Status:
TERMINATED
Sequential Tranylcypromine (TC), TC + Dextroamphetamine and TC + Triiodothyronine for Refractory Depression
Lead Sponsor:
New York State Psychiatric Institute
Conditions:
Major Depression
Eligibility:
All Genders
18-65 years
Phase:
PHASE4
Brief Summary
This pilot study will assess the efficacy of several sequential pharmacological treatments for patients with Refractory Depression.
Detailed Description
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 ex...
Eligibility Criteria
Inclusion
- Ages between 18-65
- Major Depression
- At least two prior ineffective antidepressant trials (at least 2 different mechanisms) or 1 inadequate ECT trial (at least 8 bilateral treatments)
- Physically healthy
Exclusion
- Known Tranylcypromine allergy
- Unable to follow tyramine-free diet
- Known allergy, intolerance or prior addiction to any stimulant would preclude patient's inclusion in the Dextroamphetamine portion of the protocol
- Current substance use disorder including alcohol)(past six months); ever dependent on stimulants would preclude Dextroamphetamine portion of the protocol
- Unable or unwilling to discontinue antidepressants including OTC antidepressants such as St. John's Wort
- History of psychosis, such as schizophrenia or psychotic depression; history of bipolar mania will be allowed if on adequate mood stabilizer
- Suicidal ideation/activity that makes outpatient treatment unsafe, unless protocol can be conducted as inpatient
- Current systolic BP \> 149 or diastolic BP \> 89 mm Hg (two readings); adequately treated hypertension is acceptable
- Evidence of hypo- or hyperthyroidism
- Pregnancy, lactation, refusal to use adequate birth control
Key Trial Info
Start Date :
September 1 2001
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2006
Estimated Enrollment :
31 Patients enrolled
Trial Details
Trial ID
NCT00296686
Start Date
September 1 2001
End Date
August 1 2006
Last Update
April 27 2012
Active Locations (1)
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1
Depression Evaluation Service - New York State Psychiatric Institute
New York, New York, United States, 10032