Schizophrenia
Conditions
Keywords
Weight loss, Support group, Exercise, Atomoxetine
Brief summary
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.
Detailed description
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.
Interventions
BEHAVIORALDiet support group
Diet support group weekly and exercise sessions 3 times/week, placebo medication
BEHAVIORALGroup counseling and exercise
Support group weekly and exercise sessions 3 times/week for 24 weeks
Sponsors
Eli Lilly and Company
University of Maryland, Baltimore
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Schizophrenia or schizoaffective Disorder * Taking olanzapine or clozapine for at least 6 months * Weight gain of 7% over baseline or BMI greater than or equal to 27
Exclusion criteria
* Current treatment with methylphenidate, clonidine, tricyclic antidepressants, bupropion and venlafaxine * Treatment with other medications known to cause weight gain unless weight stable on medication for 6 months * Current treatment with other medications for weight loss unless weight stable for 6 months * Mental Retardation * Alcohol or Substance Dependence within the last 6 months * Pregnancy * Alcohol or Substance Abuse within the lat month * Uncontrolled hypertension defined as a blood pressure exceeding 140/90 on three consecutive readings despite adequate treatment
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Weight | Weekly for 24 weeks | 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. |
Secondary
| Measure | Time frame |
|---|---|
| Chemistry Panel | baseline, 10 weeks and 24 weeks |
| 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 |
Countries
United States
Participant flow
Recruitment details
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.
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| Active Atomoxetine titrated up to 120 mg/day by week 8 and continues at 120 mg/day through week 24. | 20 |
| Placebo Placebo medication, diet support group weekly and exercise sessions 3 times/week | 17 |
| Total | 37 |
Baseline characteristics
| Characteristic | Placebo | Active | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 17 Participants | 20 Participants | 37 Participants |
| Age, Continuous | 46.1 years STANDARD_DEVIATION 9.4 | 47.8 years STANDARD_DEVIATION 8.4 | 46.9 years STANDARD_DEVIATION 8.8 |
| Region of Enrollment United States | 17 participants | 20 participants | 37 participants |
| Sex: Female, Male Female | 5 Participants | 6 Participants | 11 Participants |
| Sex: Female, Male Male | 12 Participants | 14 Participants | 26 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 5 / — | 4 / — |
| serious Total, serious adverse events | 2 / — | 1 / — |
Outcome results
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.
Time frame: Weekly for 24 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Active | Change From Baseline in Weight | 1.7 kilograms | Standard Deviation 1.4 |
| Placebo | Change From Baseline in Weight | 2.1 kilograms | Standard Deviation 1.4 |
Secondary
Chemistry Panel
Time frame: baseline, 10 weeks and 24 weeks
Secondary
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
Secondary
Vital Signs
Time frame: Weekly for 24 weeks