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A Close Examination of Patient Experiences in Bipolar Disorder Clinical Trials

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05891639
Recruitment Status : Not yet recruiting
First Posted : June 7, 2023
Last Update Posted : June 7, 2023
Sponsor:
Information provided by (Responsible Party):
Power Life Sciences Inc.

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.


Condition or disease
Bipolar Disorder

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Study Type : Observational
Estimated Enrollment : 500 participants
Observational Model: Case-Crossover
Time Perspective: Prospective
Official Title: Investigating Factors Affecting Clinical Trial Participation Rates in Patients With Bipolar Disorder
Estimated Study Start Date : June 2024
Estimated Primary Completion Date : June 2025
Estimated Study Completion Date : June 2026

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bipolar Disorder




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


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05891639


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

Locations
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United States, California
Power Life Sciences
San Francisco, California, United States, 94107
Contact: Michael B Gill    415-900-4227    https://www.withpower.com/contact-us@withpower.com   
Sponsors and Collaborators
Power Life Sciences Inc.
Investigators
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Study Director: Michael B Gill Power Life Sciences Inc.
  Study Documents (Full-Text)

Documents provided by Power Life Sciences Inc.:
Informed Consent Form  [PDF] May 26, 2023

Publications:
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Responsible Party: Power Life Sciences Inc.
ClinicalTrials.gov Identifier: NCT05891639    
Other Study ID Numbers: 81011326
First Posted: June 7, 2023    Key Record Dates
Last Update Posted: June 7, 2023
Last Verified: May 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Power Life Sciences Inc.:
Bipolar Disorder
Additional relevant MeSH terms:
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Bipolar Disorder
Bipolar and Related Disorders
Mood Disorders
Mental Disorders