Sequential Tranylcypromine (TC), TC + Dextroamphetamine and TC + Triiodothyronine for Refractory Depression
Information source: New York State Psychiatric Institute
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Major Depression
Intervention: Tranylcypromine (Drug); Dextroamphetamine (Drug); Triiodothyronine (Drug)
Phase: Phase 4
Status: Terminated
Sponsored by: New York State Psychiatric Institute Official(s) and/or principal investigator(s):
Jonathan W. Stewart, MD, Principal Investigator, Affiliation: New York State Psychiatric Institute - Columbia University Department of Psychiatry
Summary
This pilot study will assess the efficacy of several sequential pharmacological treatments
for patients with Refractory Depression.
Clinical Details
Official title: A Pilot Study of Treatment for Refractory Depression With Sequential Trials of Tranylcypromine, Tranylcypromine Plus Dextroamphetamine, Tranylcypromine Plus Triiodothyronine.
Study design: Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Hamilton Depression Scale (HAM-D)
Secondary outcome: Beck Depression Inventory (BDI)Clinical Global Impression (CGI) Patient Global Impression (PGI)
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 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.
Eligibility
Minimum age: 18 Years.
Maximum age: 65 Years.
Gender(s): Both.
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
Locations and Contacts
Depression Evaluation Service - New York State Psychiatric Institute, New York, New York 10032, United States
Additional Information
Depression Evaluation Service - official website New York State Psychiatric Institute - official website
Starting date: September 2001
Last updated: April 26, 2012
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