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

NCT05870722 | Not Yet Recruiting

• 1 other identifier: 84771018
• Study Type: observational
• Target: 500
• Locations: 0 countries
• Sites: N/A

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

Keywords

Schizophrenia

Outcome Measures

Primary Outcomes (2)

• Number of patients who decide to participate in a schizophrenia research

  3 months

• Rate of patients who remain in schizophrenia clinical trial to trial completion

  12 month

Eligibility Criteria

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

Study Population

Schizophrenia patients who are actively considering enrolling in an observational clinical trial, but have not yet completed enrollment and randomization.

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Power Life Sciences Inc.: lead

Related Publications (3)

• 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.

  PMID: 21514794 BACKGROUND

• 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.

  PMID: 23256986 BACKGROUND

• 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.

  PMID: 27633376 BACKGROUND

MeSH Terms

Conditions

Schizophrenia

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Study Officials

• Michael B Gill

  Power Life Sciences Inc.

  STUDY DIRECTOR

Central Study Contacts

Michael B Gill

CONTACT

4159004227; 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 12, 2023
• First Posted: May 23, 2023
• Study Start: June 1, 2024
• Primary Completion: June 1, 2025
• Study Completion (Estimated): June 1, 2026
• Last Updated: May 23, 2023

Record last verified: 2023-05