SchizophreniaNCT05870722
An In Depth Study Evaluating The Experiences of Patients In Schizophrenia Research
An observational study of Schizophrenia, run by Power Life Sciences Inc..
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Schizophrenia
- How many people
- 500 participants
- Where
- No sites listed yet
- Study dates
- Jun 2024to Jun 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Schizophrenia patients who are actively considering enrolling in an observational clinical trial, but have not yet completed enrollment and randomization.
Who may be able to join
- 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
Who cannot join
- Patient does not understand, sign, and return consent form
- Inability to perform regular electronic reporting
- Patient is pregnant
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Pinpointing the Factors Affecting Clinical Study Experiences of Schizophrenia Patients
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
- Medical subject headings
- Schizophrenia
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients who decide to participate in a schizophrenia research
Measured: 3 months
Rate of patients who remain in schizophrenia clinical trial to trial completion
Measured: 12 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 May 2023
- Study startJun 2024 (estimated)
- Primary completionJun 2025 (estimated)
- Study completionJun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for SchizophreniaStudies of the same condition, open and under way.
- More trials run by Power Life Sciences Inc.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case crossover
- Time perspective
- Prospective
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Power Life Sciences Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Michael B Gill, Study director, Power Life Sciences Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05870722
- Sponsor's protocol ID
- 84771018
- Status last verified
- May 2023
- First submitted
- 12 May 2023
- Last updated
- 23 May 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 21514794Kishimoto 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.
PubMed 23256986Maric 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.
PubMed 27633376
Study at a glance
From the registry record, last updated by the sponsor on 23 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pinpointing the Factors Affecting Clinical Study Experiences of Schizophrenia Patients
- ClinicalTrials.gov ID
- NCT05870722
- Acronym / sponsor ID
- 84771018
- Conditions
- Schizophrenia
- Keywords
- Schizophrenia
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Power Life Sciences Inc.Industry (pharma, biotech, devices)
- Study start
- Jun 2024 (estimated)
- Primary completion
- Jun 2025 (estimated)
- Study completion
- Jun 2026 (estimated)
- First posted
- 23 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case crossover
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Schizophrenia patients who are actively considering enrolling in an observational clinical trial, but have not yet completed enrollment and randomization.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (3 listed)
- Patient does not understand, sign, and return consent form
- Inability to perform regular electronic reporting
- Patient is pregnant
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Number of patients who decide to participate in a schizophrenia research
Time frame: 3 months
Rate of patients who remain in schizophrenia clinical trial to trial completion
Time frame: 12 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 May 2023.
- Background: PubMed 21514794Barnett 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.
- Background: PubMed 23256986Kishimoto 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.
- Background: PubMed 27633376Maric 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael B Gill study director
Power Life Sciences Inc.
Questions about this trial
What is this clinical trial studying?
An observational study of Schizophrenia, run by Power Life Sciences Inc..
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 23 May 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Michael B Gill (4159004227, bask@withpower.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of patients who decide to participate in a schizophrenia research (time frame: 3 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05870722, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 May 2023.