Schizophrenia Clinical Trial
Official title:
Insights From Participants: Candid Accounts of Schizophrenia Clinical Trials Patients
| NCT number | NCT05948111 |
| Other study ID # | 83338153 |
| Secondary ID | |
| Status | Not yet recruiting |
| Phase | |
| First received | |
| Last updated | |
| Start date | August 2024 |
| Est. completion date | August 2026 |
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.
| Status | Not yet recruiting |
| Enrollment | 500 |
| Est. completion date | August 2026 |
| Est. primary completion date | August 2025 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility | 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 |
| Country | Name | City | State |
|---|---|---|---|
| United States | Power Life Sciences | San Francisco | California |
| Lead Sponsor | Collaborator |
|---|---|
| Power Life Sciences Inc. |
United States,
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. — View 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. — View 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. — View Citation
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Number of schizophrenia patients who decide to enroll in a clinical trial | 3 months | ||
| Primary | Rate of schizophrenia patients who remain in clinical trial to trial completion | 12 months |
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