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

Major Depression Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00296686
• Other study ID #: #4213
• Status: Terminated
• Phase: Phase 4
• First received: February 23, 2006
• Last updated: April 26, 2012
• Start date: September 2001
• Est. completion date: August 2006

Study information

• Verified date: April 2012
• Source: New York State Psychiatric Institute
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 31
• Est. completion date: August 2006
• Est. primary completion date: August 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Depressive Disorder, Major
• Depressive Disorder, Treatment-Resistant
• Major Depression

Intervention

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.
• 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.
• 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).

Locations

Country	Name	City	State
United States	Depression Evaluation Service - New York State Psychiatric Institute	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
New York State Psychiatric Institute

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hamilton Depression Scale (HAM-D)		up to 10 mos.	No
Secondary	Beck Depression Inventory (BDI)		up to 10 mos.	No
Secondary	Clinical Global Impression (CGI)		up to 10 mos.	No
Secondary	Patient Global Impression (PGI)		up to 10 mos.	No

External Links

•   Depression Evaluation Service - official website
•   New York State Psychiatric Institute - official website