Hormonal and Inflammatory Biomarkers and Response to Cognitive Remediation in Recent-onset Psychosis (NCT04418570) | Clinical Trial Compass
CompletedNot Applicable
Hormonal and Inflammatory Biomarkers and Response to Cognitive Remediation in Recent-onset Psychosis
28 participantsStarted 2016-07
Plain-language summary
This study aims to explore whether hormones or inflammatory markers are associated with cognitive changes following cognitive remediation therapy (CRT) in people with a recent-onset psychotic disorder.
The following biomarkers for treatment response will be considered: hormones related to the hypothalamic-pituitary-adrenal (HPA) axis (plasma cortisol, cortisol awakening response, diurnal cortisol slope, salivary cortisol at assessment), free thyroxine (F-T4), prolactin, or inflammatory markers.
This study was designed as a pilot clinical trial in order to know the feasibility of the intervention and to calculate the effect sizes of different hormonal and inflammatory variables on cognition. This approach would allow the design of future larger clinical trials to test specific hypotheses generated with this study.
Who can participate
Age range
18 Years – 40 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Psychotic disorder meeting Diagnostic and Statistical Manual of Mental Disorders - 4th edition (DSM-IV) criteria for any of the following diagnoses: schizophrenia, schizoaffective disorder, bipolar disorder, and psychotic disorder not otherwise specified.
* Recent-onset psychosis (\< 3 years of illness).
* Outpatients with stable illness (\<4 points in each positive item of the Positive and Negative Syndrome Scale \[PANSS\]).
* Being on community treatment for at least 4 weeks.
Exclusion Criteria:
* Refusal to participate.
* Severe neurological disease or intellectual disability.
* Pregnancy.
* Substance-induced psychosis.
* History of severe traumatic brain injury.
* Current treatment with glucocorticoids.
* Visual deficits or language difficulties that could influence cognitive assessment and intervention.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.