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

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ClinicalTrials.gov Identifier: NCT00296686
Recruitment Status : Terminated (Study is no longer funded.)
First Posted : February 27, 2006
Last Update Posted : April 27, 2012
Sponsor:
Information provided by (Responsible Party):
New York State Psychiatric Institute

Study Description
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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
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Study Type : Interventional  (Clinical Trial)
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 : September 2001
Actual Primary Completion Date : August 2006
Actual Study Completion Date : August 2006

Resource links provided by the National Library of Medicine


Arms and Interventions
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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 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


Outcome Measures
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Primary Outcome Measures :
  1. Hamilton Depression Scale (HAM-D) [ Time Frame: up to 10 mos. ]

Secondary Outcome Measures :
  1. Beck Depression Inventory (BDI) [ Time Frame: up to 10 mos. ]
  2. Clinical Global Impression (CGI) [ Time Frame: up to 10 mos. ]
  3. Patient Global Impression (PGI) [ Time Frame: up to 10 mos. ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00296686


Locations
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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
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Principal Investigator: Jonathan W. Stewart, MD New York State Psychiatric Institute - Columbia University Department of Psychiatry
More Information
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Additional Information:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: New York State Psychiatric Institute
ClinicalTrials.gov Identifier: NCT00296686    
Other Study ID Numbers: #4213
First Posted: February 27, 2006    Key Record Dates
Last Update Posted: April 27, 2012
Last Verified: April 2012
Keywords provided by New York State Psychiatric Institute:
Major Depression
Refractory Depression
Tranylcypromine
Dextroamphetamine
Triiodothyronine
Additional relevant MeSH terms:
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Depression
Depressive Disorder
Depressive Disorder, Major
Depressive Disorder, Treatment-Resistant
Behavioral Symptoms
Mood Disorders
Mental Disorders
Tranylcypromine
Dextroamphetamine
Central Nervous System Stimulants
Physiological Effects of Drugs
Dopamine Uptake Inhibitors
 Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Dopamine Agents
Neurotransmitter Agents
Antidepressive Agents
Psychotropic Drugs
Monoamine Oxidase Inhibitors
Enzyme Inhibitors
Anti-Anxiety Agents
Tranquilizing Agents
Central Nervous System Depressants