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

Sponsor

New York State Psychiatric Institute (Other)

Overall Status

Terminated

CT.gov ID

NCT00296686

Collaborator

(none)

Enrollment

Location

Arm

Duration (Months)

0.5

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Major Depression	Drug: Tranylcypromine Drug: Dextroamphetamine Drug: Triiodothyronine	Phase 4

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

31 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

A Pilot Study of Treatment for Refractory Depression With Sequential Trials of Tranylcypromine, Tranylcypromine Plus Dextroamphetamine, Tranylcypromine Plus Triiodothyronine.

Study Start Date :

Sep 1, 2001

Actual Primary Completion Date :

Aug 1, 2006

Actual Study Completion Date :

Aug 1, 2006

Arms and Interventions

Arm	Intervention/Treatment
Experimental: tranylcypromine sequential tranylcypromine (TC) followed by TC + dextroamphetamine followed by TC + T3	Drug: Tranylcypromine standard dose:60 mg/d for a minimum of 8 weeks, a maximum of 17 weeks; high dose for non-remitters: up to 120 mg/day for a maximum of 9 weeks. Other Names: Parnate Drug: Dextroamphetamine up to 40 mg/day for 9 weeks, in combination with high dose of tranylcypromine for patients not remitting on the standard or high doses of tranylcypromine alone. Other Names: Dexedrine Drug: Triiodothyronine For patients not remitting on higher dose of tranylcypromine plus dextroamphetamine: Up to 75 mg/day for 8 weeks(+/- dextroamphetamine) (max 8 weeks) in combination with highest does of tranylcypromine (up to 120mg/day). Other Names: Cytomel

Arm

Intervention/Treatment

Experimental: tranylcypromine

sequential tranylcypromine (TC) followed by TC + dextroamphetamine followed by TC + T3

Drug: Tranylcypromine

standard dose:60 mg/d for a minimum of 8 weeks, a maximum of 17 weeks; high dose for non-remitters: up to 120 mg/day for a maximum of 9 weeks.

Other Names:

Parnate

Drug: Dextroamphetamine

up to 40 mg/day for 9 weeks, in combination with high dose of tranylcypromine for patients not remitting on the standard or high doses of tranylcypromine alone.

Other Names:

Dexedrine

Drug: Triiodothyronine

For patients not remitting on higher dose of tranylcypromine plus dextroamphetamine: Up to 75 mg/day for 8 weeks(+/- dextroamphetamine) (max 8 weeks) in combination with highest does of tranylcypromine (up to 120mg/day).

Other Names:

Cytomel

Outcome Measures

Primary Outcome Measures

Hamilton Depression Scale (HAM-D) [up to 10 mos.]

Secondary Outcome Measures

Beck Depression Inventory (BDI) [up to 10 mos.]
Clinical Global Impression (CGI) [up to 10 mos.]
Patient Global Impression (PGI) [up to 10 mos.]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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