A Close Examination of Patient Experiences in Bipolar Disorder Clinical Trials

• ClinicalTrials.gov Identifier: NCT05891639
• Recruitment Status: Not yet recruiting
• First Posted: June 7, 2023
• Last Update Posted: June 7, 2023
• Sponsor: Power Life Sciences Inc.
• Information provided by (Responsible Party): Power Life Sciences Inc.

Tracking Information

• First Submitted Date: May 26, 2023
• First Posted Date: June 7, 2023
• Last Update Posted Date: June 7, 2023
• Estimated Study Start Date: June 2024
• Estimated Primary Completion Date: June 2025 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: May 26, 2023)

• Rate of bipolar disorder patients who decide to enroll in a clinical research. [ Time Frame: 3 months ]
• Number of bipolar disorder study participants who remain in clinical research until completion. [ Time Frame: 12 months ]

• Original Primary Outcome Measures: Same as current
• Change History: No Changes Posted
• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: A Close Examination of Patient Experiences in Bipolar Disorder Clinical Trials
• Official Title: Investigating Factors Affecting Clinical Trial Participation Rates in Patients With Bipolar Disorder

Brief Summary

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.

• Detailed Description: Not Provided
• Study Type: Observational
• Study Design: Observational Model: Case-Crossover; Time Perspective: Prospective
• Target Follow-Up Duration: Not Provided
• Biospecimen: Not Provided
• Sampling Method: Probability Sample
• Study Population: Patients who are actively considering involvement in an observational bipolar disorder clinical trial, but have not yet completed enrollment and registration.
• Condition: Bipolar Disorder
• Intervention: Not Provided
• Study Groups/Cohorts: Not Provided

Publications *

• 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.
• 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.
• 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.

Recruitment Information

• Recruitment Status: Not yet recruiting
• Estimated Enrollment (submitted: May 26, 2023): 500
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: June 2026
• Estimated Primary Completion Date: June 2025 (Final data collection date for primary outcome measure)

Eligibility Criteria

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Contacts

Contact: Michael B Gill; 415-900-4227; bask@withpower.com

• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT05891639
• Other Study ID Numbers: 81011326
• Has Data Monitoring Committee: Not Provided

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: Undecided

• Current Responsible Party: Power Life Sciences Inc.
• Original Responsible Party: Same as current
• Current Study Sponsor: Power Life Sciences Inc.
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Study Director: Michael B Gill; Power Life Sciences Inc.

• PRS Account: Power Life Sciences Inc.
• Verification Date: May 2023