Bipolar/Unipolar: Double-Blind Evaluation of Triiodothyronine (T3, Cytomel) vs. Placebo as a Supplement to the Treatment of Bipolar Depression with a Mood Stabilizer and Sertraline (Zoloft) or as a Supplement to the Treatment of Unipolar Depression with Sertraline (Zoloft)

Contact name: Richard Bruno

Phone: (609)-921-6050

Fax: (609)-921-3620

Email: rabruno@gminstitutes.com

Disorder: Bipolar/Unipolar Depression

Geographic location: Princeton, NJ

Other keywords: bipolar depression depressed zoloft thyroid hormone

Participant compensation: 0.00

Time commitment required: 8 weeks

Drug trial: Yes

Recruitment end date (approximate): August 26, 2006

Study criteria (i.e., age or gender requirements):
Eligible patients are male or female, between the ages of 18 and 70.

Exclusion criteria:
Women must not be pregnant or lactating and must be using adequate contraceptives. Patient must not have been treated with sertraline during the current depressive episode or have a history of alcohol or substance abuse within the last 12 months or be lactose intolerant (as placebo contains lactose powder).

Brief description of study:
Many treated depression patients do not fully respond to treatment leaving nearly 40% significantly symptomatic. The purpose of this project will be to treat manic depressive and major depression patients with thyroid hormone in addition to sertraline, an FDA approved depression medication. Research has shown an association between thyroid function, depression and response to antidepressants. This study will assess the importance of T3 supplementation in Unipolar and Bipolar patients.
All clinical research visits, laboratory work, investigational medication, transportation and study related procedures are provided at no cost.

Additional information:
Other criteria will be discussed at a Screening Visit.