Assessment of Schizophrenia Patients' Clinical Study Experiences

NCT05948111 | Not Yet Recruiting

• 1 other identifier: 83338153
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 1

Brief Summary

The study seeks to delve into the firsthand experiences of patients diagnosed with schizophrenia who partake in a separate clinical trial featuring a specific medical intervention. The primary emphasis will be on meticulously tracking the rates of trial completion and withdrawal among these individuals. The data collected from this study will help improve future outcomes for all schizophrenia patients as well as those in under-represented demographic groups.

Conditions

Schizophrenia

Keywords

Schizophrenia

Outcome Measures

Primary Outcomes (2)

• Number of schizophrenia patients who decide to enroll in a clinical trial

  3 months

• Rate of schizophrenia patients who remain in clinical trial to trial 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 with schizophrenia who are actively considering enrolling in an observational clinical study for said condition, but have not yet completed enrollment and randomization phases.

You may qualify if:

• Diagnosis of schizophrenia
• Considered reliable, able to understand, and willing to perform all study procedures
• Signed Written Informed Consent

You may not qualify if:

• Currently enrolled in, have completed or have discontinued from a clinical trial involving an investigational drug
• Is pregnant, breastfeeding or expecting to conceive within the projected duration of the study
• Any serious and/or unstable pre-existing medical disorders

Sponsors & Collaborators

• Power Life Sciences Inc.: lead

Study Sites (1)

Power Life Sciences

San Francisco, California, 94107, United States

Location

Related Publications (3)

• Runge K, Fiebich BL, Kuzior H, Saliba SW, Yousif NM, Meixensberger S, Nickel K, Denzel D, Schiele MA, Maier SJ, Berger B, Dersch R, Domschke K, Tebartz van Elst L, Endres D. An observational study investigating cytokine levels in the cerebrospinal fluid of patients with schizophrenia spectrum disorders. Schizophr Res. 2021 May;231:205-213. doi: 10.1016/j.schres.2021.03.022. Epub 2021 Apr 19.

  PMID: 33887648 BACKGROUND

• Srisurapanont M, Kunchanaphongphan T, Chokemaitree N, Prachason T, Kanchanatawan B, Suttajit S, Sanguanvichaikul T, Trisukon W, Dendumrongkul P, Chinvararak C, Kawilapat S. Course and predictors of disability in Thai patients with schizophrenia: A 2-year, multi-center, prospective, observational study. Asian J Psychiatr. 2022 Apr;70:103044. doi: 10.1016/j.ajp.2022.103044. Epub 2022 Feb 19.

  PMID: 35219052 BACKGROUND

• Garcia-Portilla MP, Benito Ruiz A, Gomez Robina F, Garcia Dorado M, Lopez Rengel PM. Impact on functionality of the paliperidone palmitate three-month formulation in patients with a recent diagnosis of schizophrenia: a real-world observational prospective study. Expert Opin Pharmacother. 2022 Apr;23(5):629-638. doi: 10.1080/14656566.2021.2023496. Epub 2022 Jan 5.

  PMID: 34986711 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

(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: July 7, 2023
• First Posted: July 17, 2023
• Study Start: August 1, 2024
• Primary Completion: August 1, 2025
• Study Completion (Estimated): August 1, 2026
• Last Updated: July 17, 2023

Record last verified: 2023-07

Locations

US (1)