Clinical trial NCT00296686: Sequential Tranylcypromine (TC), TC + Dextroamphetamine and TC + Triiodothyronine for Refractory Depression
Official title: A Pilot Study of Treatment for Refractory Depression With Sequential Trials of Tranylcypromine, Tranylcypromine Plus Dextroamphetamine, Tranylcypromine Plus Triiodothyronine.
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Major Depression
Keywords: Major Depression
Refractory Depression
Tranylcypromine
Dextroamphetamine
Triiodothyronine
Lead sponsor: New York State Psychiatric Institute
Sponsor class: OTHER
First posted: 2006-02-27
Enrollment: 31
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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 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 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

Primary outcomes:
measure: Hamilton Depression Scale (HAM-D)
timeFrame: up to 10 mos.
Secondary outcomes:
measure: Beck Depression Inventory (BDI)
timeFrame: up to 10 mos.
measure: Clinical Global Impression (CGI)
timeFrame: up to 10 mos.
measure: Patient Global Impression (PGI)
timeFrame: up to 10 mos.
Other outcomes:
Locations:
city: New York
country: United States
facility: Depression Evaluation Service - New York State Psychiatric Institute
state: New York
Study officials:
affiliation: New York State Psychiatric Institute - Columbia University Department of Psychiatry
name: Jonathan W. Stewart, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Stewart JW, Deliyannides DA, McGrath PJ. How treatable is refractory depression? J Affect Disord. 2014;167:148-52. doi: 10.1016/j.jad.2014.05.047. Epub 2014 Jun 4.