2024-511433-35-00CompletedPhase 2
EVALUATION OF THE EFFICACY OF TOLCAPONE AS A GENOTYPE-BASED TARGETED COGNITIVE ENHANCER IN SCHIZOPHRENIA, BASED ON THE POLYMORPHISM RS4680
Source: EU CTIS (euclinicaltrials.eu) · Last updated 14 May 2024
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 20 (actual)
- First submitted
- 25 Apr 2024
- Start date
- 8 Sept 2014
- Lead sponsor
- Clinica Universidad De Navarra
- Diseases
- Schizophrenia
- EU CT number
- 2024-511433-35-00
- EudraCT number
- 2010-024119-15
What you commit to
- Study type: Interventional · Phase 2
- Participants enrolled: 20
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of EU CTIS (euclinicaltrials.eu). It describes the study design.
Who cannot take part
Copied verbatim from EU CTIS (euclinicaltrials.eu) and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Participation in another clinical trial in the previous 30 days.
- 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
Other illness
- 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
- 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
Lab values
- 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.
Other
- 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.
Who the study is looking for
- 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.
Age in the registry: 18 years to 64 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Clínica Universidad de navarra | Pamplona | Spain | Completed |
This page is information, not medical advice. Discuss any trial with your doctor.