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

Bipolar Disorder Clinical Trial

Official title:

Triiodothyronine (T3) Supplementation in Bipolar and Unipolar Depression: A Random Assignment, Double Blind, Placebo-Controlled Study.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00158990
• Other study ID #: BPL-0100-HMO-CTIL
• Status: Completed
• Phase: Phase 3
• First received: September 8, 2005
• Last updated: January 2, 2007
• Start date: October 2002
• Est. completion date: July 2007

Study information

• Verified date: August 2005
• Source: Hadassah Medical Organization
• Contact: n/a
• Is FDA regulated: No
• Health authority: Israel: Israeli Health Ministry Pharmaceutical Administration
• Study type: Interventional

Clinical Trial 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.

Description:

AIM: To determine the therapeutic efficacy and adverse effects of triiodothyronine (T3) as a supplement to the treatment of bipolar depression (BPD) with a mood stabilizer (MS) (lithium

• Li, valproic acid - VPA or carbamazepine - CBZ) and the specific serotonin reuptake inhibitor (SSRI), sertraline; and as a supplement to the treatment of unipolar depression (UPD) with sertraline.

METHOD: A random assignment, double blind, placebo-controlled trial separately evaluating patients with a) BPD who are treated with MS + sertraline + T3 or MS + sertraline + placebo and b) UPD who are treated with sertraline + T3 or sertraline + placebo, for up to 8 weeks in both cases. The design of the trial will permit both the outcome of treatment and the speed of response to be evaluated.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 220
• Est. completion date: July 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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).

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Bipolar Disorder
• Depression
• Depressive Disorder
• Depressive Disorder, Major
• Major Depression
• Unipolar Depression

Intervention

Drug:
• triiodothyronine

• sertraline

Locations

Country	Name	City	State
Israel	Hadassah Medical Organisation	Jerusalem
United States	Global Medical Institutes	Princeton	New Jersey

Sponsors (2)

Lead Sponsor	Collaborator
Hadassah Medical Organization	Stanley Medical Research Institute

Countries where clinical trial is conducted

United States,  Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Response - HAM-D-21 improvement >50% at 8 weeks
Primary	Remission - final HAM-D-21 total <7 at 8 weeks
Secondary	Rate of change in HAM-D-21 scores over 8 week treatment period