Condition category
Mental and Behavioural Disorders
Date applied
10/02/2010
Date assigned
14/04/2010
Last edited
14/04/2010
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Michael Paulzen

ORCID ID

Contact details

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

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

http://www.ctc-a.de

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

Publication citations

Additional files

Editorial Notes