A randomized, double-blind, placebo-controlled study of tetrabenazine as adjunctive therapy to risperidone in first-episode schizophrenia

• Conditions: Schizophrenia; MedDRA version: 9.1Level: LLTClassification code 10039626Term: Schizophrenia

• Registration Number: EUCTR2009-011594-33-DE
• Lead Sponsor: WL University Hospital Bochum, Ruhr-University Bochum

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2009-10-06
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 0

Inclusion Criteria

· male and female patients, 18 to 45 years of age
· diagnosis of schizophrenia as defined in Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV) and confirmed by the Mini-International Neuropsychiatric Interview (M.I.N.I.)
· female patients must test negative for pregnancy and, if of childbearing potential, must be using a medically accepted means of contraception
· patients in whom a minimum in-patient hospitalisation stay of at least 7 weeks (when enrolled in the study) is acceptable, in the clinical judgement of the investigator
· patients must be considered reliable, have a level of understanding sufficient to perform all tests and examinations required by the protocol
· patients must be able to understand the nature of the study and have given their own informed consent
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
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

· patients in whom treatment with risperidone, tetrabenazine, or placebo is relatively or absolutely clinically contraindicated
· patients who have received an experimental drug or used an experimental medical device for any indication within 30 days prior to Visit 1
· patients who have a history of inadequate response to an adequate treatment with risperidone, in the opinion of the investigator
· patients who have received treatment with risperidone within 6 weeks prior to Visit 1
· patients who have a history of an inadequate response, in the opinion of the investigator, to 2 or more adequate antipsychotic medication trials of at least 8 weeks duration in the past 12 months prior to Visit 1
· patients who require concomitant treatment with any other medication with primary central nervous system activity, other than benzodiazepines and anticholinergics
· patients who receive treatment with depot antipsychotic medication within 1 dosing interval, minimum of 4 weeks, prior to Visit 1
· patients who have received treatment with clozapine at doses greater than 200 mg daily within 12 months prior to Visit 1, or who have received any clozapine at all during the month before Visit 1
· patients at risk of suicide (e.g. history of any suicide attempts, any current suicidal intent including plan)
· DSM-IV diagnosis of substance dependence (except nicotine and caffeine)
· DSM-IV diagnosis of substance-induced psychosis within 7 days of Visit 1
· female patients who are pregnant, nursing, or who intend to become pregnant within 30 days of completing the study
· aminotransferase levels > 2 times upper limit of normal (ULN) at Visit 1
· prolactin level > 200 ng/ml at Visit 1
· thyroid-stimulating hormone (TSH) > 10% above the ULN at Visit 1
· clinically significant ECG abnormalities at Visit 1
· patients with acute, serious, or unstable medical conditions
· employees of the investigator or study center, with direct involvement in the proposed study or other studies under the direction of that investigator or study center, as well as family members of the employees or the investigator

Study & Design

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