Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
2008-006905-18
Study information
Scientific title
Pharmacotherapy of cognitive deficits in schizophrenic disorders: a randomised placebo-controlled double-blind study of tolcapone versus pergolide
Acronym
TOCTAP
Study hypothesis
Cognition in patients with schizophrenia is enhanced using pro-cognitive drugs like pergolide or tolcapone compared to placebo.
Ethics approval
Ethics Committee of the Medical Faculty RWTH Aachen University approved on the 14th January 2010
Study design
Double-blind randomised placebo-controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Schizophrenia, cognitive functions
Intervention
TOCTAP 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 type
Drug
Phase
Phase IV
Drug names
Pergolide, tolcapone
Primary outcome measures
Change in Matrics Consensus Cognitive Battery (MCCB), tested at baseline and after a treatment period of six weeks
Secondary outcome measures
Improvement of clinical outcome regarding schizophrenic symptoms, tested at baseline and after a treatment period of six weeks
Overall trial start date
01/04/2010
Overall trial end date
01/10/2011
Reason abandoned
Eligibility
Participant inclusion criteria
1. 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
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
60
Participant exclusion criteria
1. 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
Recruitment start date
01/04/2010
Recruitment end date
01/10/2011
Locations
Countries of recruitment
Germany
Trial participating centre
Universitätsklinikum Aachen
Aachen
52074
Germany
Sponsor information
Organisation
RWTH Aachen University (Germany)
Sponsor details
represented by the CTC-A (clinical trials centre Aachen)
Pauwelsstrasse 30
Aachen
52074
Germany
ctc-a@ukaachen.de
Sponsor type
University/education
Website
Funders
Funder type
Research council
Funder name
RWTH Aachen University (Germany) - funding from local medical faculty
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
German Research Council (Deutsche Forschungsgemeinschaft [DFG]) (Germany)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary