Status:
COMPLETED
Triiodothyronine (T3) Supplementation in the Treatment of Bipolar and Unipolar Depression.
Lead Sponsor:
Hadassah Medical Organization
Collaborating Sponsors:
Stanley Medical Research Institute
Conditions:
Major Depression
Bipolar Disorder
Eligibility:
All Genders
18-70 years
Phase:
PHASE3
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/...
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...
Eligibility Criteria
Inclusion
- 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
- 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).
Key Trial Info
Start Date :
October 1 2002
Trial Type :
INTERVENTIONAL
End Date :
July 1 2007
Estimated Enrollment :
220 Patients enrolled
Trial Details
Trial ID
NCT00158990
Start Date
October 1 2002
End Date
July 1 2007
Last Update
January 4 2007
Active Locations (2)
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1
Global Medical Institutes
Princeton, New Jersey, United States, 08540
2
Hadassah Medical Organisation
Jerusalem, Israel, 91120