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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00158990
Recruitment Status : Completed
First Posted : September 12, 2005
Last Update Posted : January 4, 2007
Stanley Medical Research Institute
Information provided by:
Hadassah Medical Organization

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.

Condition or disease Intervention/treatment Phase
Major Depression Bipolar Disorder Unipolar Depression Drug: triiodothyronine Drug: sertraline Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Enrollment : 220 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: Triiodothyronine (T3) Supplementation in Bipolar and Unipolar Depression: A Random Assignment, Double Blind, Placebo-Controlled Study.
Study Start Date : October 2002
Study Completion Date : July 2007

Resource links provided by the National Library of Medicine

Primary Outcome Measures :
  1. Response - HAM-D-21 improvement >50% at 8 weeks
  2. Remission - final HAM-D-21 total <7 at 8 weeks

Secondary Outcome Measures :
  1. Rate of change in HAM-D-21 scores over 8 week treatment period

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00158990

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United States, New Jersey
Global Medical Institutes
Princeton, New Jersey, United States, 08540
Hadassah Medical Organisation
Jerusalem, Israel, 91120
Sponsors and Collaborators
Hadassah Medical Organization
Stanley Medical Research Institute
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Principal Investigator: Bernard Lerer, MD hadassah medical organisation
Publications automatically indexed to this study by Identifier (NCT Number):
Layout table for additonal information Identifier: NCT00158990    
Other Study ID Numbers: BPL-0100-HMO-CTIL
First Posted: September 12, 2005    Key Record Dates
Last Update Posted: January 4, 2007
Last Verified: August 2005
Keywords provided by Hadassah Medical Organization:
major depression
bipolar disorder
unipolar depression
Additional relevant MeSH terms:
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Depressive Disorder
Bipolar Disorder
Depressive Disorder, Major
Behavioral Symptoms
Mood Disorders
Mental Disorders
Bipolar and Related Disorders
Antidepressive Agents
Psychotropic Drugs
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Serotonin Agents
Physiological Effects of Drugs