Effectiveness of tolcapone in schizophrenia

• Conditions: schizophrenia; MedDRA version: 16.1Level: HLGTClassification code 10039628Term: Schizophrenia and other psychotic disordersSystem Organ Class: 10037175 - Psychiatric disorders; Therapeutic area: Psychiatry and Psychology [F] - Mental Disorders [F03]

• Registration Number: EUCTR2013-002713-35-GR
• Lead Sponsor: MediPsych SA

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2014-04-25
• Last Update Posted: 27 October 2014

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

A patient must meet all the following criteria to be eligible for this study:
1. The patients will be male or female, aged from 18 to 65 years old.
2. The patient is willing and able to provide signed informed consent form. For patients in acute relapse, legal representatives will be required to sign the consent form.
3. The patient will have an official diagnosis of Schizophrenia or Schizoaffective disorder according to the DSM-IV TR criteria and will display the cognitive and negative symptoms of schizophrenia.
4. The patient will be either at relapse of the disorder (Group 1) or at the early stages of the disease and/or stabilised (Group 2) and takes standard antipsychotic medication.
5. If the patient is sexually active, then s/he must satisfy one of the following criteria:
a) For Women: They should not be pregnant or be in lactation period. They should be either surgically sterilized or be in postmenopausal period. The patient’ partner should apply an accepted and highly effective contraceptive regimen (a shape which leads to failure rate < 1%) for 4 weeks before the preliminary assessment.
b) For Men: They should be either surgically sterilized or patient or patient’partner should use an accepted and highly effective method of contraception during administration and for 4 weeks after the last dose of research product.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 100
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

A patient who meets any of the following criteria will be excluded from this study.
1. The patient is hypersensitive to tolcapone.
2. The patient has hereditary problems of galactose intolerance, Lapp lactose deficiency or glucose - galactose malabsorption.
3. The patient suffers from severe physical and neurological active disease and /or present history of Neuroleptic Malignant Syndrome.
4. The patient is suffering from liver dysfunction and / or increased liver enzymes (serum alanine aminotransferase (ALT) and / or aspartamikis aminotransferase (AST) = 1,5 x ULN)
5. The patient suffers from severe renal impairment (creatinine clearance <30 ml / min)
6. The patient suffers from epilepsy
7. The patient is suffering from severe dyskinesia and/or from non - traumatic Rhabdomyolysis or Hyperthermia.
8. The patient is suffering from pheochromocytoma.
9. The patient has a previous history of Neuroleptic Malignant Syndrome (NMS).
10. The patient has suffered a myocardial infarction within the last 6 months.
11. The patient receives treatment with non - selective inhibitors of mono - amino - oxidase (MAO) inhibitors (eg phenelzine and tranylcypromine). If the patient is treated with a selective inhibitor of MAO –B, it should not exceed the recommended dose (eg for selegiline < 10mg/day) when co-administered with tolcapone .
12. The patient receives other enzyme inhibitor COMT drugs (e.g. entacapone, clozapine) or other dopaminergic drugs.
13. The patient is being treated with levodopa and benserazide.
14. The patient receives or has received in the past another investigational drug, biologic or device within 4 weeks of the preliminary assessment.
15. The patient receives antipsychotic medication known to exclude D1 receptors with high binding (affinity) such as flupenthixol , fluphenazine , ziprasidone , chlorpromazine , and olanzapine (Ki 4, 6, 30, 35 and 48 respectively).
16. The patient according to the investigator is unable to meet the requirements of the study.
17. The patient has a current or recent history of drug or alcohol or shows reluctance to decrease the consumption of alcohol.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified