the benefits of targeted cognitive training (TCT) in schizophrenia. This project tests a rational and empirically supported platform for augmenting the benefits of TCT in antipsychotic medicated SZ patients by adjunctive daily treatment of 20 mg memantine, an FDA approved medication for the treatment of cognitive dysfunction in Alzheimer's Disease. We hypothesize that medications that specifically target sensory information processing deficits, rather than psychotic symptoms per se, will significantly enhance the benefits of a sensory-based targeted cognitive training (TCT) intervention in patients with schizophrenia. We will complete a randomized, double-blind clinical trial to: 1) confirm that the drug memantine augments TCT learning; 2) determine whether memantine enhances the clinical benefits from a full 30 session course of TCT vs. TCT plus placebo in antipsychotic- medicated schizophrenia patients, and 3) determine if memantine's enhancement of TCT is most effective in biomarker-defined subgroups of patients.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TCT + PBO | Placebo Comparator | Subjects will be assigned to take placebo and will complete 30 hours of targeted cognitive training in order to assess whether memantine enhances cognitive training performance |
|
| TCT + MEM | Active Comparator | Subjects will be assigned to take memantine and will complete 30 hours of targeted cognitive training in order to assess whether memantine enhances cognitive training performance |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Memantine | Drug | Subjects will be assigned to take memantine or placebo and will complete 30 hours of targeted cognitive training in order to assess whether memantine enhances cognitive training performance |
| Measure | Description | Time Frame |
|---|---|---|
| Positive & Negative Symptom Scale Total (PANSSt) | PANSS Total Score is the primary clinical outcome measured at baseline vs. post TCT session 10, 20 and 30 (approximately 16 weeks). The PANSS total score has a range 30-210, with higher scores indicating worse outcome. | Baseline (at study enrollment), post-10 TCT sessions (approximately week 10), post-20 TCT sessions (approximately week 13) and post-30 TCT sessions (approximately week 16). |
| World Health Organization Disability Schedule (WHODAS 2.0) | Function will be assessed via the World Health Organization Disability Schedule 2.0 (WHODAS 2.0) at baseline vs. post-TCT session 10, 20 and 30 (approximately 16 weeks). The World Health Organization Disability Schedule (WHODAS 2.0) has a range 12-60, with higher scores indicating worse outcome. | Baseline (at study enrollment), post-10 TCT sessions (approximately week 10), post-20 TCT sessions (approximately week 13) and post-30 TCT sessions (approximately week 16). |
| MATRICS Consensus Cognitive Battery Global Composite T-score (MCCB-C) | The MCCB Global Composite T-score (MCCB-C) is the primary neurocognitive outcome measured at baseline vs. post-TCT session 10, 20 and 30 (approximately 16 weeks). The MATRICS Consensus Cognitive Battery (MCCB) composite T-score has no minimum or maximum score because it uses T-scores (e.g., 50 indicates the population mean with a standard deviation of 10), which are standardized based on a community sample. A normal range MCCB composite T-score is between 40 and 60 and higher scores indicate better neurocognitive outcome. | Baseline (at study enrollment), post-10 TCT sessions (approximately week 10), post-20 TCT sessions (approximately week 13) and post-30 TCT sessions (approximately week 16). |
| Measure | Description | Time Frame |
|---|---|---|
| Positive & Negative Symptom Scale (PANSS) - Positive Symptom Subscale | Positive & Negative Symptom Scale (PANSS) positive symptom subscale measured at baseline vs. post-TCT session 10, 20 and 30 (approximately 16 weeks). The PANSS positive symptom subscale is rated from 1 to 7 points ranging from absent to extreme. The range for the Positive Symptom subscale is 7-49 and higher scores indicate worse outcome. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinical Teaching Facility (CTF B-403 at UCSD Medical Center) | San Diego | California | 92103 | United States |
There is no plan to share individual participant data with other researchers
Not provided
Not provided
Not provided
Not provided
A total of 62 participants were enrolled but 15 were excluded for not meeting inclusion criteria and 5 withdrew from the study. Two withdrew before initiation of treatment; therefore 40 participants were included. 17 were randomized to placebo and 23 were randomized to memantine.
