NCT00569517

Brief Summary

The purpose of this pilot study is to assess patient accessibility, interest and response in order to design an adequately powered study to compare brief, group cognitive behavioral therapy (CBT) for weight loss to usual care in non-demented patients above the age of 18 years old who are currently taking atypical antipsychotic medications. This pilot study is necessary, with current limitations of data in this area, to design an adequately powered study to address the difficulties managing metabolic syndrome risk factors in patients on antipsychotics.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
32

participants targeted

Target at P25-P50 for not_applicable obesity

Timeline
Completed

Started Jan 2008

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 5, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 7, 2007

Completed
25 days until next milestone

Study Start

First participant enrolled

January 1, 2008

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2008

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2009

Completed
Last Updated

March 20, 2009

Status Verified

March 1, 2009

Enrollment Period

11 months

First QC Date

December 5, 2007

Last Update Submit

March 19, 2009

Conditions

Obesity

Keywords

obesityCBTAtypical antipsychoticsmetabolic syndrome

Outcome Measures

Primary Outcomes (1)

  • The accessibility to overweight outpatients with stable psychotic or mood disorders, currently treated with atypical antipsychotics willing to participate in a research study involving CBT.

    3 months

Secondary Outcomes (1)

  • Measure outcome parameters; body mass index, total cholesterol, low-density lipoproteins, triglycerides, fasting blood sugar, waist circumference, blood pressure & pulse among patients receiving CBT treatment or usual care at baseline, 6 wks & 12 wks.

    3 months

Study Arms (2)

1

EXPERIMENTAL

6-CBT-sessions for weight loss

Behavioral: CBT

2

EXPERIMENTAL

Single educational intervention for weight

Other: educational

Interventions

CBTBEHAVIORAL

6-CBT based sesions

1
educationalOTHER

subjects receive one hour of nutrition education and 5 weekly phone calls

2

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age 18 years and above
  • Patients with diagnosis of schizophrenia, schizoaffective disorder or bipolar disorder determined by assessment with chart review, currently taking at least one atypical antipsychotic, started at least 2 months prior to randomization
  • Body Mass Index (BMI) greater than 30
  • ability to consent to treatment, determined by the patient's treating/referring physician

You may not qualify if:

  • Patients with premorbid medical problems that preclude involvement in a weight loss program
  • Active substance abuse or dependence, indicated by a positive urine drug screen in the last 3 months
  • Mini- Mental Status Exam (MMSE) less than 24
  • active psychosis or mania, determined by administration of the PANSS score greater than 3 on the following items; delusions, conceptual disorganization, hallucinatory behavior, blunted affect, social withdrawal, lack of spontaneity and conversation flow, mannerisms and posturing, and unusual thought content, and YMRS greater than 10, respectively
  • active major depressive episode, determined by administration of HAM-D greater than 13
  • patients taking any medications for weight loss or currently enrolled in a weight loss program
  • changes in medication regimen for diabetes or dyslipidemia within the last 3 months

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Michael E. DeBakey VA Medical Center (152)

Houston, Texas, 77030, United States

Location

MeSH Terms

Conditions

ObesityMetabolic Syndrome

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsInsulin ResistanceHyperinsulinismGlucose Metabolism DisordersMetabolic Diseases

Study Officials

  • Rayan Aljurdi, MD

    Michael E. DeBakey VA Medical Center (152)

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
FED

Study Record Dates

First Submitted

December 5, 2007

First Posted

December 7, 2007

Study Start

January 1, 2008

Primary Completion

December 1, 2008

Study Completion

March 1, 2009

Last Updated

March 20, 2009

Record last verified: 2009-03

Locations

US(1)