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Tranylcypromine Treatment of Bipolar Depression

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2011 by New York State Psychiatric Institute.
Recruitment status was  Recruiting
Sponsor:
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
  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:

  1. History of Bipolar I, II
  2. Currently depressed (major depressive episode or depression NOS)
  3. Physically healthy or physically stable (i.e.,No changes in medical interventions in past three months or likely for the next three months)
  4. On stable and effective mood stabilizer or hypomania deemed sufficiently mild to not require a mood stabilizer.
  5. Prior adequate trial on at least one antidepressant.
  6. Able to follow a tyramine-free diet
  7. Must speak English

Exclusion Criteria:

  1. Current psychosis
  2. past psychosis not occurring during an episode of mania or depression
  3. prior nonremission to tranylcypromine 60 mg/d (or greater)
  4. currently taking effective medication precluded while taking a MAOI (e.g., a psychostimulant or a serotonin re-uptake inhibitor)
  5. current (last six months) drug or alcohol abuse or dependence
  6. significant suicide risk
  7. significant cardiovascular risk
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Behavioral Symptoms
Mental Disorders
Mood Disorders
Tranylcypromine
Anti-Anxiety Agents
Antidepressive Agents
Central Nervous System Agents
Central Nervous System Depressants
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Monoamine Oxidase Inhibitors
Pharmacologic Actions
Physiological Effects of Drugs
Psychotropic Drugs
Therapeutic Uses
Tranquilizing Agents

ClinicalTrials.gov processed this record on November 23, 2014