A Close Examination of Patient Experiences in Bipolar Disorder Clinical Trials

NCT05891639 | Not Yet Recruiting

• 1 other identifier: 81011326
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 1

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.

Conditions

Bipolar Disorder

Keywords

Bipolar Disorder

Outcome Measures

Primary Outcomes (2)

• Rate of bipolar disorder patients who decide to enroll in a clinical research.

  3 months

• Number of bipolar disorder study participants who remain in clinical research until completion.

  12 months

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Power Life Sciences Inc.: lead

Study Sites (1)

Power Life Sciences

San Francisco, California, 94107, United States

Location

Related Publications (3)

• 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.

  PMID: 28503107 BACKGROUND

• 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.

  PMID: 33818866 BACKGROUND

• 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.

  PMID: 21208580 BACKGROUND

MeSH Terms

Conditions

Bipolar Disorder

Condition Hierarchy (Ancestors)

Bipolar and Related Disorders; Mood Disorders; Mental Disorders

Study Officials

• Michael B Gill

  Power Life Sciences Inc.

  STUDY DIRECTOR

Central Study Contacts

Michael B Gill

CONTACT

415-900-4227; bask@withpower.com

Study Design

• Study Type: observational
• Observational Model: CASE CROSSOVER
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 26, 2023
• First Posted: June 7, 2023
• Study Start: June 1, 2024
• Primary Completion: June 1, 2025
• Study Completion: June 1, 2026
• Last Updated: June 7, 2023

Record last verified: 2023-05

Locations

US (1)