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

• Status: Completed
• Trial end date: 2007-07-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Hadassah Medical Organization
• Collaborator: Stanley Medical Research Institute
• Treatments: Sertraline

Criteria

Inclusion Criteria:

1. 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.

2. Hamilton Depression Scale (HAM-D) total >16 with item 1 (depressed mood) >2.

3. Age 18-70 years, male or female.

4. Competent and willing to give written informed consent.

Exclusion Criteria:

1. No clinical hyper- or hypothyroidism nor other thyroid illness.

2. No neurological or other physical illness that may impact upon the study or limit prescription of the study medications.

3. No lifetime history of substance or alcohol dependence or of abuse in the preceding 12 months.

4. No significant suicidal risk (HAM-D item 3 (suicide) <3).