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Tranylcypromine Treatment of Bipolar Depression

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified September 2011 by New York State Psychiatric Institute.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01430455
First Posted: September 8, 2011
Last Update Posted: October 24, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
New York State Psychiatric Institute
September 6, 2011
September 8, 2011
October 24, 2017
May 2011
May 2013   (Final data collection date for primary outcome measure)
Hamilton Rating Scale for Depression (HAMD) [ Time Frame: Weekly or bi-weekly for 16 week study duration ]
Same as current
Complete list of historical versions of study NCT01430455 on ClinicalTrials.gov Archive Site
  • Quick Inventory of Depressive Illness (QIDS) [ Time Frame: Weekly or bi-weekly for entire 16 week study duration ]
  • Symptom Check List - 90 items (SCL-90) [ Time Frame: Administered four times throughout 16 week study ]
  • Patient Global Impression Scale (PGI) [ Time Frame: Weekly or bi-weekly throughout the 16 week study ]
  • Modified Clinical Monitoring Form (M-CMF) [ Time Frame: Weekly or bi-weekly throughout the 16 week study ]
  • Social Adjustment Scale (SAS) [ Time Frame: Administered four times throughout the 16 week study ]
Same as current
Not Provided
Not Provided
 
Tranylcypromine Treatment of Bipolar Depression
Tranylcypromine Treatment of Bipolar Depression
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.
Not Provided
Interventional
Phase 4
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Bipolar Disorder I or II
Drug: Tranylcypromine
Tranylcypromine, between 10 mg/day and 120 mg/day throughout 16 week study
Other Name: Parnate®
Experimental: Tranylcypromine
Active, open-label tranylcypromine treatment
Intervention: Drug: Tranylcypromine
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Unknown status
50
Not Provided
May 2013   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years to 65 Years   (Adult)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01430455
6333
Yes
Not Provided
Not Provided
New York State Psychiatric Institute
New York State Psychiatric Institute
Not Provided
Not Provided
New York State Psychiatric Institute
September 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP