A Phase 4 interventional study of Diet support group and Group counseling and exercise in Schizophrenia, sponsored by University of Maryland, Baltimore. Completed at 1 site in United States. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2022-03-14.
Sponsored by University of Maryland, Baltimore · Phase 4, Interventional, and Treatment
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.
3,471 studies on the registry are indexed under Schizophrenia; 472 are open to participants now.
This study's enrollment of 40 is below the median of 70 across 2,872 interventional studies indexed under Schizophrenia.
Browse Schizophrenia studies →University of Maryland, Baltimore is the lead sponsor of 687 studies on the registry; 130 are open to participants now.
Of its 90 completed or terminated interventional studies of FDA-regulated products, 63 (70%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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.
Behavioral: Group counseling and exercise
Placebo medication, diet support group, group counseling and exercise
Behavioral: Diet support group
Diet support group weekly and exercise sessions 3 times/week, placebo medication
Support group weekly and exercise sessions 3 times/week for 24 weeks
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.
Time frame: Weekly for 24 weeks
Secondary Outcomes Are Improvement in Cognitive Impairments, Since Atomoxetine is Used for Treatment of ADHD and is Known to Improve Cognitive Function.
Time frame: 24 weeks
Vital Signs
Time frame: Weekly for 24 weeks
Chemistry Panel
Time frame: baseline, 10 weeks and 24 weeks
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.
| Milestone | Active | Placebo |
|---|---|---|
| Started | 20 | 17 |
| Completed | 14 | 12 |
| Not completed | 6 | 5 |
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.
| kilograms | Active | Placebo |
|---|---|---|
| Change From Baseline in Weight | 1.7 ± 1.4 | 2.1 ± 1.4 |
Results for this outcome have not been posted.
Results for this outcome have not been posted.
Results for this outcome have not been posted.
Collected over 6 months. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Active | — | — | — |
| Placebo | — | — | — |
| Event | Active | Placebo |
|---|---|---|
| Chest PainCardiac disorders | 0/20 | 1/17 |
| HypotensionCardiac disorders | 1/20 | 0/17 |
| Extreme SedationGeneral disorders | 1/20 | 0/17 |
| Event | Active | Placebo |
|---|---|---|
| HypertensionCardiac disorders | 0/20 | 1/17 |
| CoughRespiratory, thoracic and mediastinal disorders | 0/20 | 1/17 |
| Abnormal SGOT and SGPTBlood and lymphatic system disorders | 0/20 | 1/17 |
| DizzinessVascular disorders | 1/20 | 0/17 |
| Slurred speechNervous system disorders | 1/20 | 0/17 |
| Abnormal ECGCardiac disorders | 1/20 | 0/17 |
| HypotensionCardiac disorders | 1/20 | 0/17 |
| NervousnessPsychiatric disorders | 1/20 | 0/17 |
| Age, Categorical(Participants) | Active | Placebo | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 20 | 17 | 37 |
| >=65 years | 0 | 0 | 0 |
| Age, Continuous(years) | Active | Placebo | Total |
|---|---|---|---|
| Mean | 47.8 ± 8.4 | 46.1 ± 9.4 | 46.9 ± 8.8 |
| Sex: Female, Male(Participants) | Active | Placebo | Total |
|---|---|---|---|
| Female | 6 | 5 | 11 |
| Male | 14 | 12 | 26 |
| Region of Enrollment(participants) | Active | Placebo | Total |
|---|---|---|---|
| United States | 20 | 17 | 37 |
This study is completed, as verified in Mar 2022. You cannot join it, but the record below documents what was studied.
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University of Maryland, Baltimore