Clinical trial NCT01726335: Switching From Oral Antipsychotics to Long-Acting Risperidone in Participants With Schizophrenia
Official title: An Open-Label Study of Oral Antipsychotics Replacement by Prolonged Release Risperidone (Risperdal Consta) in Schizophrenic Subjects With Bad Adhesion to the Treatment
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Schizophrenia
Keywords: Schizophrenia
Risperidone
Risperdal consta
Lead sponsor: Janssen-Cilag Ltd.
Sponsor class: INDUSTRY
First posted: 2012-11-14
Enrollment: 53
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate efficacy, safety and tolerance of long-acting risperidone when switching from oral antipsychotics in participants with schizophrenia (psychiatric disorder with symptoms of emotional instability, detachment from reality, often with delusions and hallucinations, and withdrawal into the self).

Detailed description: This is an open-label (all people know the identity of the intervention), multi-centric (conducted in more than one center) and non-comparative study of long-acting risperidone in participants with schizophrenia who have a previous history (in the last 12 months) of bad adherence to the oral antipsychotic treatment of first or second generation. The duration of this study will be 24 weeks and will include following visits: Screening, Baseline, Week 2, 4, 8, 12, 16, 20, 24, 38 and 50 (End visit or early withdrawal). All the eligible participants (after risperidone intolerance test during screening) will receive a dose of 25 milligram risperidone every two weeks by intramuscular injection (injection of a substance into a muscle). Efficacy and safety of the participants will primarily be evaluated by Positive and Negative Syndromes Scale and Extrapyramidal Symptom Rating Scale, respectively. Participants' safety will be monitored throughout the study.

Eligibility criteria: Inclusion Criteria:

* Have schizophrenia diagnosis by Diagnostic and Statistical Manual of Mental Disorders, fourth edition (DSM-IV)
* Be on treatment with oral antipsychotic of first or second generation, for a minimum time of 12 months
* Previous history of bad adhesion to oral antipsychotic treatment in the last 12 months
* Total Positive and Negative Syndrome Scale score less than or equal to 90, the conceptual disorganization, hallucinatory behavior, suspicion and not usual content of thought must be less than or equal to 4
* Be not pregnant as showed on negative pregnancy serum test

Exclusion Criteria:

* Contraindication or known hypersensitivity to risperidone
* Previous history of unsatisfactory response to risperidone
* Previous history of refractivity to the other second generation antipsychotics
* Use of antipsychotic of intramuscular deposit in the last 12 months
* Other mental disturbances of DSM-IV axis

Primary outcomes:
measure: Positive and Negative Syndromes Scale (PANSS) Total Score at Week 2
timeFrame: Week 2
measure: Positive and Negative Syndromes Scale (PANSS) Total Score at Week 4
timeFrame: Week 4
measure: Positive and Negative Syndromes Scale (PANSS) Total Score at Week 8
timeFrame: Week 8
measure: Positive and Negative Syndromes Scale (PANSS) Total Score at Week 16
timeFrame: Week 16
measure: Positive and Negative Syndromes Scale (PANSS) Total Score at Week 24
timeFrame: Week 24
measure: Positive and Negative Syndromes Scale (PANSS) Total Score at Week 38
timeFrame: Week 38
measure: Positive and Negative Syndromes Scale (PANSS) Total Score at Week 50
timeFrame: Week 50
Secondary outcomes:
measure: Clinical Global Impressions (CGI) - Disease Severity Score
timeFrame: Baseline and Week 2, 4, 8, 16, 24, 38 and 50
measure: Extrapyramidal Symptoms Rating Scale (ESRS) Total Score
timeFrame: Baseline and Week 2, 4, 8, 16, 24 and 50
measure: Drug Attitude Inventory (DAI-10)
timeFrame: Screening, and Week 8, 24 and 50
measure: Short Form-36 (SF-36) - Quality of Life
timeFrame: Baseline and Week 50
measure: Personal and Social Performance (PSP) Scale Score
timeFrame: Screening, and Week 8, 16, 24, 38 and 50
measure: Global Assessment of Functioning (GAF) Scale Score
timeFrame: Screening, and Week 8, 16, 24, 38 and 50
Other outcomes:
Locations:
city: Curitiba
country: Brazil
city: Porto Alegre
country: Brazil
city: Rio De Janeiro
country: Brazil
city: Salvador
country: Brazil
city: Sao Paulo
country: Brazil
Study officials:
affiliation: Janssen-Cilag Ltd.
name: Janssen-Cilag Ltd. Clinical trial
role: STUDY_DIRECTOR
References: