Bipolar Disorder Clinical Trial
Official title:
Investigating Factors Affecting Clinical Trial Participation Rates in Patients With Bipolar Disorder
| NCT number | NCT05891639 |
| Other study ID # | 81011326 |
| Secondary ID | |
| Status | Not yet recruiting |
| Phase | |
| First received | |
| Last updated | |
| Start date | June 2024 |
| Est. completion date | June 2026 |
Participation in clinical trials usually favors a particular demographic group. But there is limited research available to explain what study attributes affect the completion of these specific demographic groups. This study will investigate the safety and efficacy of bipolar disorder treatments. The focus will be on tracking the rates of completion and withdrawal among these individuals. It will also try to analyze data from the perspective of different demographic groups to check for recurring trends which might yield insights for the sake of future bipolar disorder study.
| Status | Not yet recruiting |
| Enrollment | 500 |
| Est. completion date | June 2026 |
| Est. primary completion date | June 2025 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility | Inclusion Criteria: - Patient is at least 18 years of age - Diagnosis of bipolar disorder - Ability to understand a written informed consent document, and the willingness to sign it. Exclusion Criteria: - Women of childbearing potential without a negative pregnancy test; or women who are lactating. - Has a serious medical or psychiatric illness likely to interfere with participation in this clinical study. - Inability to perform regular electronic reporting |
| Country | Name | City | State |
|---|---|---|---|
| United States | Power Life Sciences | San Francisco | California |
| Lead Sponsor | Collaborator |
|---|---|
| Power Life Sciences Inc. |
United States,
Perugi G, Medda P, Toni C, Mariani MG, Socci C, Mauri M. The Role of Electroconvulsive Therapy (ECT) in Bipolar Disorder: Effectiveness in 522 Patients with Bipolar Depression, Mixed-state, Mania and Catatonic Features. Curr Neuropharmacol. 2017 Apr;15(3):359-371. doi: 10.2174/1570159X14666161017233642. — View Citation
Rakofsky JJ, Dunlop BW. Treating nonspecific anxiety and anxiety disorders in patients with bipolar disorder: a review. J Clin Psychiatry. 2011 Jan;72(1):81-90. doi: 10.4088/JCP.09r05815gre. Epub 2010 Nov 16. — View Citation
Yeom JW, Cho CH, Jeon S, Seo JY, Son S, Ahn YM, Kim SJ, Ha TH, Cha B, Moon E, Park DY, Baek JH, Kang HJ, An H, Lee HJ. Bipolar II disorder has the highest prevalence of seasonal affective disorder in early-onset mood disorders: Results from a prospective observational cohort study. Depress Anxiety. 2021 Jun;38(6):661-670. doi: 10.1002/da.23153. Epub 2021 Apr 5. — View Citation
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Rate of bipolar disorder patients who decide to enroll in a clinical research. | 3 months | ||
| Primary | Number of bipolar disorder study participants who remain in clinical research until completion. | 12 months |
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