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NCT00431184 · ClinicalTrials.gov registry record · Phase 2
Effects of Pentazocine Versus Lorazepam on Manic Symptoms
A Phase 2 study of Bipolar Disorder and Schizoaffective Disorder, sponsored by Mclean Hospital.
- Completed
- Registry status
- Phase 2
- Development phase
- 19
- Enrollment target
- 1
- Study location
NCT00431184: Completed Phase 2 study of Bipolar Disorder and Schizoaffective Disorder, sponsored by Mclean Hospital.
NCT00431184 is a Phase 2 study of Bipolar Disorder and Schizoaffective Disorder that has completed, run by Mclean Hospital. The registered enrollment target is 19 participants, below the 333-participant average among 162 other Bipolar Disorder trials with a reported enrollment target (94% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00431184, a Phase 2 study of Bipolar Disorder and Schizoaffective Disorder, has completed, sponsored by Mclean Hospital.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 19 participants
- Enrollment target
- 1
- Study location
Study Summary
Pilot data indicates that pentazocine decreases manic symptoms in hospitalized individuals. To follow up these initial findings, we plan to conduct a larger, more rigorous, double-blind study. We will examine whether pentazocine, an agent with kappa-opiate activity, decreases manic symptoms.
Primary Outcome
Assessment of current mania symptoms using Mania Acute Change Scale (MACS). All 20 questions on the scale have a 0 (absent)-4(most severe) range for describing mania symptoms. The mean MACS score totals were reported, with the total ranging from 0-80. A higher total score indicates a greater number of symptoms and higher symptom intensity, while a smaller score indicates a lesser number of symptoms and higher lower intensity. The change in MACS scores from baseline and those following treatment
Conditions Studied
Interventions
- DRUG Lorazepam
- DRUG Pentazocine
Study Locations (1)
Massachusetts
- McLean Hospital - Belmont
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 19 participants |
| Start Date | 2007-01 |
| Est. Completion | 2011-03 |
| Phase | Phase 2 |
What the finished NCT00431184 record still lists
NCT00431184 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 19 participants, a relatively small participant target, below the 333-participant average among 162 other Bipolar Disorder trials with a reported enrollment target (94% lower).
The record links to 5 conditions, with Bipolar Disorder appearing as the primary indexed condition, and to 2 interventions - of which Lorazepam is the first listed.
NCT00431184 reports a single indexed study location in Massachusetts.
Frequently Asked Questions
What is clinical trial NCT00431184 about?
NCT00431184 is a clinical study titled "Effects of Pentazocine Versus Lorazepam on Manic Symptoms". Pilot data indicates that pentazocine decreases manic symptoms in hospitalized individuals. To follow up these initial findings, we plan to conduct a larger, more rigorous, double-blind study. We will examine whether pentazocine, an agent with kappa-opiate activity, decreases manic symptoms.
What is the current status of trial NCT00431184?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 19 participants. The study started on 2007-01. Estimated completion is 2011-03.
What conditions does trial NCT00431184 study?
This clinical trial studies the following conditions: Bipolar Disorder, Schizoaffective Disorder, Mania, Manic Disorder, Manic State.
What interventions are being tested in trial NCT00431184?
The interventions under investigation include: Lorazepam (DRUG), Pentazocine (DRUG).
Who is sponsoring clinical trial NCT00431184?
This trial is sponsored by Mclean Hospital, which has 140 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00431184 being conducted?
This trial has 1 study location across Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Bipolar Disorder
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT00431184's enrollment target sits among peer trials
19 158th of 162 higher than 4 of 162 other Bipolar Disorder trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Bipolar Disorder 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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