Tranylcypromine, Tranylcypromine Plus Dextroamphetamine and Tranylcypromine Plus Triiodothyronine as Treatment for Refractory Depression - Full Text View

Sponsored by:	New York State Psychiatric Institute
Information provided by:	New York State Psychiatric Institute
ClinicalTrials.gov Identifier:	NCT00296686

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 IV

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Crossover Assignment, Efficacy Study
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:

MedlinePlus related topics: Depression

Drug Information available for: Dextroamphetamine sulfate Dextroamphetamine Liothyronine sodium Tranylcypromine sulfate Tranylcypromine Triiodothyronine

U.S. FDA Resources

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
Primary Completion Date:	August 2006 (Final data collection date for primary outcome measure)

Intervention Details:

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.

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.

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).

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

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:

Depression Evaluation Service - official website This link exits the ClinicalTrials.gov site

New York State Psychiatric Institute - official website This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	New York State Psychiatric Institute ( Jonathan W. Stewart, M.D. )
Study ID Numbers:	IRB4213, NCT00296686
Study First Received:	February 23, 2006
Last Updated:	January 14, 2008
ClinicalTrials.gov Identifier:	NCT00296686 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by New York State Psychiatric Institute:

Major Depression
Refractory Depression
Tranylcypromine
Dextroamphetamine
Triiodothyronine

Study placed in the following topic categories:

Dopamine Uptake Inhibitors
Neurotransmitter Agents
Tranquilizing Agents
Depression
Psychotropic Drugs
Central Nervous System Depressants
Central Nervous System Stimulants
Depressive Disorder, Major
Depressive Disorder

Tranylcypromine
Behavioral Symptoms
Dopamine
Mental Disorders
Dextroamphetamine
Mood Disorders
Anti-Anxiety Agents
Dopamine Agents
Antidepressive Agents

Additional relevant MeSH terms:

Dopamine Uptake Inhibitors
Neurotransmitter Agents
Neurotransmitter Uptake Inhibitors
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Psychotropic Drugs
Depressive Disorder, Major
Tranylcypromine
Mental Disorders
Therapeutic Uses
Monoamine Oxidase Inhibitors
Antidepressive Agents
Depression

Tranquilizing Agents
Central Nervous System Depressants
Central Nervous System Stimulants
Enzyme Inhibitors
Depressive Disorder
Pharmacologic Actions
Behavioral Symptoms
Dextroamphetamine
Mood Disorders
Dopamine Agents
Anti-Anxiety Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on July 02, 2009