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NCT01430455 · ClinicalTrials.gov registry record · Phase 4
Tranylcypromine Treatment of Bipolar Depression
A Phase 4 study, sponsored by New York State Psychiatric Institute.
- Completed
- Registry status
- Phase 4
- Development phase
- 7
- Enrollment target
NCT01430455: Completed Phase 4 study, sponsored by New York State Psychiatric Institute.
NCT01430455 is a Phase 4 study that has completed, run by New York State Psychiatric Institute. The registered enrollment target is 7 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (99% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01430455, a Phase 4 study, has completed, sponsored by New York State Psychiatric Institute.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 7 participants
- Enrollment target
Study Summary
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.
Primary Outcome
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.
Interventions
- DRUG Tranylcypromine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 7 participants |
| Start Date | 2011-11 |
| Est. Completion | 2014-09 |
| Phase | Phase 4 |
What the finished NCT01430455 record still lists
NCT01430455 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 7 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (99% lower).
The record links to 0 conditions, and to 1 intervention - of which Tranylcypromine is the first listed.
NCT01430455 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01430455 about?
NCT01430455 is a clinical study titled "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 ind...
What is the current status of trial NCT01430455?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 7 participants. The study started on 2011-11. Estimated completion is 2014-09.
What interventions are being tested in trial NCT01430455?
The interventions under investigation include: Tranylcypromine (DRUG).
Who is sponsoring clinical trial NCT01430455?
This trial is sponsored by New York State Psychiatric Institute, which has 364 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01430455's enrollment target sits among peer trials
7 1981st of 2000 higher than 18 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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