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



Status:Recruiting
Conditions:Depression, Obesity Weight Loss, Peripheral Vascular Disease, Major Depression Disorder (MDD), Endocrine
Therapuetic Areas:Cardiology / Vascular Diseases, Endocrinology, Psychiatry / Psychology, Pulmonary / Respiratory Diseases
Healthy:No
Age Range:18 - 70
Updated:4/2/2016
Start Date:August 2012
Contact:Lucy F Hemsley-Faulconbridge, PhD
Email:lucyhf@mail.med.upenn.edu
Phone:215-746-7191

Use our guide to learn which trials are right for you!

Trial Summary
Trial Overview
Inclusion Criteria

Treatment of Obesity in Depressed Individuals: A Randomized Controlled Trial

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.


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
We found this trial at
1
site
University of Pennsylvania Center for Weight and Eating Disorders
Philadelphia, Pennsylvania 19104
?
mi
from
Philadelphia, PA
Click here to add this to my saved trials