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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

Page last updated: August 23, 2015

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