Antipsychotic-medicated outpatients with a primary diagnosis of SZ or schizoaffective disorder (depressed type) ages 18-65 were recruited from the San Diego community between 7/6/2021 and 11/15/2023. Of the 62 consented/enrolled participants, 42 met inclusion criteria and were randomized to treatment, however 2 dropped out prior to initiation of treatment. Therefore 40 subjects participated in the trial.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | TCT + PBO | Subjects will be assigned to take placebo and will complete 30 hours of targeted cognitive training in order to assess whether memantine enhances cognitive training performance |
| FG001 | TCT + MEM | Subjects will be assigned to take memantine and will complete 30 hours of targeted cognitive training in order to assess whether memantine enhances cognitive training performance |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | TCT + PBO | Subjects will be assigned to take placebo and will complete 30 hours of targeted cognitive training in order to assess whether memantine enhances cognitive training performance |
| BG001 | TCT + MEM |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Age in years at study enrollment |
| 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 | Positive & Negative Symptom Scale Total (PANSSt) | PANSS Total Score is the primary clinical outcome measured at baseline vs. post TCT session 10, 20 and 30 (approximately 16 weeks). The PANSS total score has a range 30-210, with higher scores indicating worse outcome. | 17 subjects were randomized to placebo and 23 to memantine. 3 subjects withdrew and 1 was excluded for a positive toxicology test; therefore 15 placebo and 21 memantine subjects completed the post-10 assessment. 1 placebo and 3 memantine subjects withdrew prior to the post-20 assessment. One additional memantine subject withdrew so that 13 placebo and 17 memantine subjects completed the post-30 assessment. Data tables include only those subjects who completed all assessments through post-30. | Posted | Mean | Standard Deviation | score on a scale | Baseline (at study enrollment), post-10 TCT sessions (approximately week 10), post-20 TCT sessions (approximately week 13) and post-30 TCT sessions (approximately week 16). |
|
From randomization until end of follow-up, up to 13 weeks
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | TCT + PBO | Subjects will be assigned to take placebo and will complete 30 hours of targeted cognitive training in order to assess whether memantine enhances cognitive training performance |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Positive CSSRS | Psychiatric disorders | Systematic Assessment | Positive Columbia Suicide Severity Rating Scale (CSSRS)- Assesses suicidal ideation |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Gregory A. Light, Ph.D. | University of California San Diego, Department of Psychiatry | 619-316-6242 | glight@health.ucsd.edu |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Feb 14, 2020 | Jan 30, 2026 | Prot_SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | May 10, 2022 | Dec 10, 2024 | ICF_000.pdf |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D012559 | Schizophrenia |
| D011618 | Psychotic Disorders |
| ID | Term |
|---|---|
| D019967 | Schizophrenia Spectrum and Other Psychotic Disorders |
| D001523 | Mental Disorders |
Not provided
Not provided
| ID | Term |
|---|---|
| D008559 | Memantine |
| ID | Term |
|---|---|
| D000547 | Amantadine |
| D000218 | Adamantane |
| D001952 | Bridged-Ring Compounds |
| D006844 | Hydrocarbons, Cyclic |
Not provided
Not provided
Subjects will be randomized to targeted cognitive training (TCT) and memantine (MEM) or targeted cognitive training (TCT) and placebo (PBO)
Not provided
Not provided
Subjects will be randomized to TCT and memantine or TCT and placebo. The research will be provided with a randomization scheme to follow and will dispense the pills identified only by a code.
|
| Placebo | Drug | Subjects will be assigned to take memantine or placebo and will complete 30 hours of targeted cognitive training in order to assess whether memantine enhances cognitive training performance |
|
|
| Baseline (at study enrollment), post-10 TCT sessions (approximately week 10), post-20 TCT sessions (approximately week 13) and post-30 TCT sessions (approximately week 16). |
| Positive & Negative Symptom Scale (PANSS) - Negative Symptom Subscale | Positive & Negative Symptom Scale (PANSS) negative symptom subscale measured at baseline vs. post-TCT session 10, 20 and 30 (approximately 16 weeks). The PANSS negative symptom subscale is rated from 1 to 7 points ranging from absent to extreme. The range for the negative symptom subscale is 7-49 and higher scores indicate worse outcome. | Baseline (at study enrollment), post-10 TCT sessions (approximately week 10), post-20 TCT sessions (approximately week 13) and post-30 TCT sessions (approximately week 16). |
