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NCT01411085 · ClinicalTrials.gov registry record · Phase 2
Risperidone and Desipramine in Alcohol Use and Schizophrenia
A Phase 2 study, sponsored by Dartmouth-Hitchcock Medical Center.
- Completed
- Registry status
- Phase 2
- Development phase
- 12
- Enrollment target
NCT01411085: Completed Phase 2 study, sponsored by Dartmouth-Hitchcock Medical Center.
NCT01411085 is a Phase 2 study that has completed, run by Dartmouth-Hitchcock Medical Center. The registered enrollment target is 12 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (91% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01411085, a Phase 2 study, has completed, sponsored by Dartmouth-Hitchcock Medical Center.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 12 participants
- Enrollment target
Study Summary
Note: In June 2013, the study design was changed from a randomized controlled study of risperidone + despiramine vs. risperidone vs. placebo to an open label pre-post study of risperidone (or risperidone-like drug) + desipramine. The aims of the study were revised to read: 1. To determine whether participants treated with risperidone in combination with desiprmaine have less alcohol use (fewer drinking days; fewer heavy drinking days) during the final 8 weeks on these medications as compared to pre-baseline. The primary hypothesis is that compared to pre-baseline, participants will demonstrate fewer days of drinking (per week), as well as fewer days of heavy drinking (per week) in the final eight weeks they are taking risperidone and desipramine, as recorded on the Timeline Follow-Back assessment 2. To explore changes in symptoms (of schizophrenia and of depression) in the final eight weeks of treatment with risperidone + desipramine compared to the period before baseline 3. To assess the side effect burden associated with the combination of these two medications in participants. The original aims of the study were: The purpose of this study is to determine whether participants who are treated with risperidone in combination with desipramine have less alcohol use (fewer drinking days; fewer heavy drinking days) than do participants who are treated with RISP with placebo. The primary hypothesis is that compared to treatment with risperidone, participants randomized to a combination of risperidone plus desipramine will have fewer days of drinking, as well as fewer days of heavy drinking. The study will also compare the effects of risperidone as compared to risperidone plus desipramine on participants' symptoms and side effects.
Primary Outcome
Alcohol/other substance use (including tobacco) will be assessed primarily by weekly self-report using the Timeline Followback (TLFB) method enhanced by procedures to strengthen the reliability and validity of this measure. It involves asking participants to retrospectively estimate their alcohol and other substance use.
Interventions
- DRUG Risperidone + Desipramine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 12 participants |
| Start Date | 2011-12 |
| Est. Completion | 2014-09 |
| Phase | Phase 2 |
What the finished NCT01411085 record still lists
NCT01411085 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 12 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (91% lower).
The record links to 0 conditions, and to 1 intervention - of which Risperidone + Desipramine is the first listed.
NCT01411085 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01411085 about?
NCT01411085 is a clinical study titled "Risperidone and Desipramine in Alcohol Use and Schizophrenia". Note: In June 2013, the study design was changed from a randomized controlled study of risperidone + despiramine vs. risperidone vs. placebo to an open label pre-post study of risperidone (or risperidone-like drug) + desipramine. The aims of the study were revised to read: 1. To determine whether p...
What is the current status of trial NCT01411085?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 12 participants. The study started on 2011-12. Estimated completion is 2014-09.
What interventions are being tested in trial NCT01411085?
The interventions under investigation include: Risperidone + Desipramine (DRUG).
Who is sponsoring clinical trial NCT01411085?
This trial is sponsored by Dartmouth-Hitchcock Medical Center, which has 427 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01411085's enrollment target sits among peer trials
12 1948th of 2000 higher than 34 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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