SchizophreniaPhase 2NCT06387771
Evaluation of Tolcapone as a Cognitive Enhancer in Schizophrenia
A Phase 2 study testing Tolcapone in people with Schizophrenia, run by Clinica Universidad de Navarra, Universidad de Navarra at 1 site in Spain.
Trial summary
Objective: To assess the efficacy of tolcapone to improve cognition in schizophrenia, as a genotype-based targeted treatment of cognitive and negative symptoms of schizophrenia considering the polymorphism rs4680. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Schizophrenia
- What is being tested?
- Tolcapone
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteSpain
- Study dates
- 22 Sep 2014to Aug 2025
- Phase
- Phase 2
- 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
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- 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.
Trial locations and contacts
1 site in 1 country.
Spain1 site, 1 recruiting
- Recruiting
Clinica Universidad de Navarra
Pamplona, Navarre, 31008
Jose Maria Galindo, 34 948 255400 ext. 2725, ucicec@unav.es
About this study
Official title: Evaluation of the Efficacy of Tolcapone as a Genotype-based Targeted Cognitive Enhancer in Schizophrenia, Based on the Polymorphism rs4680
Objective: To assess the efficacy of tolcapone to improve cognition in schizophrenia, as a genotype-based targeted treatment of cognitive and negative symptoms of schizophrenia considering the polymorphism rs4680.
Methodology: 20 patients with chronic and stabilized schizophrenia (10 patients with genotype Val/Val and 10 patients with genotype Met/Met according to polymorphism rs4680) will receive treatment with tolcapone during 7 days. The cognitive function and clinical status will be evaluated with a neuropsychological battery and appropriate clinical scales before and after treatment. The efficiency of the activation of the prefrontal cortex will be measured using functional magnetic resonance imaging (fMRI) before and after treatment.
Hypothesis: Only patients with genotype Val/Val treated with tolcapone would show a cognitive improvement, a higher efficiency of the activation of the prefrontal cortex and an amelioration of some negative symptoms.
- Conditions
- Schizophrenia
- Being tested
- Tolcapone
- Keywords
- Schizophrenia, Cognition, Pharmacogenetics, fMRI
- Medical subject headings
- Schizophrenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TolcaponeDrug
Tolcapone (Film-coated tablet) 200 mg orally every 8 hours for 7 days
| Study group | Role | What they receive |
|---|---|---|
| Tolcapone | Experimental | Tolcapone (Film-coated tablet) 200 mg orally every 8 hours for 7 days Receives: Drug: Tolcapone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy: Change from baseline in cognitive test scores at day 8
Performance in the cognitive tests scores: Dot Pattern Expectancy Task and cognitive tests (including subtests of the MATRICS* battery) (*MATRICS=Measurement and Treatment Research to Improve Cognition in Schizophrenia cognitive battery established by the National Institute of Mental Health) .
Measured: Day 8
Efficacy: Change from baseline in the brain blood-oxygen-level-dependent (BOLD) response at day 8
Elicited brain activation during functional magnetic resonance neuroimaging (relative degree of activation of different brain regions) measured by BOLD signal.
Measured: Day 8
Secondary outcomes (9)
Efficacy: change from baseline in psychotic symptoms intensity measured by the PANSS scores at day 8
Change in psychotic symptoms intensity measured by the PANSS symptom scores
Measured: Day 8
Efficacy: negative symptoms intensity: change from baseline in the 16-item Negative Symptom Assessment (NSA-16) scale scores at day 8
Change in negative symptoms intensity measured by the NSA-16 scale
Measured: Day 8
Efficacy: change from baseline in the intensity of psychotic symptoms measured by the Brief Psychiatric Rating Scale (BPRS) scores at day 8
Clinical outcome measured by the change in the scores on the BPRS
Measured: Day 8
Efficacy: change from baseline in the clinical global impression measured by the Clinical Global Impression (CGI) scale scores at day 8
Clinical outcome measured by the change in the scores on the CGI scale
Measured: Day 8
Efficacy: change from baseline in the global assessment of functioning measured by the Global Assessment of Functioning (GAF) scale scores at day 8
Clinical outcome measured by the change in the scores on the GAF scale
Measured: Day 8
Efficacy: change from baseline in the anxiety symptoms measured by the Hamilton Anxiety Rating Scale (HAM-A) scale scores at day 8
Clinical outcome measured by the change in the scores on the HAM-A scale
Measured: Day 8
Efficacy: change from baseline in the depressive symptoms measured by the Hamilton Depression Rating Scale (HAM-D) scale scores at day 8
Clinical outcome measured by the change in the scores on the HAM-D scale
Measured: Day 8
Efficacy: change from baseline in the Clinician-Rated Dimensions of Psychosis Symptom Severity (CRDPSS) scale scores at day 8
Clinical outcome measured by the change in the scores on the CRDPSS scale
Measured: Day 8
Change from baseline in plasmatic homocysteine (umol/L)
Clinical outcome measured by the change in homocystinemia (umol/L)
Measured: Day 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2024
- Study start22 Sep 2014
- Primary completionAug 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SchizophreniaStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Clinica Universidad de Navarra, Universidad de Navarra
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Patricio Molero, MD, PhD, Principal investigator, Clinica Universidad de Navarra
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06387771
- Sponsor's protocol ID
- rs4680-tolcapona
- Status last verified
- Feb 2024
- First submitted
- 14 Sep 2015
- Last updated
- 29 Apr 2024
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Efficacy of Tolcapone as a Genotype-based Targeted Cognitive Enhancer in Schizophrenia, Based on the Polymorphism rs4680
- ClinicalTrials.gov ID
- NCT06387771
- Acronym / sponsor ID
- rs4680-tolcapona
- Conditions
- Schizophrenia
- Keywords
- Schizophrenia, Cognition, Pharmacogenetics, fMRI
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Clinica Universidad de Navarra, Universidad de NavarraUniversity, hospital or other
- Study start
- 22 Sep 2014 (actual)
- Primary completion
- Aug 2025 (estimated)
- First posted
- 29 Apr 2024 (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.