| Psychotic Symptoms - PSYRATS Hallucination Subscale | Psychotic Symptom Rating Scales (PSYRATS hallucination subscale) measured at baseline vs. post-TCT session 10, 20 and 30 (approximately 16 weeks). The PSYRATS auditory hallucinations subscale (AHS) consisting of 11 items, with each item being rated from 0 (absent) to 4 (severe), range 0-44, with higher scores indicating more severe auditory hallucinations or worse outcome. | Baseline (at study enrollment), post-10 TCT sessions (approximately week 10), post-20 TCT sessions (approximately week 13) and post-30 TCT sessions (approximately week 16). |
| Manic Symptoms - Young Mania Rating Scale | Young Mania Rating Scale total score measured at baseline vs. post-TCT session 10, 20 and 30 (approximately 16 weeks). The range for the YMRS total score is 0-60, with higher scores indicating more severe manic symptoms or worse outcome. | Baseline (at study enrollment), post-10 TCT sessions (approximately week 10), post-20 TCT sessions (approximately week 13) and post-30 TCT sessions (approximately week 16). |
| Current Depressive Symptoms - PHQ-9 | Patient Health Questionnaire-9 (PHQ-9) total score measured at baseline vs. post-TCT session 10, 20 and 30 (approximately 16 weeks). The PHQ-9 has a range from 0 to 27 with higher scores indicating more severe depression or worse outcome. | Baseline (at study enrollment), post-10 TCT sessions (approximately week 10), post-20 TCT sessions (approximately week 13) and post-30 TCT sessions (approximately week 16). |
Subjects will be assigned to take memantine and will complete 30 hours of targeted cognitive training in order to assess whether memantine enhances cognitive training performance
| BG002 | Total | Total of all reporting groups |
| Mean |
| Standard Deviation |
| years |
|
| Sex: Female, Male | Sex (Female, Male) as reported by participant | Count of Participants | Participants |
|
| Race (NIH/OMB) | Race as reported by participant | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Ethnicity (Hispanic or Not Hispanic) as reported by participant | Count of Participants | Participants |
|
| Region of Enrollment | Region of enrollment- United States- San Diego CA | Number | Participants |
|
| Duration of illness | Duration of illness as reported by participant | Mean | Standard Deviation | years |
|
| TCT + PBO |
Subjects will be assigned to take placebo and will complete 30 hours of targeted cognitive training in order to assess whether memantine enhances cognitive training performance |
| OG001 | TCT + MEM | Subjects will be assigned to take memantine and will complete 30 hours of targeted cognitive training in order to assess whether memantine enhances cognitive training performance |
|
|
|
| Primary | World Health Organization Disability Schedule (WHODAS 2.0) | Function will be assessed via the World Health Organization Disability Schedule 2.0 (WHODAS 2.0) at baseline vs. post-TCT session 10, 20 and 30 (approximately 16 weeks). The World Health Organization Disability Schedule (WHODAS 2.0) has a range 12-60, with higher scores indicating worse outcome. | 17 subjects were randomized to placebo and 23 to memantine. 3 subjects withdrew and 1 was excluded for a positive toxicology test; therefore 15 placebo and 21 memantine subjects completed the post-10 assessment. 1 placebo and 3 memantine subjects withdrew prior to the post-20 assessment. One additional memantine subject withdrew so that 13 placebo and 17 memantine subjects completed the post-30 assessment. Data tables include only those subjects who completed all assessments through post-30. | Posted | Mean | Standard Deviation | score on a scale | Baseline (at study enrollment), post-10 TCT sessions (approximately week 10), post-20 TCT sessions (approximately week 13) and post-30 TCT sessions (approximately week 16). |
|
|
|
|
| Primary | MATRICS Consensus Cognitive Battery Global Composite T-score (MCCB-C) | The MCCB Global Composite T-score (MCCB-C) is the primary neurocognitive outcome measured at baseline vs. post-TCT session 10, 20 and 30 (approximately 16 weeks). The MATRICS Consensus Cognitive Battery (MCCB) composite T-score has no minimum or maximum score because it uses T-scores (e.g., 50 indicates the population mean with a standard deviation of 10), which are standardized based on a community sample. A normal range MCCB composite T-score is between 40 and 60 and higher scores indicate better neurocognitive outcome. | 17 subjects were randomized to placebo and 23 to memantine. 3 subjects withdrew and 1 was excluded for a positive toxicology test; therefore 15 placebo and 21 memantine subjects completed the post-10 assessment. 1 placebo and 3 memantine subjects withdrew prior to the post-20 assessment. One additional memantine subject withdrew so that 13 placebo and 17 memantine subjects completed the post-30 assessment. Data tables include only those subjects who completed all assessments through post-30. | Posted | Mean | Standard Deviation | T-score | Baseline (at study enrollment), post-10 TCT sessions (approximately week 10), post-20 TCT sessions (approximately week 13) and post-30 TCT sessions (approximately week 16). |
