Clinical trial NCT05891639: 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
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Bipolar Disorder
Keywords: Bipolar Disorder
Lead sponsor: Power Life Sciences Inc.
Sponsor class: INDUSTRY
First posted: 2023-06-07
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CROSSOVER
Time perspective: PROSPECTIVE
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.

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.


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

Primary outcomes:
measure: Rate of bipolar disorder patients who decide to enroll in a clinical research.
timeFrame: 3 months
measure: Number of bipolar disorder study participants who remain in clinical research until completion.
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: Power Life Sciences
state: California
Study officials:
affiliation: Power Life Sciences Inc.
name: Michael B Gill
role: STUDY_DIRECTOR
References:
citation: 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.
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.
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.