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

This study has been terminated.
(Study is no longer funded.)
Sponsor:
Information provided by (Responsible Party):
New York State Psychiatric Institute
ClinicalTrials.gov Identifier:
NCT00296686
First received: February 23, 2006
Last updated: April 26, 2012
Last verified: April 2012
  Purpose

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


Condition Intervention Phase
Major Depression
Drug: Tranylcypromine
Drug: Dextroamphetamine
Drug: Triiodothyronine
Phase 4

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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.

Resource links provided by NLM:


Further study details as provided by New York State Psychiatric Institute:

Primary Outcome Measures:
  • Hamilton Depression Scale (HAM-D) [ Time Frame: up to 10 mos. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Beck Depression Inventory (BDI) [ Time Frame: up to 10 mos. ] [ Designated as safety issue: No ]
  • Clinical Global Impression (CGI) [ Time Frame: up to 10 mos. ] [ Designated as safety issue: No ]
  • Patient Global Impression (PGI) [ Time Frame: up to 10 mos. ] [ Designated as safety issue: No ]

Enrollment: 31
Study Start Date: September 2001
Study Completion Date: August 2006
Primary Completion Date: August 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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 Name: 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 Name: Cytomel

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

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00296686

Locations
United States, New York
Depression Evaluation Service - New York State Psychiatric Institute
New York, New York, United States, 10032
Sponsors and Collaborators
New York State Psychiatric Institute
Investigators
Principal Investigator: Jonathan W. Stewart, MD New York State Psychiatric Institute - Columbia University Department of Psychiatry
  More Information

Additional Information:
No publications provided by New York State Psychiatric Institute

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: New York State Psychiatric Institute
ClinicalTrials.gov Identifier: NCT00296686     History of Changes
Other Study ID Numbers: #4213
Study First Received: February 23, 2006
Last Updated: April 26, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by New York State Psychiatric Institute:
Major Depression
Refractory Depression
Tranylcypromine
Dextroamphetamine
Triiodothyronine

Additional relevant MeSH terms:
Depression
Depressive Disorder
Depressive Disorder, Major
Depressive Disorder, Treatment-Resistant
Behavioral Symptoms
Mood Disorders
Mental Disorders
Dextroamphetamine
Tranylcypromine
Central Nervous System Stimulants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Dopamine Uptake Inhibitors
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Uptake Inhibitors
Antidepressive Agents
Psychotropic Drugs
Monoamine Oxidase Inhibitors
Enzyme Inhibitors
Anti-Anxiety Agents
Tranquilizing Agents
Central Nervous System Depressants

ClinicalTrials.gov processed this record on September 22, 2014