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

Primary Purpose

Major Depression, Bipolar Disorder, Unipolar Depression

Status

Completed

Phase

Phase 3

Locations

International

Study Type

Interventional

Intervention

triiodothyronine

sertraline

About this trial

This is an interventional treatment trial for Major Depression focused on measuring major depression, bipolar disorder, unipolar depression, sertraline, triiodothyronine

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: 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. Exclusion Criteria: 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).

Sites / Locations

Global Medical Institutes
Hadassah Medical Organisation

Outcomes

Primary Outcome Measures

Response - HAM-D-21 improvement >50% at 8 weeks

Remission - final HAM-D-21 total <7 at 8 weeks

Secondary Outcome Measures

Rate of change in HAM-D-21 scores over 8 week treatment period

Full Information

NCT ID

NCT00158990

First Posted

September 8, 2005

Last Updated

January 2, 2007

Sponsor

Hadassah Medical Organization

Collaborators

Stanley Medical Research Institute

1. Study Identification

Unique Protocol Identification Number

NCT00158990

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

August 2005

Overall Recruitment Status

Completed

Study Start Date

October 2002 (undefined)

Primary Completion Date

undefined (undefined)

Study Completion Date

July 2007 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor

Hadassah Medical Organization

Collaborators

Stanley Medical Research Institute

4. Oversight

5. Study Description

Brief 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.

Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Major Depression, Bipolar Disorder, Unipolar Depression

Keywords

major depression, bipolar disorder, unipolar depression, sertraline, triiodothyronine

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

Double

Allocation

Randomized

Enrollment

220 (false)

8. Arms, Groups, and Interventions

Intervention Type

Drug

Intervention Name(s)

triiodothyronine

Intervention Type

Drug

Intervention Name(s)

sertraline

Primary Outcome Measure Information:

Title

Response - HAM-D-21 improvement >50% at 8 weeks

Title

Remission - final HAM-D-21 total <7 at 8 weeks

Secondary Outcome Measure Information:

Title

Rate of change in HAM-D-21 scores over 8 week treatment period

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

Eligibility Criteria

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Bernard Lerer, MD

Organizational Affiliation

Hadassah Medical Organization

Official's Role

Principal Investigator

Facility Information:

Facility Name

Global Medical Institutes

City

Princeton

State/Province

New Jersey

ZIP/Postal Code

08540

Country

United States

Facility Name

Hadassah Medical Organisation

City

Jerusalem

ZIP/Postal Code

91120

Country

Israel

12. IPD Sharing Statement

Citations:

PubMed Identifier

17548749

Citation

Cooper-Kazaz R, Apter JT, Cohen R, Karagichev L, Muhammed-Moussa S, Grupper D, Drori T, Newman ME, Sackeim HA, Glaser B, Lerer B. Combined treatment with sertraline and liothyronine in major depression: a randomized, double-blind, placebo-controlled trial. Arch Gen Psychiatry. 2007 Jun;64(6):679-88. doi: 10.1001/archpsyc.64.6.679.

Results Reference

derived

Learn more about this trial

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

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