This pilot study will assess the efficacy of several sequential pharmacological treatments for patients with Refractory Depression.
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
31
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.
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.
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).
Depression Evaluation Service - New York State Psychiatric Institute
New York, New York, United States
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.
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