Assessment of Schizophrenia Patients' Clinical Study Experiences

NCT ID: NCT05948111

Last Updated: 2023-07-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Total Enrollment

500 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-08-31

Study Completion Date

2026-08-31

Brief Summary

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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.

Detailed Description

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Conditions

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Schizophrenia

Study Design

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Observational Model Type

CASE_CROSSOVER

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Power Life Sciences Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Michael B Gill

Role: STUDY_DIRECTOR

Power Life Sciences Inc.

Locations

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Power Life Sciences

San Francisco, California, United States

Site Status

Countries

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United States

Central Contacts

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Michael B Gill

Role: CONTACT

(415) 900-4227

Facility Contacts

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Michael B Gill

Role: primary

References

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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.

Reference Type BACKGROUND
PMID: 33887648 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 35219052 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 34986711 (View on PubMed)

Provided Documents

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Document Type: Informed Consent Form

View Document

Other Identifiers

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83338153

Identifier Type: -

Identifier Source: org_study_id

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