Evaluating tolcapone for improving cognition in schizophrenia
Evaluation of the Efficacy of Tolcapone as a Genotype-based Targeted Cognitive Enhancer in Schizophrenia, Based on the Polymorphism rs4680
PHASE2 · Clinica Universidad de Navarra, Universidad de Navarra · NCT06387771
This study is testing if a medication called tolcapone can help improve thinking skills in people with schizophrenia who have a specific genetic makeup.
Quick facts
| Phase | PHASE2 |
|---|---|
| Study type | Interventional |
| Enrollment | 20 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | Clinica Universidad de Navarra, Universidad de Navarra (other) |
| Locations | 1 site (Pamplona, Navarra) |
| Trial ID | NCT06387771 on ClinicalTrials.gov |
What this trial studies
This study aims to assess the efficacy of tolcapone as a cognitive enhancer in patients with schizophrenia, focusing on those with specific genetic profiles. A total of 20 chronic and stabilized schizophrenia patients will be enrolled, divided into two groups based on the rs4680 polymorphism genotype. Participants will receive tolcapone for 7 days, with cognitive function and clinical status evaluated through neuropsychological tests and fMRI imaging before and after treatment. The hypothesis is that only patients with the Val/Val genotype will show cognitive improvements and enhanced prefrontal cortex activation.
Who should consider this trial
Good fit: Ideal candidates are chronic schizophrenia patients with the Val/Val genotype of the rs4680 polymorphism.
Not a fit: Patients with the Met/Met genotype or those not meeting the inclusion criteria may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly improve cognitive function and reduce negative symptoms in patients with schizophrenia who have the Val/Val genotype.
How similar studies have performed: While studies on cognitive enhancers in schizophrenia exist, this genotype-targeted approach is relatively novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Ability to give informed consent and express the wish to fulfill all the requirements of the protocol during the study period. * The patient must be capable of fulfillment of all the requirements of the clinical trial, at the investigator's discretion. * Patients diagnosed with schizophrenia according to the Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5). Only chronic patients will be recruited, and they must be clinically compensated in order to consent to participate. The determination of clinical compensation will be conducted according with these criteria: i) outpatients, with absence of hospitalization due to acute psychiatric decompensation in the previous year, and ii) maintained GAF score equal or higher than 60 during the previous month. The recruitment process will include a clinical interview to verify the diagnosis. * Caucasic ethnicity * Negative pregnancy test for women of childbearing age. Exclusion Criteria: * Severe infections or diseases or hepatic failure (or increased liver enzymes), renal failure or bone marrow failure that advise against participation in the study at the investigator's discretion * Positive pregnancy test, or breastfeeding women. * Carriers of pacemaker or any kind of metallic prosthesis incompatible with magnetic resonance imaging. * History of hypersensitivity to Tasmar® (tolcapone) or to any of its components * Active (in the last 12 months) substance abuse, or other disease that causes psychiatric symptoms * Cardiovascular disease and electrocardiogram alterations * Patients receiving treatment with monoamine oxidase inhibitors during the study or up to 15 days prior to the beginning of the study. * Patients receiving treatment with a catechol-O-methyltransferase (COMT) inhibitor * Participation in another clinical trial in the previous 30 days. * Other circumstances which involve Tasmar® (tolcapone) contraindications: history of Neuroleptic Malignant Syndrome and/or non-traumatic rhabdomyolysis or hyperthermia. Severe dyskinesia. Phaeochromocytoma. Hereditary galactose intolerance. Lapp lactase deficiency or glucose or galactose malabsorption.
Where this trial is running
Pamplona, Navarra
- Clinica Universidad de Navarra — Pamplona, Navarra, Spain (RECRUITING)
Study contacts
- Principal investigator: Patricio Molero, MD, PhD — Clinica Universidad de Navarra
- Study coordinator: Jose Maria Galindo
- Email: ucicec@unav.es
- Phone: 34 948 255400
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Schizophrenia, Cognition, Pharmacogenetics, fMRI