|
|
|
|
| Secondary | Positive & Negative Symptom Scale (PANSS) - Positive Symptom Subscale | Positive & Negative Symptom Scale (PANSS) positive symptom subscale measured at baseline vs. post-TCT session 10, 20 and 30 (approximately 16 weeks). The PANSS positive symptom subscale is rated from 1 to 7 points ranging from absent to extreme. The range for the Positive Symptom subscale is 7-49 and higher scores indicate worse outcome. | 17 subjects were randomized to placebo and 23 to memantine. 3 subjects withdrew and 1 was excluded for a positive toxicology test; therefore 15 placebo and 21 memantine subjects completed the post-10 assessment. 1 placebo and 3 memantine subjects withdrew prior to the post-20 assessment. One additional memantine subject withdrew so that 13 placebo and 17 memantine subjects completed the post-30 assessment. Data tables include only those subjects who completed all assessments through post-30. | Posted | Mean | Standard Deviation | score on a scale | Baseline (at study enrollment), post-10 TCT sessions (approximately week 10), post-20 TCT sessions (approximately week 13) and post-30 TCT sessions (approximately week 16). |
|
|
|
|
| Secondary | Positive & Negative Symptom Scale (PANSS) - Negative Symptom Subscale | Positive & Negative Symptom Scale (PANSS) negative symptom subscale measured at baseline vs. post-TCT session 10, 20 and 30 (approximately 16 weeks). The PANSS negative symptom subscale is rated from 1 to 7 points ranging from absent to extreme. The range for the negative symptom subscale is 7-49 and higher scores indicate worse outcome. | 17 subjects were randomized to placebo and 23 to memantine. 3 subjects withdrew and 1 was excluded for a positive toxicology test; therefore 15 placebo and 21 memantine subjects completed the post-10 assessment. 1 placebo and 3 memantine subjects withdrew prior to the post-20 assessment. One additional memantine subject withdrew so that 13 placebo and 17 memantine subjects completed the post-30 assessment. Data tables include only those subjects who completed all assessments through post-30. | Posted | Mean | Standard Deviation | score on a scale | Baseline (at study enrollment), post-10 TCT sessions (approximately week 10), post-20 TCT sessions (approximately week 13) and post-30 TCT sessions (approximately week 16). |
|
|
|
|
| Secondary | Psychotic Symptoms - PSYRATS Hallucination Subscale | Psychotic Symptom Rating Scales (PSYRATS hallucination subscale) measured at baseline vs. post-TCT session 10, 20 and 30 (approximately 16 weeks). The PSYRATS auditory hallucinations subscale (AHS) consisting of 11 items, with each item being rated from 0 (absent) to 4 (severe), range 0-44, with higher scores indicating more severe auditory hallucinations or worse outcome. | 17 subjects were randomized to placebo and 23 to memantine. 3 subjects withdrew and 1 was excluded for a positive toxicology test; therefore 15 placebo and 21 memantine subjects completed the post-10 assessment. 1 placebo and 3 memantine subjects withdrew prior to the post-20 assessment. One additional memantine subject withdrew so that 13 placebo and 17 memantine subjects completed the post-30 assessment. Data tables include only those subjects who completed all assessments through post-30. | Posted | Mean | Standard Deviation | score on a scale | Baseline (at study enrollment), post-10 TCT sessions (approximately week 10), post-20 TCT sessions (approximately week 13) and post-30 TCT sessions (approximately week 16). |
|
|
|
|
| Secondary | Manic Symptoms - Young Mania Rating Scale | Young Mania Rating Scale total score measured at baseline vs. post-TCT session 10, 20 and 30 (approximately 16 weeks). The range for the YMRS total score is 0-60, with higher scores indicating more severe manic symptoms or worse outcome. | 17 subjects were randomized to placebo and 23 to memantine. 3 subjects withdrew and 1 was excluded for a positive toxicology test; therefore 15 placebo and 21 memantine subjects completed the post-10 assessment. 1 placebo and 3 memantine subjects withdrew prior to the post-20 assessment. One additional memantine subject withdrew so that 13 placebo and 17 memantine subjects completed the post-30 assessment. Data tables include only those subjects who completed all assessments through post-30. | Posted | Mean | Standard Deviation | score on a scale | Baseline (at study enrollment), post-10 TCT sessions (approximately week 10), post-20 TCT sessions (approximately week 13) and post-30 TCT sessions (approximately week 16). |
