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

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ClinicalTrials.gov Identifier: NCT00158990
Recruitment Status : Completed
First Posted : September 12, 2005
Last Update Posted : January 4, 2007
Sponsor:
Collaborator:
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.


Study Type : Interventional  (Clinical Trial)
Estimated 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
Estimated Study Completion Date : July 2007

Resource links provided by the National Library of Medicine

U.S. FDA Resources




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, Senior)
Sexes Eligible for Study:   All
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).

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 ClinicalTrials.gov identifier (NCT number): 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

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
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
sertraline
triiodothyronine

Additional relevant MeSH terms:
Depression
Depressive Disorder
Bipolar Disorder
Depressive Disorder, Major
Behavioral Symptoms
Mood Disorders
Mental Disorders
Bipolar and Related Disorders
Sertraline
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