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| ID | Type | Description | Link |
|---|---|---|---|
| F1D-US-X254 |
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| Name | Class |
|---|---|
| Eli Lilly and Company | INDUSTRY |
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The study investigates the use of Atomoxetine in combination with exercise and a diet support group (Weight Watchers)to treat weight gain associated with Olanzapine or clozapine. All patients must be adults who have been diagnosed with Schizophrenia or Schizoaffective Disorder.
The study is a 6 month double-blind trial of atomoxetine in combination with a Weight Watchers group to help patients lose the weight they have gained taking olanzapine or clozapine. All participants should have been on Olanzapine or clozapine for at least 6 months and gained 7% of baseline weight or have a BMI of 27 or greater. In addition to the group support, participants are provided supervised exercise sessions and medical supervision. Previous studies of the group process alone were successful in helping patients lose weight. It is hoped that the addition of atomoxetine, which is known to cause appetite suppression, will be more effective in helping subjects lose weight. All subjects will receive either atomoxetine or placebo during the 6 month study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| active | Active Comparator | Atomoxetine titrated up to 120 mg/day by week 8 and continues at 120 mg/day through week 24. Diet support group, group counseling and exercise. |
|
| Placebo | Placebo Comparator | Placebo medication, diet support group, group counseling and exercise |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Diet support group | Behavioral | Diet support group weekly and exercise sessions 3 times/week, placebo medication |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Weight | Weight loss was measured each week over the 24 week study period. Intent to treat analyses of treatment effects on the primary outcome (weight) were conducted using all observed weight measurements from all participants with post-baseline weight measurements, using the mixed model for unbalanced repeated measures ANOVA. This model summarizes change in weight for each participant by the average change in weight per week (slope) over 24 weeks, and compares these slopes between the two groups. | Weekly for 24 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Secondary Outcomes Are Improvement in Cognitive Impairments, Since Atomoxetine is Used for Treatment of ADHD and is Known to Improve Cognitive Function. | 24 weeks | |
| Vital Signs | Weekly for 24 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| M Patricia Ball, R.N.,C.,M.S. | University of Maryland Baltimore Maryland Psychiatric Research Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Maryland Psychiatric Research Center | Catonsville | Maryland | 21228 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21459735 | Result | Ball MP, Warren KR, Feldman S, McMahon RP, Kelly DL, Buchanan RW. Placebo-controlled trial of atomoxetine for weight reduction in people with schizophrenia treated with clozapine or olanzapine. Clin Schizophr Relat Psychoses. 2011 Apr;5(1):17-25. |
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There was a 2-week evaluation period during which time a diet and exercise program was implemented. All participants then began the double-blind treatment phase of the study. No participants were excluded unless the were taking an excluded medication. 40 participants were enrolled into active participation; 37 participants started treatment.
Recruitment took place from 2004 until March, 2008. Participants were recruited from the Maryland Psychiatric Research Center Outpatient Research Program and local community mental health centers.
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| ID | Title | Description |
|---|---|---|
| FG000 | Active | Atomoxetine titrated up to 120 mg/day by week 8 and continues at 120 mg/day through week 24. |
| FG001 | Placebo | Placebo medication, diet support group weekly and exercise sessions 3 times/week |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Active | Atomoxetine titrated up to 120 mg/day by week 8 and continues at 120 mg/day through week 24. |
| BG001 | Placebo | Placebo medication, diet support group weekly and exercise sessions 3 times/week |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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 | Change From Baseline in Weight | Weight loss was measured each week over the 24 week study period. Intent to treat analyses of treatment effects on the primary outcome (weight) were conducted using all observed weight measurements from all participants with post-baseline weight measurements, using the mixed model for unbalanced repeated measures ANOVA. This model summarizes change in weight for each participant by the average change in weight per week (slope) over 24 weeks, and compares these slopes between the two groups. | Posted | Mean | Standard Deviation | kilograms | Weekly for 24 weeks |
|
6 months
Weekly questionnaire assessing potential side effects
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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 | Active | Atomoxetine titrated up to 120 mg/day by week 8 and continues at 120 mg/day through week 24. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hypotension | Cardiac disorders | MedDRA | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Dizziness | Vascular disorders | MedDRA (10.0) | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| M. Patricia Ball, R.N., C.,M.S. | Maryland Psychiatric Research Center | 410-402-7663 | pball@mprc.umaryland.edu |
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| ID | Term |
|---|---|
| D012559 | Schizophrenia |
| D015431 | Weight Loss |
| D009043 | Motor Activity |
| ID | Term |
|---|---|
| D019967 | Schizophrenia Spectrum and Other Psychotic Disorders |
| D001523 | Mental Disorders |
| D001836 | Body Weight Changes |
| D001835 | Body Weight |
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| ID | Term |
|---|---|
| D015444 | Exercise |
| ID | Term |
|---|---|
| D009043 | Motor Activity |
| D009068 | Movement |
| D009142 | Musculoskeletal Physiological Phenomena |
| D055687 | Musculoskeletal and Neural Physiological Phenomena |
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| Group counseling and exercise | Behavioral | Support group weekly and exercise sessions 3 times/week for 24 weeks |
|
| Chemistry Panel | baseline, 10 weeks and 24 weeks |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
Placebo medication, diet support group weekly and exercise sessions 3 times/week
|
|
| Secondary | Secondary Outcomes Are Improvement in Cognitive Impairments, Since Atomoxetine is Used for Treatment of ADHD and is Known to Improve Cognitive Function. | Not Posted | 24 weeks | Participants |
| Secondary | Vital Signs | Not Posted | Weekly for 24 weeks | Participants |
| Secondary | Chemistry Panel | Not Posted | baseline, 10 weeks and 24 weeks | Participants |
| 2 |
| 5 |
| EG001 | Placebo | Placebo medication, diet support group weekly and exercise sessions 3 times/week | 1 | 4 |
| Extreme Sedation | General disorders | MedDRA (10.0) | Non-systematic Assessment |
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| Chest Pain | Cardiac disorders | MedDRA (10.0) | Non-systematic Assessment |
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| Slurred speech | Nervous system disorders | MedDRA (10.0) | Non-systematic Assessment |
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| Abnormal ECG | Cardiac disorders | MedDRA (10.0) | Systematic Assessment |
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| Hypotension | Cardiac disorders | MedDRA (10.0) | Systematic Assessment |
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| Nervousness | Psychiatric disorders | MedDRA (10.0) | Systematic Assessment |
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| Hypertension | Cardiac disorders | MedDRA (10.0) | Systematic Assessment |
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| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA (10.0) | Systematic Assessment |
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| Abnormal SGOT and SGPT | Blood and lymphatic system disorders | MedDRA (10.0) | Systematic Assessment |
|
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| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001519 | Behavior |