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Tranylcypromine Treatment of Bipolar Depression

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ClinicalTrials.gov Identifier: NCT01430455
Recruitment Status : Completed
First Posted : September 8, 2011
Results First Posted : March 15, 2018
Last Update Posted : March 15, 2018
Sponsor:
Information provided by (Responsible Party):
New York State Psychiatric Institute

September 6, 2011
September 8, 2011
September 25, 2017
March 15, 2018
March 15, 2018
November 2011
February 2014   (Final data collection date for primary outcome measure)
29 Item Hamilton Rating Scale for Depression (HamD29) [ Time Frame: Hamilton 29 score at baseline (start date of medication) and week 16 ]
29 Item Hamilton Rating Scale for Depression (HamD29) is the 29 item version of the most common depression rating scale. The scores represented here are the average scores at baseline and after 16 weeks of open label treatment. The scale is rated from 0-89 with higher scores representing a more depressed state.
Hamilton Rating Scale for Depression (HAMD) [ Time Frame: Weekly or bi-weekly for 16 week study duration ]
Complete list of historical versions of study NCT01430455 on ClinicalTrials.gov Archive Site
Not Provided
  • 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 ]
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
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.
 
Completed
7
50
September 2014
February 2014   (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 Monoamine Oxidase Inhibitor (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, Older 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
February 2018

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