Risperdal Consta for Bipolar Disorder
Public ClinicalTrials.gov record NCT00177164. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Random Assignment,Parallel Group, Open Label Comparison of Clinical Outcomes and Resource Utilization Among Bipolar Disorder Patients Receiving Either Long Acting Injectable Risperidone Microspheres (Risperdal Consta® ) or Other Second Generation Oral Antipsychotic Agents: A 15 Month Study
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
We recruited 50 consenting adult subjects with DSM-IV TR diagnoses of bipolar disorder who were about to initiate or switch their current antipsychotic agent. Only 48 patients (23 in the risperidone LAI group and 25 in the oral AAP group) contributed data to the assessments. Patients were titrated and cross-tapered during a 3 month titration and stabilization phase. They were followed for an additional 12 months. Clinical outcomes such as study drop out, adverse events, worsening of symptoms, crisis interventions, need for additional medication, hospitalizations etc. were evaluated from months 3 to 15. The numbers of clinical events (pooled) will be used to evaluate if the long acting injectable form of risperidone has an advantage over the oral second generation antipsychotic agents in terms of treatment continuity and clinical stability.
Study identification
- NCT ID
- NCT00177164
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 50 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years to 70 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Oct 31, 2003
- Primary completion
- Feb 29, 2008
- Completion
- Nov 30, 2009
- Last update posted
- Apr 18, 2016
2003 – 2009
United States locations
- U.S. sites
- 4
- U.S. states
- 1
- U.S. cities
- 4
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Mayview State Hospital | Bridgeville | Pennsylvania | 15017-1599 | — |
| Dubois Regional Medical Center | DuBois | Pennsylvania | 15801 | — |
| Mon-Yough Community Services, Inc. | McKeesport | Pennsylvania | 15132 | — |
| Western Psychiatric Institute and Clinic | Pittsburgh | Pennsylvania | 15213-2593 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT00177164, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Apr 18, 2016 · Synced Sep 1, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT00177164 live on ClinicalTrials.gov.