Treatment Of Cognitive deficits in schizophrenia with Tolcapone And Pergolide
| ISRCTN | ISRCTN42412532 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN42412532 |
| Secondary identifying numbers | 2008-006905-18 |
- 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
Scientific
Universitätsklinikum Aachen
Klinik für Psychiatrie und Psychotherapie
Pauwelsstr. 30
Aachen
52074
Germany
Study information
| Study design | Double-blind randomised placebo-controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | Pharmacotherapy of cognitive deficits in schizophrenic disorders: a randomised placebo-controlled double-blind study of tolcapone versus pergolide |
| Study acronym | TOCTAP |
| Study objectives | Cognition 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) studied | 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 |
| Pharmaceutical study type(s) | |
| Phase | Phase IV |
| Drug / device / biological / vaccine name(s) | Pergolide, tolcapone |
| Primary outcome measure | 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 study start date | 01/04/2010 |
| Completion date | 01/10/2011 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 60 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 01/04/2010 |
| Date of final enrolment | 01/10/2011 |
Locations
Countries of recruitment
- Germany
Study participating centre
Universitätsklinikum Aachen
Aachen
52074
Germany
52074
Germany
Sponsor information
RWTH Aachen University (Germany)
University/education
University/education
represented by the CTC-A (clinical trials centre Aachen)
Pauwelsstrasse 30
Aachen
52074
Germany
| ctc-a@ukaachen.de | |
| Website | http://www.ctc-a.de |
"ROR" |
https://ror.org/04xfq0f34 |
Funders
Funder type
Research council
RWTH Aachen University (Germany) - funding from local medical faculty
No information available
German Research Council (Deutsche Forschungsgemeinschaft [DFG]) (Germany)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
