Condition(s) treated: Schizophrenia; Schizo-Affective Disorder; Obesity; Cardiovascular Disease

Intervention: Behavioral Treatment for Weight Reduction (Behavior)

Enrollment status: Recruiting. Expecting to enroll 300 people.

Sponsor: University of Pittsburgh

Principal investigator(s) or official(s):
Rohan Ganguli, MD, Principal Investigator, Affiliation: Univeristy Of Pittsburgh

Overall contact:
Georgia Murphy, MEd, Phone: 412 246-6718, Email: murphyga@upmc.edu

The purpose of this study is to find out if behavioral treatment can help overweight and obese subjects with schizophrenia or schizo-affective disorder to lose weight.

Official title: A Clinical Trail of Weight Reduction in Schizophrenia

Study design: Interventional, Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study

Primary outcome: Weight Loss at week 7 and week 14.; Long Term Maintenance of Weight Loss 12 and 24 months

Secondary outcome: BP,Fasting glucose,serum lipids:Baseline, week 14 Phase I.; BP,Fasting glucose, serum lipids:Baseline,12,24month Ph II.; Graded Exercise Test Baseline, Week 14.

Detailed description: This is a randomized parallel group, clinical trial in 300 overweight/obese schizophrenia patients to rigorously assess the effectiveness of a Behavioral Treatment(BT) for weight loss. The experimental treatment will be compared to social skills training(ST), as well as treatment as usual(UC). The BT and SST groups will receive behavioral interventions for weight reduction and social skills training respectively over a 14 week period (Phase I. Immediately following these interventions, patients in the BT group who achieve 4% or higher weight loss will be enrolled in a 24 month study examining the effectiveness of a maintenance treatment aimed at preventing weight re-gain(Phase II). In this phase, patients will be randomly assigned (2: 1) to either receive booster treatments one every 2 weeks, or treatment as usual over a 2 year duration. This is the first attempt ever to conduct a large randomized trial of an intervention for weight reduction, and maintenance of weight loss in schizophrenia.

Minimum eligible age: 14 Years. Maximum eligible age: 60 Years. Eligible gender(s): Both.

Criteria:

Inclusion Criteria:

- Males and Females between the ages of 14-60 yrs.

- Diagnosis of Schizophrenia or Schizoaffective disorder.

- BMI greater than 27kg/m2 at time of enrollment.

- Ability to provide informed consent.

- Have spontaneously expressed a desire to lose weight.

- Currently being treated with at least one antipsychotic medication.

- A PANSS score below 90 at time of enrollment.

- No psychiatric hospitalization within the past 1 month.

- Stable medication dosage regime for at least 1 month prior to enrollment.

- No medical contraindication for participating in a weight reduction/exercise program.

- Female patients of childbearing age must use an acceptable form of contraception.

Exclusion Criteria:

- Inability to provide informed consent.

- Moderate mental retardation.

- Currently enrolled in another weight management program.

- Currently being treated with a medication for weight reduction.

- Patients with unstable or active cardiovascular illness (MI), active or end-stage renal disease, unstable thyroid disease, etc.

- Female patients who are breastfeeding.

Georgia Murphy, MEd, Phone: 412 246-6718, Email: murphyga@upmc.edu

Western Psychiatric Institute and Clinic, Pittsburgh, Pennsylvania 15213, United States; Recruiting
David Kupfer, MD, Phone: 412-246-6777, Email: kupferdj@upmc.edu
Rohan Ganguli, MD, Principal Investigator
Jaspreet Brar, MD, Sub-Investigator

This website provides descriptions of our group's various research studies.

Start date: May 2004
End date: April 2009
Last updated: October 13, 2006