- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00158990
Triiodothyronine (T3) Supplementation in the Treatment of Bipolar and Unipolar Depression.
Triiodothyronine (T3) Supplementation in Bipolar and Unipolar Depression: A Random Assignment, Double Blind, Placebo-Controlled Study.
Study Overview
Status
Conditions
Intervention / Treatment
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
Enrollment
Phase
- Phase 3
Contacts and Locations
Study Locations
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Jerusalem, Israel, 91120
- Hadassah Medical Organisation
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New Jersey
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Princeton, New Jersey, United States, 08540
- Global Medical Institutes
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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).
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: DOUBLE
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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Response - HAM-D-21 improvement >50% at 8 weeks
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Remission - final HAM-D-21 total <7 at 8 weeks
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Secondary Outcome Measures
Outcome Measure |
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Rate of change in HAM-D-21 scores over 8 week treatment period
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Bernard Lerer, MD, Hadassah Medical Organization
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Study Completion
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ESTIMATE)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Behavioral Symptoms
- Mental Disorders
- Mood Disorders
- Bipolar and Related Disorders
- Depression
- Depressive Disorder
- Bipolar Disorder
- Depressive Disorder, Major
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Psychotropic Drugs
- Serotonin Uptake Inhibitors
- Neurotransmitter Uptake Inhibitors
- Membrane Transport Modulators
- Serotonin Agents
- Antidepressive Agents
- Sertraline
Other Study ID Numbers
- BPL-0100-HMO-CTIL
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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