Sequential Tranylcypromine (TC), TC + Dextroamphetamine and TC + Triiodothyronine for Refractory Depression
This study has been terminated.
(Study is no longer funded.)
Sponsor:
New York State Psychiatric Institute
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
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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:
MedlinePlus related topics:
Depression
Drug Information available for:
Dextroamphetamine sulfate
Dextroamphetamine
Liothyronine sodium
Liothyronine
Tranylcypromine sulfate
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 |
| 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
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
| 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 Behavioral Symptoms Mood Disorders Mental Disorders Dextroamphetamine Tranylcypromine Dopamine Uptake Inhibitors Dopamine Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Pharmacologic Actions |
Neurotransmitter Uptake Inhibitors Physiological Effects of Drugs Central Nervous System Stimulants Central Nervous System Agents Therapeutic Uses Monoamine Oxidase Inhibitors Enzyme Inhibitors Antidepressive Agents Psychotropic Drugs Anti-Anxiety Agents Tranquilizing Agents Central Nervous System Depressants |
ClinicalTrials.gov processed this record on May 19, 2013