A Close Examination of Patient Experiences in Bipolar Disorder Clinical Trials

NCT ID: NCT05891639

Last Updated: 2023-06-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Total Enrollment

500 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-06-30

Study Completion Date

2026-06-30

Brief Summary

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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

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Conditions

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Bipolar Disorder

Study Design

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Observational Model Type

CASE_CROSSOVER

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Power Life Sciences Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Michael B Gill

Role: STUDY_DIRECTOR

Power Life Sciences Inc.

Locations

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Power Life Sciences

San Francisco, California, United States

Site Status

Countries

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United States

Central Contacts

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Michael B Gill

Role: CONTACT

415-900-4227

Facility Contacts

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Michael B Gill

Role: primary

References

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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.

Reference Type BACKGROUND
PMID: 28503107 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 33818866 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 21208580 (View on PubMed)

Provided Documents

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Document Type: Informed Consent Form

View Document

Other Identifiers

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81011326

Identifier Type: -

Identifier Source: org_study_id

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