Sequential Tranylcypromine (TC), TC + Dextroamphetamine and TC + Triiodothyronine for Refractory Depression
This pilot study will assess the efficacy of several sequential pharmacological treatments for patients with Refractory Depression.
|Study Design:||Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Pilot Study of Treatment for Refractory Depression With Sequential Trials of Tranylcypromine, Tranylcypromine Plus Dextroamphetamine, Tranylcypromine Plus Triiodothyronine.|
- Hamilton Depression Scale (HAM-D) [ Time Frame: up to 10 mos. ] [ Designated as safety issue: No ]
- Beck Depression Inventory (BDI) [ Time Frame: up to 10 mos. ] [ Designated as safety issue: No ]
- Clinical Global Impression (CGI) [ Time Frame: up to 10 mos. ] [ Designated as safety issue: No ]
- Patient Global Impression (PGI) [ Time Frame: up to 10 mos. ] [ Designated as safety issue: No ]
|Study Start Date:||September 2001|
|Study Completion Date:||August 2006|
|Primary Completion Date:||August 2006 (Final data collection date for primary outcome measure)|
sequential tranylcypromine (TC) followed by TC + dextroamphetamine followed by TC + T3
standard dose:60 mg/d for a minimum of 8 weeks, a maximum of 17 weeks; high dose for non-remitters: up to 120 mg/day for a maximum of 9 weeks.
Other Name: ParnateDrug: Dextroamphetamine
up to 40 mg/day for 9 weeks, in combination with high dose of tranylcypromine for patients not remitting on the standard or high doses of tranylcypromine alone.
Other Name: DexedrineDrug: Triiodothyronine
For patients not remitting on higher dose of tranylcypromine plus dextroamphetamine: Up to 75 mg/day for 8 weeks(+/- dextroamphetamine) (max 8 weeks) in combination with highest does of tranylcypromine (up to 120mg/day).
Other Name: Cytomel
This pilot study will recruit 40 patients with Major Depression and a history of at least two failed prior adequate somatic treatments. In addition to usual physical work-up, all patients will have extensive thyroid testing, and then will receive standard dose Tranylcypromine (i.e., max. 60 mg/d). Non-remitters will have dose increased to max. 120 mg/d if tolerated. Non-remitters to high dose Tranylcypromine will then have Dextroamphetamine added with frequent blood pressure monitoring to max. 40 mg/d. Non-remitters will have Triiodothyronine added to the Tranylcypromine.
|United States, New York|
|Depression Evaluation Service - New York State Psychiatric Institute|
|New York, New York, United States, 10032|
|Principal Investigator:||Jonathan W. Stewart, MD||New York State Psychiatric Institute - Columbia University Department of Psychiatry|