Clinical trial NCT05948111: Assessment of Schizophrenia Patients' Clinical Study Experiences
Official title: Insights From Participants: Candid Accounts of Schizophrenia Clinical Trials Patients
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Schizophrenia
Keywords: Schizophrenia
Lead sponsor: Power Life Sciences Inc.
Sponsor class: INDUSTRY
First posted: 2023-07-17
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CROSSOVER
Time perspective: PROSPECTIVE
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.

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.


Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Number of schizophrenia patients who decide to enroll in a clinical trial
timeFrame: 3 months
measure: Rate of schizophrenia patients who remain in clinical trial to trial completion
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: Power Life Sciences
state: California
Study officials:
affiliation: Power Life Sciences Inc.
name: Michael B Gill
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.
citation: 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.