| February 23, 2006 |
| January 14, 2008 |
| September 2001 |
| August 2006 (final data collection date for primary outcome measure) |
| Hamilton Depression Scale (HAM-D) [ Time Frame: up to 10 mos. ] [ Designated as safety issue: No ] |
| Hamilton Depression Scale (HAM-D) |
| Complete list of historical versions of study NCT00296686 on ClinicalTrials.gov Archive Site |
- 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 ]
|
- Beck Depression Inventory (BDI)
- Clinical Global Impression (CGI)
- Patient Global Impression (PGI)
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| |
| Tranylcypromine, Tranylcypromine Plus Dextroamphetamine and Tranylcypromine Plus Triiodothyronine as Treatment for Refractory Depression |
| A Pilot Study of Treatment for Refractory Depression With Sequential Trials of Tranylcypromine, Tranylcypromine Plus Dextroamphetamine, Tranylcypromine Plus Triiodothyronine. |
This pilot study will assess the efficacy of several sequential pharmacological treatments for patients with Refractory Depression. |
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. |
| Phase IV |
| Interventional |
| Treatment, Non-Randomized, Open Label, Uncontrolled, Crossover Assignment, Efficacy Study |
| Major Depression |
- Drug: Tranylcypromine
- Drug: Dextroamphetamine
- Drug: Triiodothyronine
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| |
| |
| |
| Terminated |
| 31 |
|
| August 2006 (final data collection date for primary outcome measure) |
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
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| Both |
| 18 Years to 65 Years |
| No |
| Contact information is only displayed when the study is recruiting subjects |
| United States |
| |
| NCT00296686 |
| Jonathan W. Stewart, M.D., New York State Psychiatric Institute |
| IRB4213, NCT00296686 |
| New York State Psychiatric Institute |
|
| Principal Investigator: |
Jonathan W. Stewart, MD |
New York State Psychiatric Institute - Columbia University Department of Psychiatry |
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| New York State Psychiatric Institute |
| January 2008 |
