Early versus late initiation of treatment with Risperdal Consta in subjects with schizophrenia or schizoaffective disorder after an acute episode - Risperdal long acting injections after acute psychosis

• Conditions: Schizophrenia or schizoaffective disorder.

• Registration Number: EUCTR2005-002304-41-SE
• Lead Sponsor: Janssen-Cilag EMEA Medical Affairs

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2005-07-29
• Last Update Posted: 12 June 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 220

Inclusion Criteria

male or female subject
subject with an acute episode (maximum time of pre-treatment for the episode: 14 days at randomization)
age >=18 and <=65 years of age
subjects currently not treated or treated with oral antipsychotics or short-acting injectable antipsychotics (zuclopenthixol acutard is allowed) at doses not exceeding the registered dose
female subjects must be surgically sterile, or practicing an effective method of birth control (e.g., prescription oral contraceptives, contraceptive injections, intrauterine device, double-barrier method, contraceptive patch, male partner sterilization, abstinence) before entry and throughout the study; and have a negative urine pregnancy test at trial entry
subjects (or their legally acceptable representatives) must have signed an informed consent document indicating that they understand the purpose of and procedures required for the study and are willing to participate in the study
Subjects eligible for treatment with Risperdal Consta according to the registered indication in the country; diagnosis according to Diagnostic and Statistical Manual of Mental Diseases, Fourth Edition (DSM-IV).
PANSS >=80 at the baseline visit
CGI-S >=5 at the baseline visit
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

DSM-IV axis I diagnosis other than schizophrenia or schizoaffective disorder
subjects being treated for the acute episode more than 14 days prior to randomization
subjects treated with clozapine during the lats two months before randomization or a conventional depot antipsychotic in the last 4 weeks prior to randomization (zuclopenthixol acutard is accepted as acute treatment)
subjects who are known non-responders to risperidone proven by adequate drug plasma levels (non-responders due to non-compliance are not excluded)
evidence of alcohol or drug abuse or dependence (except for nicotine and caffeine dependence) according to DSM-IV criteria diagnosed in the last month prior to entry
pregnant or breast-feeding females
have received an experimental drug or used an experimental medical device within 30 days prior to trial entry
history of severe drug allergy, drug hypersensitivity or neuroleptic malignant syndrome
known clinically significant laboratory abnormalities
known clinically significant ECG abnormalities
significant physical illness that might interfere with the trial conduct
subject with mental retardation
known hypersensitivity to risperidone
subjects with phenylketonuria
subject with acute risk of suicide at study entry
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