Treatment for Depressed, Obese Individuals at Risk for Cardiovascular Disease (CVD)

Obesity Clinical Trial

— TODI  

Official title:

Treatment of Obesity in Depressed Individuals: A Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01692574
• Other study ID #: 813829
• Status: Completed
• Phase: N/A
• First received: September 20, 2012
• Last updated: August 18, 2016
• Start date: August 2012
• Est. completion date: November 2015

Study information

• Verified date: August 2016
• Source: University of Pennsylvania
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Data and Safety Monitoring Board
• Study type: Interventional

Clinical Trial Summary

To determine whether individuals who suffer from depression and obesity are able to lose weight and show improvements in mood and cardiovascular disease risk factors following 20 weeks of a combined treatment of cognitive-behavior therapy for depression and behavior modification for weight loss. Participants will be assigned to one of three treatments: 1) cognitive-behavior therapy for the treatment of depression combined with an alternative approach to weight loss, 2) a weight loss intervention combined with a depression support and education , or 3) cognitive-behavioral therapy for depression combined with a weight loss intervention.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 76
• Est. completion date: November 2015
• Est. primary completion date: November 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria

• Female and male participants, with a BMI of 27 kg/m2 to 45 kg/m2

• Age 18 - 70 years old

• Presence of current major depressive disorder or dysthymic disorder

• At least 2 CVD risk factors, as characterized by the metabolic syndrome, including:

• Elevated waist circumference (males 40 inches or 102 cm; females 35 inches of 88 cm)

• Fasting blood glucose 100 mg/dL

• Blood pressure 130/85 mm Hg

• Triglycerides 150 mg/dL

• Reduced HDL cholesterol (males 40 mg/dL; females 50 mg/dL)

• OR medications for these conditions

• Able to comply will all study procedures and schedule

• Able to speak and read English

Exclusion Criteria

• Cardiovascular event (e.g., myocardial infarction, stroke) within the past 12 months

• Use of tricyclic anti-depressants, monoamine oxidase inhibitors or paroxetine, mood stabilizers, or antipsychotic medications. (Note: participants who take SSRI/SNRI may be acceptable, provided they have been on a stable dose of these medications 3 months.)

• Use of weight-loss medications or any medications known to significantly affect weight (e.g., oral steroids) in past 3 months

• Weight loss of 5% or more in past 6 months

• Enrollment in weight reduction program in prior 3 months

• Treatment in individual psychotherapy for any psychiatric disorder in prior 3 months (Note: participants in couples or family counseling will be allowed.)

• Severe depression or severe impairment of functioning as judged by the assessor or PI

• Presence of active suicidal ideation

• Diabetes

• Alcohol/drug abuse/dependence

• Renal/hepatic disease

• Change in thyroid medications in last 3 months

• Pregnant/lactating, within 6-months post-partum

• Current diagnoses, or history within the last 5 years, of anorexia or bulimia

• Psychotic symptoms or hospitalization for a psychiatric disorder in previous 12 months

• Mood disorder NOS, substance-induced mood disorders, mood disorders due to a general medical condition

• History of bipolar disorder

• History of head trauma

• Any changes in smoking behavior in prior 3 months (or plans to change in the next 3 months)

• Plans for bariatric surgery

• Any other uncontrolled major medical problems

• Women who are pregnant

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Factorial Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cardiovascular Disease
• Cardiovascular Diseases
• Depression
• Depressive Disorder
• Depressive Disorder, Major
• Disease
• Dysthymic Disorder
• Major Depressive Disorder
• Obesity

Intervention

Behavioral:
• Behavior Modification for Weight Loss

• Alternative Approach to Weight Loss

• Cognitive-Behavior Therapy for Depression

• Depression Support and Education

Locations

Country	Name	City	State
United States	University of Pennsylvania: Center for Weight and Eating Disorders	Philadelphia	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
University of Pennsylvania	National Heart, Lung, and Blood Institute (NHLBI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Changes in mood		Baseline to 20 weeks of treatment, follow up at week 46	No
Primary	Weight loss	To determine whether depressed, obese individuals who receive the combined treatment of cognitive-behavior therapy for depression and behavior modification for weight loss are able to lose 5% of their initial weight at the end of 20 weeks of treatment.	Baseline to 20 weeks of treatment, follow-up at week 46	No
Secondary	Changes in metabolic cardiovascular disease risk factors and inflammatory markers		Baseline to 20 weeks of treatment, follow up at week 46	No