Back to resultsSequential Tranylcypromine (TC), TC + Dextroamphetamine and TC + Triiodothyronine for Refractory Depression
Primary Purpose
Major Depression
Status
Terminated
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Tranylcypromine
Dextroamphetamine
Triiodothyronine
Sponsored by
About this trial
This is an interventional treatment trial for Major Depression focused on measuring Major Depression, Refractory Depression, Tranylcypromine, Dextroamphetamine, Triiodothyronine
Eligibility 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
Sites / Locations
- Depression Evaluation Service - New York State Psychiatric Institute
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
tranylcypromine
Arm Description
sequential tranylcypromine (TC) followed by TC + dextroamphetamine followed by TC + T3
Outcomes
Primary Outcome Measures
Hamilton Depression Scale (HAM-D)
Secondary Outcome Measures
Beck Depression Inventory (BDI)
Clinical Global Impression (CGI)
Patient Global Impression (PGI)
Full Information
NCT ID
NCT00296686
First Posted
February 23, 2006
Last Updated
April 26, 2012
Sponsor
New York State Psychiatric Institute
1. Study Identification
Unique Protocol Identification Number
NCT00296686
Brief Title
Sequential Tranylcypromine (TC), TC + Dextroamphetamine and TC + Triiodothyronine for Refractory Depression
Official Title
A Pilot Study of Treatment for Refractory Depression With Sequential Trials of Tranylcypromine, Tranylcypromine Plus Dextroamphetamine, Tranylcypromine Plus Triiodothyronine.
Study Type
Interventional
2. Study Status
Record Verification Date
April 2012
Overall Recruitment Status
Terminated
Why Stopped
Study is no longer funded.
Study Start Date
September 2001 (undefined)
Primary Completion Date
August 2006 (Actual)
Study Completion Date
August 2006 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
New York State Psychiatric Institute
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
This pilot study will assess the efficacy of several sequential pharmacological treatments for patients with Refractory Depression.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Major Depression
Keywords
Major Depression, Refractory Depression, Tranylcypromine, Dextroamphetamine, Triiodothyronine
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
31 (Actual)
8. Arms, Groups, and Interventions
Arm Title
tranylcypromine
Arm Type
Experimental
Arm Description
sequential tranylcypromine (TC) followed by TC + dextroamphetamine followed by TC + T3
Intervention Type
Drug
Intervention Name(s)
Tranylcypromine
Other Intervention Name(s)
Parnate
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Dextroamphetamine
Other Intervention Name(s)
Dexedrine
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Triiodothyronine
Other Intervention Name(s)
Cytomel
Intervention Description
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).
Primary Outcome Measure Information:
Title
Hamilton Depression Scale (HAM-D)
Time Frame
up to 10 mos.
Secondary Outcome Measure Information:
Title
Beck Depression Inventory (BDI)
Time Frame
up to 10 mos.
Title
Clinical Global Impression (CGI)
Time Frame
up to 10 mos.
Title
Patient Global Impression (PGI)
Time Frame
up to 10 mos.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jonathan W. Stewart, MD
Organizational Affiliation
New York State Psychiatric Institute - Columbia University Department of Psychiatry
Official's Role
Principal Investigator
Facility Information:
Facility Name
Depression Evaluation Service - New York State Psychiatric Institute
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
24972362
Citation
Stewart JW, Deliyannides DA, McGrath PJ. How treatable is refractory depression? J Affect Disord. 2014;167:148-52. doi: 10.1016/j.jad.2014.05.047. Epub 2014 Jun 4.
Results Reference
derived
Links:
URL
http://www.depression-nyc.org
Description
Depression Evaluation Service - official website
URL
http://www.nyspi.org
Description
New York State Psychiatric Institute - official website
Learn more about this trial
Sequential Tranylcypromine (TC), TC + Dextroamphetamine and TC + Triiodothyronine for Refractory Depression
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