Treatment Of Cognitive deficits in schizophrenia with Tolcapone And Pergolide

ISRCTN ISRCTN42412532
DOI https://doi.org/10.1186/ISRCTN42412532
Protocol serial number 2008-006905-18
Sponsor RWTH Aachen University (Germany)
Funders RWTH Aachen University (Germany) - funding from local medical faculty, German Research Council (Deutsche Forschungsgemeinschaft [DFG]) (Germany)
Submission date
10/02/2010
Registration date
14/04/2010
Last edited
14/04/2010
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Mental and Behavioural Disorders
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Michael Paulzen
Scientific

Universitätsklinikum Aachen
Klinik für Psychiatrie und Psychotherapie
Pauwelsstr. 30
Aachen
52074
Germany

Study information

Primary study designInterventional
Study designDouble-blind randomised placebo-controlled trial
Secondary study designRandomised controlled trial
Study type Participant information sheet
Scientific titlePharmacotherapy of cognitive deficits in schizophrenic disorders: a randomised placebo-controlled double-blind study of tolcapone versus pergolide
Study acronymTOCTAP
Study objectivesCognition in patients with schizophrenia is enhanced using pro-cognitive drugs like pergolide or tolcapone compared to placebo.
Ethics approval(s)Ethics Committee of the Medical Faculty RWTH Aachen University approved on the 14th January 2010
Health condition(s) or problem(s) studiedSchizophrenia, cognitive functions
InterventionTOCTAP is a randomised, three-armed double-blind study with 60 patients suffering from schizophrenia, using DSM-IV diagnostic criteria. Patients are randomised in three groups of 20 patients each. Patients either receive 300 mg of tolcapone (100 mg - 100 mg - 100 mg) or 0.30 mg of pergolide (0.25 mg - 0.05 mg - 0.00 mg) or placebo three times daily (TID). Cognitive function is tested using the MATRICS Consensus Cognitive Battery (MCCB) at baseline and after a period of six weeks of pro-cognitive medication.
Intervention typeDrug
PhasePhase IV
Drug / device / biological / vaccine name(s)Pergolide, tolcapone
Primary outcome measure(s)

Change in Matrics Consensus Cognitive Battery (MCCB), tested at baseline and after a treatment period of six weeks

Key secondary outcome measure(s)

Improvement of clinical outcome regarding schizophrenic symptoms, tested at baseline and after a treatment period of six weeks

Completion date01/10/2011

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit18 Years
SexAll
Target sample size at registration60
Key inclusion criteria1. 60 patients suffering from schizophrenia using Diagnostic and Statistical Manual of Mental Disorders, 4th Edition (DSM-IV) criteria
2. Signed informed consent
3. Aged 18 - 55 years, either sex
4. Negative pregnancy test
5. No drug addiction
6. No suicidality
7. Ability to understand and read German language
Key exclusion criteria1. Drug addiction
2. Severe medical problems
3. Long-QT-syndrome
4. Problems regarding the heart-valves
5. Seizures
6. Reduced liver or renal function
7. Pregnancy
8. Known incompatibility of the study-drugs
Date of first enrolment01/04/2010
Date of final enrolment01/10/2011

Locations

Countries of recruitment

  • Germany

Study participating centre

Universitätsklinikum Aachen
Aachen
52074
Germany

Results and Publications

Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Participant information sheet Participant information sheet 11/11/2025 11/11/2025 No Yes
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