Triiodothyronine (T3) Supplementation in the Treatment of Bipolar and Unipolar Depression.

Completed · Phase 3

Conditions studied: Major Depression, Bipolar Disorder, Unipolar Depression

In brief

The purpose of this project is to determine whether concurrent treatment of patients with major depression (unipolar or bipolar) with triiodothyronine (T3) and sertraline, will lead to a stronger and/or more rapid antidepressant effect than treatment with sertraline alone.

Key facts

Study ID

NCT00158990

Run by

Hadassah Medical Organization

People needed

220

Starts

2002-10-01

Expected to finish

2007-07-01

Last updated by the study team

2007-01-04

Who can join

Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Diagnosis of Major Depressive Episode (MDE) in the context of Bipolar Disorder I or II (BPD-I or BPD-II) or Major Depressive Disorder (UPD), according to DSM-IV criteria, without psychotic features.
• Hamilton Depression Scale (HAM-D) total >16 with item 1 (depressed mood) >2.
• Age 18-70 years, male or female.
• Competent and willing to give written informed consent.

You may not qualify if…

• No clinical hyper- or hypothyroidism nor other thyroid illness.
• No neurological or other physical illness that may impact upon the study or limit prescription of the study medications.
• No lifetime history of substance or alcohol dependence or of abuse in the preceding 12 months.
• No significant suicidal risk (HAM-D item 3 (suicide) <3).

Where it is running

• Global Medical Institutes — Princeton, New Jersey, United States
• Hadassah Medical Organisation — Jerusalem, Israel

Full record on ClinicalTrials.gov

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