Sequential Tranylcypromine (TC), TC + Dextroamphetamine and TC + Triiodothyronine for Refractory Depression
Stopped early · Phase 4
Conditions studied: Major Depression
In brief
This pilot study will assess the efficacy of several sequential pharmacological treatments for patients with Refractory Depression.
Key facts
- Study ID
- NCT00296686
- Run by
- New York State Psychiatric Institute
- People needed
- 31
- Starts
- 2001-09-01
- Expected to finish
- 2006-08-01
- Last updated by the study team
- 2012-04-27
Who can join
Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- Depression Evaluation Service - New York State Psychiatric Institute — New York, New York, United States
Full record on ClinicalTrials.gov
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