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EVALUATION OF THE EFFICACY OF TOLCAPONE AS A GENOTYPE-BASED TARGETED COGNITIVE ENHANCER IN SCHIZOPHRENIA, BASED ON THE POLYMORPHISM RS4680
EU CTIS ID: 2024-511433-35-00
What this study is testing
To objectify the efficacy of Tolcapone, depending on the genotype for the rs4680 polymorphism of the COMT enzyme gene, to improve cognitive impairment and negative symptoms in patients with long-standing schizophrenia, in the clinical compensation phase.
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Ability to provide informed consent and express your desire to comply with all protocol requirements during the study period.
- The patient must, in the opinion of the investigator, be able to comply with all the requirements of the clinical trial.
- Age between 18-65 years.
- Patients diagnosed with schizophrenia according to DSM-5. Only chronic patients will be recruited (disease duration greater than or equal to 5 years) and, in order to obtain informed consent for participation in this study, all patients must be in the clinical compensation phase at the time of recruitment. The determination of clinical compensation will be made according to these criteria: i) patients receiving treatment on an outpatient basis, with no hospitalization due to acute psychiatric decompensation during the previous year, and ii) score on the Global Activity Assessment Scale (GAF) maintained equal to or greater than 60 during the last month. The recruitment process will include a clinical interview to verify the diagnosis.
- Caucasian origin
- In the case of a woman of childbearing age, a negative pregnancy test.
You likely can't join if
- Infections or serious diseases or kidney or spinal cord failure that discourage the patient's participation in the study, according to the researcher's criteria
- Participation in another clinical trial in the previous 30 days.
- Other situations that imply contraindications for Tasmar® (Tolcapone): History of neuroleptic malignant syndrome or non-traumatic rhabdomyolysis or malignant hyperthermia. Severe dyskinesia. Pheochromocytoma. Hereditary lactose or galactase intolerance. Lapp lactase deficiency or glucose or galactose malabsorption.
- Liver alterations (increase in liver enzymes above normal values) that discourage the patient's participation in the study, according to the investigator's criteria
- Positive pregnancy test, or breastfeeding women
- Being a wearer of any metal prosthesis or pacemaker incompatible with performing nuclear magnetic resonance.
See the full eligibility criteria
Who can join
- Ability to provide informed consent and express your desire to comply with all protocol requirements during the study period.
- The patient must, in the opinion of the investigator, be able to comply with all the requirements of the clinical trial.
- Age between 18-65 years.
- Patients diagnosed with schizophrenia according to DSM-5. Only chronic patients will be recruited (disease duration greater than or equal to 5 years) and, in order to obtain informed consent for participation in this study, all patients must be in the clinical compensation phase at the time of recruitment. The determination of clinical compensation will be made according to these criteria: i) patients receiving treatment on an outpatient basis, with no hospitalization due to acute psychiatric decompensation during the previous year, and ii) score on the Global Activity Assessment Scale (GAF) maintained equal to or greater than 60 during the last month. The recruitment process will include a clinical interview to verify the diagnosis.
- Caucasian origin
- In the case of a woman of childbearing age, a negative pregnancy test.
What rules you out
- Infections or serious diseases or kidney or spinal cord failure that discourage the patient's participation in the study, according to the researcher's criteria
- Participation in another clinical trial in the previous 30 days.
- Other situations that imply contraindications for Tasmar® (Tolcapone): History of neuroleptic malignant syndrome or non-traumatic rhabdomyolysis or malignant hyperthermia. Severe dyskinesia. Pheochromocytoma. Hereditary lactose or galactase intolerance. Lapp lactase deficiency or glucose or galactose malabsorption.
- Liver alterations (increase in liver enzymes above normal values) that discourage the patient's participation in the study, according to the investigator's criteria
- Positive pregnancy test, or breastfeeding women
- Being a wearer of any metal prosthesis or pacemaker incompatible with performing nuclear magnetic resonance.
- History of hypersensitivity to Tasmar® (Tolcapone) or any of its components.
- Current history (in the last 12 months) of substance abuse or existence of another illness that justifies the appearance of psychiatric symptoms
- Cardiovascular disease and clinically relevant ECG alteration
- Patients who, during the study or up to 15 days before starting the study, receive or have received treatment with MAOIs
- Patients receiving treatment with a COMT inhibitor
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.