Liothyronine (T3) for Bipolar Depression

NCT00790738 | Completed Phase 3 Results DMC

• 1 other identifier: 08-001
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 1

Brief Summary

This study evaluates the efficacy of the thyroid hormone T3 for depression in patients with bipolar disorder. In this study patients will be randomized to receive T3 or placebo.

Conditions

Depression; Bipolar Disorder

Keywords

bipolar disorder; depression; treatment; randomized controlled trial

Outcome Measures

Primary Outcomes (1)

• Hamilton Rating Scale for Depression Scores

  The Hamilton Rating Scale for Depression (HRSD) is a checklist of items ranked from 0-4 or 0-2, that was designed to measure the severity of depressive symptoms. The scale ranges from 0 to 50, and the following thresholds are used: very severe \>23, severe 19-22, moderate 14-18, mild 8-13 and normal ≤7.

  8 weeks

Secondary Outcomes (2)

• Clinician-Administered Rating Scale for Mania

  8 weeks

• Clinical Global Impression Scores

  8 weeks

Study Arms (2)

1

EXPERIMENTAL

liothyronine (T3)

Drug: Liothyronine (T3)

2

PLACEBO COMPARATOR

placebo

Drug: placebo

Interventions

Liothyronine (T3) DRUG

liothyronine (T3) up to 50 micrograms a day

Also known as: cytomel (liothyronine)

1

placebo DRUG

placebo

2

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18-65;
• DSM-IV diagnosis of BP I or BP II as per SCID;
• Currently presenting with at least moderate levels of depression (HAM-D \> 15;
• Patient has to be on stable dose of at least one mood stabilizer (lithium, valproate, carbamazepine, lamotrigine, second generation antipsychotics) for at least 4 weeks as per history;
• Antidepressants and/or additional mood stabilizers are allowed, but dose should be stable for at least 2 weeks;

You may not qualify if:

• Evidence of acute mania or hypomania (as measured by CARS-M \> 7);
• Abnormal (outside of lab normal range) thyroid function tests;
• Current thyroid hormone treatment;
• Any medical condition considered a contraindication for treatment with T3 (i.e. history of myocardial infarction, cardiac arrhythmia, severe cardiac insufficiency, Autoimmune Thyroid Disease /Hashimoto's Thyroiditis as determined by anti-thyroid antibody testing, previous or current thyroid adenoma, hyperthyroidism);
• EKG showing rhythm other than sinus or repolarization phase abnormalities;
• Current alcohol or substance abuse or dependence in past month as per SCID;
• Score of 3 or more on the suicide item of the HAM-D;
• Females who are pregnant, breastfeeding, or of childbearing age and not using adequate birth control.

Sponsors & Collaborators

• Northwell Health: lead
• National Alliance for Research on Schizophrenia and Depression: collaborator

Study Sites (1)

The Zucker Hillside Hospital

Glen Oaks, New York, 11004, United States

Location

MeSH Terms

Conditions

Depression; Bipolar Disorder

Interventions

Triiodothyronine

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Bipolar and Related Disorders; Mood Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Thyronines; Thyroid Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Thyroxine; Amino Acids, Aromatic; Amino Acids, Cyclic; Amino Acids; Amino Acids, Peptides, and Proteins

Limitations and Caveats

Despite several changes made in order to enhance recruitment during the study period, the study was markedly underpowered. Therefore, no definitive conclusions could be drawn from the data.

Results Point of Contact

• Title: Raphael J. Braga, MD
• Organization: The Zucker Hillside Hospital

rbraga@nshs.edu

718-4708060

Study Officials

• Raphael J Braga, MD

  The Zucker Hillside Hospital, North Shore - LIJHS

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: November 10, 2008
• First Posted: November 13, 2008
• Study Start: July 1, 2008
• Primary Completion: July 1, 2012
• Study Completion: July 1, 2012
• Last Updated: July 2, 2015
• Results First Posted: July 2, 2015

Record last verified: 2015-06

Locations

US (1)