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NCT00411463 · ClinicalTrials.gov registry record · Phase 2
Psychotherapy for Bipolar II Depression, Pilot Study, Phase II
A Phase 2 study of Bipolar II Disorder, sponsored by University of Pittsburgh.
- Completed
- Registry status
- Phase 2
- Development phase
- 25
- Enrollment target
- 1
- Study location
NCT00411463: Completed Phase 2 study of Bipolar II Disorder, sponsored by University of Pittsburgh.
NCT00411463 is a Phase 2 study of Bipolar II Disorder that has completed, run by University of Pittsburgh. The registered enrollment target is 25 participants, below the 81-participant average among 14 other Bipolar II Disorder trials with a reported enrollment target (69% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00411463, a Phase 2 study of Bipolar II Disorder, has completed, sponsored by University of Pittsburgh.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 25 participants
- Enrollment target
- 1
- Study location
Study Summary
Purpose of this study is to examine the effectiveness of an experimental psychotherapy (talk therapy) for the treatment of bipolar II depression. The name of this psychotherapy is Interpersonal and Social Rhythm Therapy for Bipolar II Depression (IPSRT-BPII). Subjects will be randomly assigned to receive either IPSRT-BPII or the medication Seroquel (quetiapine) to manage their symptoms of bipolar II depression. Subjects will receive the assigned therapy for up to 20 weeks.
Primary Outcome
Overall response rates (defined as greater than or equal to 50% reduction in depression scores without an increase in mania scores) were 29% (n=4) in the IPSRT group and 27% (n=3) in the quetiapine group. HRSD-25 scores are based on first 17 responses. Eight items are scored on a 5-pt scale, from 0 (not present) to 4 (severe.) Other nine items on the assessment are scored from 0-2. The higher the score on the HRSD-25, the worse the outcome is considered to be. A score of 0-7 is considered to be
Conditions Studied
Interventions
- BEHAVIORAL Interpersonal and Social Rhythm Therapy (IPSRT-BPII)
- DRUG Seroquel
Study Locations (1)
Pennsylvania
- University of Pittsburgh /University of Pittsburgh Medical Center (UPMC) - Pittsburgh
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 25 participants |
| Start Date | 2006-12 |
| Est. Completion | 2010-09 |
| Phase | Phase 2 |
What the finished NCT00411463 record still lists
NCT00411463 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 25 participants, a relatively small participant target, below the 81-participant average among 14 other Bipolar II Disorder trials with a reported enrollment target (69% lower).
The record links to 1 condition, with Bipolar II Disorder appearing as the primary indexed condition, and to 2 interventions - of which Interpersonal and Social Rhythm Therapy (IPSRT-BPII) is the first listed.
NCT00411463 reports a single indexed study location in Pennsylvania.
Frequently Asked Questions
What is clinical trial NCT00411463 about?
NCT00411463 is a clinical study titled "Psychotherapy for Bipolar II Depression, Pilot Study, Phase II". Purpose of this study is to examine the effectiveness of an experimental psychotherapy (talk therapy) for the treatment of bipolar II depression. The name of this psychotherapy is Interpersonal and Social Rhythm Therapy for Bipolar II Depression (IPSRT-BPII). Subjects will be randomly assigned to re...
What is the current status of trial NCT00411463?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 25 participants. The study started on 2006-12. Estimated completion is 2010-09.
What conditions does trial NCT00411463 study?
This clinical trial studies the following conditions: Bipolar II Disorder.
What interventions are being tested in trial NCT00411463?
The interventions under investigation include: Interpersonal and Social Rhythm Therapy (IPSRT-BPII) (BEHAVIORAL), Seroquel (DRUG).
Who is sponsoring clinical trial NCT00411463?
This trial is sponsored by University of Pittsburgh, which has 1,238 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00411463 being conducted?
This trial has 1 study location across Pennsylvania. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Bipolar II 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 NCT00411463's enrollment target sits among peer trials
25 11th of 14 higher than 4 of 14 other Bipolar II Disorder trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Bipolar II 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.
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