Sequential Tranylcypromine (TC), TC + Dextroamphetamine and TC + Triiodothyronine for Refractory Depression

• Status: Terminated
• Trial end date: 2006-08-01
• Target enrollment: 0
• Participant gender: All

Summary

This pilot study will assess the efficacy of several sequential pharmacological treatments for patients with Refractory Depression.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: New York State Psychiatric Institute
• Treatments: Dextroamphetamine; Tranylcypromine

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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