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NCT01784666 · ClinicalTrials.gov registry record · Phase 2
Adjunctive Isradipine for the Treatment of Bipolar Depression
A Phase 2 study, sponsored by Massachusetts General Hospital.
- Terminated
- Registry status
- Phase 2
- Development phase
- 2
- Enrollment target
NCT01784666: Clinical Trial Phase 2 study, sponsored by Massachusetts General Hospital.
NCT01784666 is a Phase 2 study that was terminated before completion, run by Massachusetts General Hospital. The registered enrollment target is 2 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (98% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01784666, a Phase 2 study, was terminated before completion, sponsored by Massachusetts General Hospital.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 2 participants
- Enrollment target
Study Summary
This study investigates the medication isradipine, which is currently approved by the FDA to treat high blood pressure, in the treatment of depression in bipolar disorder. Isradipine or placebo (contains no active medication) will be used as an "add-on" to lithium, valproate, and/or atypical antipsychotics for individuals currently experiencing a major depressive episode. Our hypothesis is that isradipine will be superior to placebo in improving depressive symptoms.
Primary Outcome
Change in Montgomery-Asberg Depression Rating Scale (MADRS) in isradipine-treated epochs versus placebo-treated epochs. These scores represent total scores, and on the MADRS total scores range from 0-60. A higher score indicates increased depression severity.
Interventions
- DRUG Placebo
- DRUG Isradipine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 2 participants |
| Start Date | 2013-02 |
| Est. Completion | 2014-04 |
| Phase | Phase 2 |
Why NCT01784666 stopped before completion
NCT01784666 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 2 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (98% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT01784666 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01784666 about?
NCT01784666 is a clinical study titled "Adjunctive Isradipine for the Treatment of Bipolar Depression". This study investigates the medication isradipine, which is currently approved by the FDA to treat high blood pressure, in the treatment of depression in bipolar disorder. Isradipine or placebo (contains no active medication) will be used as an "add-on" to lithium, valproate, and/or atypical antipsy...
What is the current status of trial NCT01784666?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 2 participants. The study started on 2013-02. Estimated completion is 2014-04.
What interventions are being tested in trial NCT01784666?
The interventions under investigation include: Placebo (DRUG), Isradipine (DRUG).
Who is sponsoring clinical trial NCT01784666?
This trial is sponsored by Massachusetts General Hospital, which has 2,032 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01784666's enrollment target sits among peer trials
2 2001st of 2000 the lowest of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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