Sequential Tranylcypromine (TC), TC + Dextroamphetamine and TC + Triiodothyronine for Refractory Depression
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|ClinicalTrials.gov Identifier: NCT00296686|
Recruitment Status : Terminated (Study is no longer funded.)
First Posted : February 27, 2006
Last Update Posted : April 27, 2012
|Condition or disease||Intervention/treatment||Phase|
|Major Depression||Drug: Tranylcypromine Drug: Dextroamphetamine Drug: Triiodothyronine||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||31 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Pilot Study of Treatment for Refractory Depression With Sequential Trials of Tranylcypromine, Tranylcypromine Plus Dextroamphetamine, Tranylcypromine Plus Triiodothyronine.|
|Study Start Date :||September 2001|
|Primary Completion Date :||August 2006|
|Study Completion Date :||August 2006|
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
- Hamilton Depression Scale (HAM-D) [ Time Frame: up to 10 mos. ]
- Beck Depression Inventory (BDI) [ Time Frame: up to 10 mos. ]
- Clinical Global Impression (CGI) [ Time Frame: up to 10 mos. ]
- Patient Global Impression (PGI) [ Time Frame: up to 10 mos. ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00296686
|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|