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

NCT ID: NCT00158990

Last Updated: 2007-01-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 220 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2002-10-31
• Study Completion Date: 2007-07-31

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.

Conditions

Major Depression; Bipolar Disorder; Unipolar Depression

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Interventions

triiodothyronine

Intervention Type: DRUG

sertraline

Intervention Type: DRUG

Eligibility 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).

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Stanley Medical Research Institute

OTHER

Sponsor Role: collaborator

Hadassah Medical Organization

OTHER

Sponsor Role: lead

Principal Investigators

Bernard Lerer, MD

Role: PRINCIPAL_INVESTIGATOR

Hadassah Medical Organization

Locations

Global Medical Institutes

Princeton, New Jersey, United States

Hadassah Medical Organisation

Jerusalem, , Israel

Countries

United States; Israel

References

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.

Reference Type: DERIVED

PMID: 17548749 (View on PubMed)

Other Identifiers

BPL-0100-HMO-CTIL

Identifier Type: -

Identifier Source: org_study_id