An In Depth Study Evaluating The Experiences of Patients In Schizophrenia Research

NCT ID: NCT05870722

Last Updated: 2023-05-23

Basic Information

• 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

Historically, research participation has been biased toward certain demographics. However, there is a shortage of studies that delve into the underlying factors that influence patient participation, both positively and negatively.

Several people will be invited to enroll in this study so that it may collect a variety of data about schizophrenia clinical trial experiences and identify barriers to participation as well as the causes of participants' failure or withdrawal.

The data collected from this study will be analyzed and used to improve the experiences of future schizophrenia patients who are recruited for medical trials.

Conditions

Schizophrenia

Study Design

• Observational Model Type: CASE_CROSSOVER
• Study Time Perspective: PROSPECTIVE

Eligibility Criteria

Inclusion Criteria

• Patient has self-identified as planning to enroll in a clinical trial
• Patient has been diagnosed with schizophrenia
• Patient is a minimum of 18 years or older

Exclusion Criteria

• Patient does not understand, sign, and return consent form
• Inability to perform regular electronic reporting
• Patient is pregnant

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Power Life Sciences Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Michael B Gill

Role: STUDY_DIRECTOR

Power Life Sciences Inc.

Central Contacts

Michael B Gill

Role: CONTACT

bask@withpower.com

4159004227

References

Barnett PG, Scott JY, Rosenheck RA; CSP 555 Study Group. How do clinical trial participants compare to other patients with schizophrenia? Schizophr Res. 2011 Aug;130(1-3):34-9. doi: 10.1016/j.schres.2011.03.033. Epub 2011 Apr 22.

Reference Type: BACKGROUND

PMID: 21514794 (View on PubMed)

Kishimoto T, Robenzadeh A, Leucht C, Leucht S, Watanabe K, Mimura M, Borenstein M, Kane JM, Correll CU. Long-acting injectable vs oral antipsychotics for relapse prevention in schizophrenia: a meta-analysis of randomized trials. Schizophr Bull. 2014 Jan;40(1):192-213. doi: 10.1093/schbul/sbs150. Epub 2012 Dec 17.

Reference Type: BACKGROUND

PMID: 23256986 (View on PubMed)

Maric NP, Jovicic MJ, Mihaljevic M, Miljevic C. Improving Current Treatments for Schizophrenia. Drug Dev Res. 2016 Nov;77(7):357-367. doi: 10.1002/ddr.21337. Epub 2016 Sep 16.

Reference Type: BACKGROUND

PMID: 27633376 (View on PubMed)

Provided Documents

Document Type: Informed Consent Form

View Document

Other Identifiers

84771018

Identifier Type: -

Identifier Source: org_study_id