Objective: To assess the efficacy of tolcapone to improve cognition in schizophrenia, as a genotype-based targeted treatment of cognitive and negative symptoms of schizophrenia considering the polymorphism rs4680.
Methodology: 20 patients with chronic and stabilized schizophrenia (10 patients with genotype Val/Val and 10 patients with genotype Met/Met according to polymorphism rs4680) will receive treatment with tolcapone during 7 days. The cognitive function and clinical status will be evaluated with a neuropsychological battery and appropriate clinical scales before and after treatment. The efficiency of the activation of the prefrontal cortex will be measured using functional magnetic resonance imaging (fMRI) before and after treatment.
Hypothesis: Only patients with genotype Val/Val treated with tolcapone would show a cognitive improvement, a higher efficiency of the activation of the prefrontal cortex and an amelioration of some negative symptoms.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Tolcapone | Experimental | Drug: TolcaponeTolcapone (Film-coated tablet) 200 mg orally every 8 hours for 7 days |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TolcaponeTolcapone (Film-coated tablet) 200 mg orally every 8 hours for 7 days | Drug | Tolcapone |
Primary outcome
Efficacy: Change from baseline in cognitive test scores at day 8
Time frame: Day 8
Performance in the cognitive tests scores: Dot Pattern Expectancy Task and cognitive tests (including subtests of the MATRICS* battery) (*MATRICS=Measurement and Treatment Research to Improve Cognition in Schizophrenia cognitive battery established by the National Institute of Mental Health) .
Efficacy: Change from baseline in the brain blood-oxygen-level-dependent (BOLD) response at day 8
Time frame: Day 8
Elicited brain activation during functional magnetic resonance neuroimaging (relative degree of activation of different brain regions) measured by BOLD signal.
9 secondary outcomes
Efficacy: change from baseline in psychotic symptoms intensity measured by the PANSS scores at day 8
Time frame: Day 8
Efficacy: negative symptoms intensity: change from baseline in the 16-item Negative Symptom Assessment (NSA-16) scale scores at day 8
Time frame: Day 8
Efficacy: change from baseline in the intensity of psychotic symptoms measured by the Brief Psychiatric Rating Scale (BPRS) scores at day 8
Time frame: Day 8
Efficacy: change from baseline in the clinical global impression measured by the Clinical Global Impression (CGI) scale scores at day 8
Time frame: Day 8
Efficacy: change from baseline in the global assessment of functioning measured by the Global Assessment of Functioning (GAF) scale scores at day 8
Time frame: Day 8
Efficacy: change from baseline in the anxiety symptoms measured by the Hamilton Anxiety Rating Scale (HAM-A) scale scores at day 8
Time frame: Day 8
Efficacy: change from baseline in the depressive symptoms measured by the Hamilton Depression Rating Scale (HAM-D) scale scores at day 8
Time frame: Day 8
Efficacy: change from baseline in the Clinician-Rated Dimensions of Psychosis Symptom Severity (CRDPSS) scale scores at day 8
Time frame: Day 8
Change from baseline in plasmatic homocysteine (umol/L)
Time frame: Day 8
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2024.
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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.
Patricio Molero, MD, PhD principal investigator
Clinica Universidad de Navarra
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Tolcapone in people with Schizophrenia, run by Clinica Universidad de Navarra, Universidad de Navarra at 1 site in Spain.
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 5 inclusion and 10 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 29 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Jose Maria Galindo (34 948 255400 ext. 2725, ucicec@unav.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Efficacy: Change from baseline in cognitive test scores at day 8 (time frame: Day 8). 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?
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 29 Apr 2024.