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

This study has been completed.
Sponsor:
Collaborator:
Stanley Medical Research Institute
Information provided by:
Hadassah Medical Organization
ClinicalTrials.gov Identifier:
NCT00158990
First received: September 8, 2005
Last updated: January 2, 2007
Last verified: August 2005
History of Changes
  Purpose

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.


Condition Intervention Phase
Major Depression
Bipolar Disorder
Unipolar Depression
 Drug: triiodothyronine
Drug: sertraline
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: Triiodothyronine (T3) Supplementation in Bipolar and Unipolar Depression: A Random Assignment, Double Blind, Placebo-Controlled Study.

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Hadassah Medical Organization:

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

Estimated Enrollment: 220
Study Start Date: October 2002
Estimated Study Completion Date: July 2007
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.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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).
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00158990

Locations
United States, New Jersey
Global Medical Institutes
Princeton, New Jersey, United States, 08540
Israel
Hadassah Medical Organisation
Jerusalem, Israel, 91120
Sponsors and Collaborators
Hadassah Medical Organization
Stanley Medical Research Institute
Investigators
Principal Investigator: Bernard Lerer, MD Hadassah - Medical Organisation
  More Information

No publications provided by Hadassah Medical Organization

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

ClinicalTrials.gov Identifier: NCT00158990     History of Changes
Other Study ID Numbers: BPL-0100-HMO-CTIL
Study First Received: September 8, 2005
Last Updated: January 2, 2007
Health Authority: Israel: Israeli Health Ministry Pharmaceutical Administration

Keywords provided by Hadassah Medical Organization:
major depression
bipolar disorder
unipolar depression
sertraline
triiodothyronine

Additional relevant MeSH terms:
Bipolar Disorder
Depression
Depressive Disorder
Depressive Disorder, Major
Affective Disorders, Psychotic
Mood Disorders
Mental Disorders
Behavioral Symptoms
Sertraline
Antidepressive Agents
 Psychotropic Drugs
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Serotonin Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on June 17, 2013