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Completed

NCT Number: NCT00158990

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

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.

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Key information

Conditions

Major Depression Bipolar Disorder Bipolar and Related Disorders Depressive Disorder Depressive Disorder, Major Mental Disorders Mood Disorders Unipolar Depression

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Hadassah Medical Organisation, Jerusalem, Israel

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Triiodothyronine

Drug

Sertraline

Drug

Primary outcomes

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

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

Secondary outcomes

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

Sponsors and collaborators

Lead sponsor

Hadassah Medical Organization

Other

Collaborators

  • Stanley Medical Research Institute

Registry information

Official study title

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

Important dates

Study start
2002
Study completion
2007
First posted
Sep 12, 2005
Registry last updated
Jan 4, 2007

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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