Reducing the Weight of Overweight Schizophrenia Patients

NCT00158366 | Completed DMC

• 2 other identifiers: R01MH066068DSIR 83-ATAP
• Study Type: interventional
• Target: 261
• Locations: 1 country
• Sites: 1

Brief Summary

This study will determine the effectiveness of a group-based behavioral program for weight reduction in overweight and obese schizophrenia patients.

Conditions

Schizophrenia; Obesity

Keywords

Weight Loss

Outcome Measures

Primary Outcomes (1)

• Weight reduction

  Measured at Week 14 and Month 24

Secondary Outcomes (1)

• Weight maintenance

  Measured at Week 14 and Month 24

Study Arms (4)

1

EXPERIMENTAL

Phase 1 participants who will receive behavioral training for 14 weeks

Behavioral: Behavioral training

2

ACTIVE COMPARATOR

Phase 1 participants who will receive social skills training for 14 weeks

Behavioral: Social skills training

3

EXPERIMENTAL

Participants in the Phase 1 behavioral training group who have a 4% or more weight loss and will be enrolled in weekly behavioral training alone for 24 months in Phase 2

Behavioral: Behavioral training

4

EXPERIMENTAL

Participants in the Phase 1 behavioral training group who have a 4% or more weight loss and will be enrolled in weekly behavioral training plus biweekly booster treatments for 24 months in Phase 2

Behavioral: Behavioral training booster sessions

Interventions

Behavioral training BEHAVIORAL

The behavioral training will teach participants ways to control their diet and increase their physical activity.

1; 3

Social skills training BEHAVIORAL

The social skills training will teach participants how to indirectly control their weight by making social contacts and seeking social support.

2

Behavioral training booster sessions BEHAVIORAL

During biweekly booster treatment sessions, participants will discuss their response to different diet and exercise regimens, and researchers will discuss strategies for increasing one's success with the regimens.

4

Eligibility Criteria

• Age: 14 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Diagnosis of schizophrenia or schizoaffective disorder
• Body mass index (BMI) greater than 27
• Stable on antipsychotic drug regimen for at least 1 month prior to study entry
• Parent or guardian willing to provide informed consent, if applicable
• Positive and negative syndrome scale score less than 90
• Willing to use acceptable methods of contraception during the study

You may not qualify if:

• Medical contraindication for participating in a weight reduction/exercise program
• Mental retardation
• Current enrollment in another weight management program
• Current use of weight reduction medication
• Unstable cardiovascular or thyroid disease
• Active or end-stage renal disease
• Psychiatric hospitalization within 1 month prior to study entry
• Current use of more than one anti-psychotic medication
• Pregnancy or breastfeeding

Sponsors & Collaborators

• University of Pittsburgh: lead
• National Institute of Mental Health (NIMH): collaborator

Study Sites (1)

Western Psychiatric Institute and Clinic of University of Pennsylvania Medical Center

Pittsburgh, Pennsylvania, 15213, United States

Location

Related Publications (4)

• Brar JS, Ganguli R, Pandina G, Turkoz I, Berry S, Mahmoud R. Effects of behavioral therapy on weight loss in overweight and obese patients with schizophrenia or schizoaffective disorder. J Clin Psychiatry. 2005 Feb;66(2):205-12. doi: 10.4088/jcp.v66n0208.

  PMID: 15705006 BACKGROUND

• Ganguli R, Brar JS, Ayrton Z. Weight gain over 4 months in schizophrenia patients: a comparison of olanzapine and risperidone. Schizophr Res. 2001 Apr 30;49(3):261-7. doi: 10.1016/s0920-9964(00)00080-3.

  PMID: 11356587 BACKGROUND

• Ganguli R. Weight gain associated with antipsychotic drugs. J Clin Psychiatry. 1999;60 Suppl 21:20-4.

  PMID: 10548138 BACKGROUND

• Janney CA, Ganguli R, Richardson CR, Holleman RG, Tang G, Cauley JA, Kriska AM. Sedentary behavior and psychiatric symptoms in overweight and obese adults with schizophrenia and schizoaffective disorders (WAIST Study). Schizophr Res. 2013 Apr;145(1-3):63-8. doi: 10.1016/j.schres.2013.01.010. Epub 2013 Feb 12.

  PMID: 23410710 DERIVED

MeSH Terms

Conditions

Schizophrenia; Obesity; Weight Loss

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Body Weight Changes

Study Officials

• Rohan Ganguli, MD

  Western Psychiatric Institute and Clinic of University of Pennsylvania Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Psychiatry

Study Record Dates

• First Submitted: September 7, 2005
• First Posted: September 12, 2005
• Study Start: May 1, 2004
• Primary Completion: May 1, 2010
• Study Completion: July 1, 2018
• Last Updated: August 22, 2018

Record last verified: 2018-08

Locations

US (1)