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NCT01131559 · ClinicalTrials.gov registry record · Phase 3
Adjunctive Lisdexamfetamine (LDX) in Bipolar Depression
A Phase 3 study, sponsored by Lindner Center of HOPE.
- Terminated
- Registry status
- Phase 3
- Development phase
- 50
- Enrollment target
NCT01131559: Clinical Trial Phase 3 study, sponsored by Lindner Center of HOPE.
NCT01131559 is a Phase 3 study that was terminated before completion, run by Lindner Center of HOPE. The registered enrollment target is 50 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (94% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01131559, a Phase 3 study, was terminated before completion, sponsored by Lindner Center of HOPE.
- TERMINATED
- Registry status
- Phase 3
- Development phase
- 50 participants
- Enrollment target
Study Summary
The specific aim of this study is to evaluate the efficacy and tolerability of lisdexamfetamine in the adjunctive treatment of bipolar disorder.
Primary Outcome
The primary efficacy variable is baseline-to-endpoint change in Montgomery-Asberg Depression Rating Scale (MADRS) score.
Interventions
- DRUG Placebo control
- DRUG Lisdexamfetamine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 50 participants |
| Start Date | 2010-01 |
| Est. Completion | 2014-02 |
| Phase | Phase 3 |
Why NCT01131559 stopped before completion
NCT01131559 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 50 participants, a relatively small participant target, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (94% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo control is the first listed.
NCT01131559 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01131559 about?
NCT01131559 is a clinical study titled "Adjunctive Lisdexamfetamine (LDX) in Bipolar Depression". The specific aim of this study is to evaluate the efficacy and tolerability of lisdexamfetamine in the adjunctive treatment of bipolar disorder.
What is the current status of trial NCT01131559?
This trial is currently terminated. It is a Phase 3 study. The enrollment target is 50 participants. The study started on 2010-01. Estimated completion is 2014-02.
What interventions are being tested in trial NCT01131559?
The interventions under investigation include: Placebo control (DRUG), Lisdexamfetamine (DRUG).
Who is sponsoring clinical trial NCT01131559?
This trial is sponsored by Lindner Center of HOPE, which has 23 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01131559's enrollment target sits among peer trials
50 1844th of 2000 higher than 141 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 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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