Tranylcypromine Treatment of Bipolar Depression
This study is currently recruiting participants.
Verified September 2011 by New York State Psychiatric Institute
Sponsor:
New York State Psychiatric Institute
Information provided by (Responsible Party):
New York State Psychiatric Institute
ClinicalTrials.gov Identifier:
NCT01430455
First received: September 6, 2011
Last updated: December 14, 2011
Last verified: September 2011
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Purpose
This study seeks to investigate whether tranylcypromine (Parnate®) might be an effective treatment of bipolar depression. New treatments are needed, as there is little evidence that standard antidepressants are effective in treating this condition, and the two antipsychotic medications that have indications for bipolar depression can cause substantial side effects. This study will focus specifically on currently depressed outpatients having a bipolar history for whom at least one standard antidepressant medication was ineffective. Patients will be treated openly with tranylcypromine for 8-10 months, depending on treatment response.
| Condition | Intervention | Phase |
|---|---|---|
|
Bipolar Disorder I or II |
Drug: Tranylcypromine |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Tranylcypromine Treatment of Bipolar Depression |
Resource links provided by NLM:
Further study details as provided by New York State Psychiatric Institute:
Primary Outcome Measures:
- Hamilton Rating Scale for Depression (HAMD) [ Time Frame: Weekly or bi-weekly for 16 week study duration ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Quick Inventory of Depressive Illness (QIDS) [ Time Frame: Weekly or bi-weekly for entire 16 week study duration ] [ Designated as safety issue: No ]
- Symptom Check List - 90 items (SCL-90) [ Time Frame: Administered four times throughout 16 week study ] [ Designated as safety issue: No ]
- Patient Global Impression Scale (PGI) [ Time Frame: Weekly or bi-weekly throughout the 16 week study ] [ Designated as safety issue: No ]
- Modified Clinical Monitoring Form (M-CMF) [ Time Frame: Weekly or bi-weekly throughout the 16 week study ] [ Designated as safety issue: No ]
- Social Adjustment Scale (SAS) [ Time Frame: Administered four times throughout the 16 week study ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 50 |
| Study Start Date: | May 2011 |
| Estimated Primary Completion Date: | May 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Tranylcypromine
Active, open-label tranylcypromine treatment
|
Drug: Tranylcypromine
Tranylcypromine, between 10 mg/day and 120 mg/day throughout 16 week study
Other Name: Parnate®
|
Eligibility| Ages Eligible for Study: | 18 Years to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- History of Bipolar I, II
- Currently depressed (major depressive episode or depression NOS)
- Physically healthy or physically stable (i.e.,No changes in medical interventions in past three months or likely for the next three months)
- On stable and effective mood stabilizer or hypomania deemed sufficiently mild to not require a mood stabilizer.
- Prior adequate trial on at least one antidepressant.
- Able to follow a tyramine-free diet
- Must speak English
Exclusion Criteria:
- Current psychosis
- past psychosis not occurring during an episode of mania or depression
- prior nonremission to tranylcypromine 60 mg/d (or greater)
- currently taking effective medication precluded while taking a MAOI (e.g., a psychostimulant or a serotonin re-uptake inhibitor)
- current (last six months) drug or alcohol abuse or dependence
- significant suicide risk
- significant cardiovascular risk
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01430455
Contacts
| Contact: Vito Agosti, M.S.W. | 212-543-5605 | agostiv@nyspi.columbia.edu |
| Contact: Jonathan W Stewart, M.D. | 212-543-5745 | jws6@columbia.edu |
Locations
| United States, New York | |
| New York State Psychiatric Institute | Recruiting |
| New York, New York, United States, 10032 | |
| Contact: Vito Agosti, M.S.W. 212-543-5605 agostiv@nyspi.columbia.edu | |
| Principal Investigator: Jonathan W Stewart, M.D. | |
| Sub-Investigator: David J Hellerstein, M.D. | |
| Sub-Investigator: Deborah A Deliyannides, M.D. | |
| Sub-Investigator: Patrick J McGrath, M.D. | |
| Sub-Investigator: Robin Bell, M.D. | |
Sponsors and Collaborators
New York State Psychiatric Institute
More Information
Additional Information:
No publications provided
| Responsible Party: | New York State Psychiatric Institute |
| ClinicalTrials.gov Identifier: | NCT01430455 History of Changes |
| Other Study ID Numbers: | 6333 |
| Study First Received: | September 6, 2011 |
| Last Updated: | December 14, 2011 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by New York State Psychiatric Institute:
|
Major Depressive Episode Depression NOS Bipolar Disorder Bipolar Disorder I |
Bipolar Disorder II Bipolar Depression Major Depression |
Additional relevant MeSH terms:
|
Bipolar Disorder Depression Depressive Disorder Affective Disorders, Psychotic Mood Disorders Mental Disorders Behavioral Symptoms Tranylcypromine Monoamine Oxidase Inhibitors Enzyme Inhibitors |
Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Antidepressive Agents Psychotropic Drugs Central Nervous System Agents Therapeutic Uses Anti-Anxiety Agents Tranquilizing Agents Central Nervous System Depressants Physiological Effects of Drugs |
ClinicalTrials.gov processed this record on May 19, 2013