|
|
|
|
| Secondary | Current Depressive Symptoms - PHQ-9 | Patient Health Questionnaire-9 (PHQ-9) total score measured at baseline vs. post-TCT session 10, 20 and 30 (approximately 16 weeks). The PHQ-9 has a range from 0 to 27 with higher scores indicating more severe depression or worse outcome. | 17 subjects were randomized to placebo and 23 to memantine. 3 subjects withdrew and 1 was excluded for a positive toxicology test; therefore 15 placebo and 21 memantine subjects completed the post-10 assessment. 1 placebo and 3 memantine subjects withdrew prior to the post-20 assessment. One additional memantine subject withdrew so that 13 placebo and 17 memantine subjects completed the post-30 assessment. Data tables include only those subjects who completed all assessments through post-30. | Posted | Mean | Standard Deviation | score on a scale | Baseline (at study enrollment), post-10 TCT sessions (approximately week 10), post-20 TCT sessions (approximately week 13) and post-30 TCT sessions (approximately week 16). |
|
|
|
|
| 0 |
| 17 |
| 0 |
| 17 |
| 11 |
| 17 |
| EG001 | TCT + MEM | Subjects will be assigned to take memantine and will complete 30 hours of targeted cognitive training in order to assess whether memantine enhances cognitive training performance | 0 | 23 | 0 | 23 | 10 | 23 |
|
| Positive tox | Psychiatric disorders | Systematic Assessment | Positive urine toxicology test results-assesses presence of multiple drugs of abuse |
|
| High BP | Cardiac disorders | Systematic Assessment | Elevated blood pressure |
|
| Worsening symptoms | Psychiatric disorders | Systematic Assessment | Increased psychiatric symptoms |
|
| GI Symptoms | Gastrointestinal disorders | Systematic Assessment | Gastrointestinal symptoms |
|
| Abdominal pain | Gastrointestinal disorders | Systematic Assessment |
|
| Trip/fall | General disorders | Systematic Assessment | Reports trip or fall causing minor injury |
|
| Positive COVID | Infections and infestations | Systematic Assessment | Positive COVID as reported by subject |
|
| Knee infection | Infections and infestations | Systematic Assessment | Knee infection as reported by subject |
|
| Gout | Immune system disorders | Systematic Assessment | Gout as reported by subject |
|
| UTI Symptoms | Infections and infestations | Systematic Assessment | Urinary tract infection (UTI) symptoms as reported by subject |
|
Not provided
Not provided
| D006838 |
| Hydrocarbons |
| D009930 | Organic Chemicals |
| Post-20 |
|
| Post-30 |
|
Repeated measure ANOVA group (pill) |
| 0.292 |
The threshold for significance was p<0.05 |
| Superiority |
Repeated measures ANOVA |
| ANOVA | Repeated measure ANOVA group x time | 0.609 | The threshold for significance was p<0.05 | Superiority | Repeated measures ANOVA |
| Post-20 |
|
| Post-30 |
|
Repeated measure ANOVA group (pill) |
| 0.323 |
The threshold for significance was p<0.05 |
| Superiority |
Repeated measures ANOVA |
| ANOVA | Repeated measure ANOVA group x time | 0.885 | The threshold for significance was p<0.05 | Superiority | Repeated measures ANOVA |
| Post-20 |
|
| Post-30 |
|
Repeated measure ANOVA group (pill) |
| 0.145 |
The threshold for significance was p<0.05 |
| Superiority |
Repeated measures ANOVA |
| ANOVA | Repeated measure ANOVA group x time | 0.230 | The threshold for significance was p<0.05 | Superiority | Repeated measures ANOVA |
| Post-20 |
|
| Post-30 |
|
Repeated measure ANOVA group (pill) |
| 0.939 |
The threshold for significance was p<0.05 |
| Superiority |
Repeated measures ANOVA |
| ANOVA | Repeated measure ANOVA group x time | 0.784 | The threshold for significance was p<0.05 | Superiority | Repeated measures ANOVA |
| Post-20 |
|
| Post-30 |
|
Repeated measure ANOVA group (pill) |
| 0.74 |
The threshold for significance was p<0.05 |
| Superiority |
Repeated measures ANOVA |
| ANOVA | Repeated measure ANOVA group x time | 0.703 | The threshold for significance was p<0.05 | Superiority | Repeated measures ANOVA |
| Post-20 |
|
| Post-30 |
|
Repeated measure ANOVA group (pill) |
| 0.358 |
The threshold for significance was p<0.05 |
| Superiority |
Repeated measures ANOVA |
| ANOVA | Repeated measure ANOVA group x time | 0.738 | The threshold for significance was p<0.05 | Superiority | Repeated measures ANOVA |
| Post-20 |
|
| Post-30 |
|
Repeated measure ANOVA group (pill) |
| 0.897 |
The threshold for significance was p<0.05 |
| Superiority |
Repeated measures ANOVA |
| ANOVA | Repeated measure ANOVA group x time | 0.595 | The threshold for significance was p<0.05 | Superiority | Repeated measures ANOVA |