A Comparative Study of Patient Satisfaction Between Continued Administration of Previous Antipsychotics Versus Switched Administration to Paliperidone ER in Non-satisfied Patients With Previous Antipsychotic Drug

Janssen (J&J Innovative Medicine)

Status and phase: Terminated; Phase 4

Conditions: Schizophrenia

Treatments: Drug: Paliperdidone ER; Drug: Aripiprazole, olanzapine and risperidone (Antipsychotics)

Study type: Interventional

Funder types: Industry

Identifiers

NCT01592201

CR100782

R076477SCH4064 (Other Identifier)

PAL-KOR-4019 (Other Identifier)

Details and patient eligibility

About

The purpose of this study is to compare the patient satisfaction between continued administration of previous antipsychotics versus switched administration to paliperidone ER in non-satisfied patients with previous (paliperidone)

Full description

This is a randomized (patients are assigned to intervention by chance), prospective, open-label (all people involved know the identity of the assigned drug), switch study designed to evaluate patient-assessed medication satisfaction after 12 weeks of treatment in patients with schizophrenia. The total duration of this study is 12 weeks. Outpatients who treated atypical antipsychotics and report dissatisfaction (Medication Satisfaction Questionnaire [MSQ] <4) with their current treatment response are eligible to participate in the study. Patients will be randomized into two groups, 1) Patients randomized to an immediate initiation of paliperidone ER for a total 12 weeks 2) Patients randomized to a delayed initiation will continue their previous atypical antipsychotics for 8 weeks and then be initiated on paliperidone ER at Day 56 for 4 weeks. During the study treatment optimization will be done by dose adjustment (dose increase or decrease) and by adding psychotropic agents except the antipsychotics.

Enrollment: 13 patients

Sex: All

Ages: 20 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Must be diagnosed with schizophrenia according to the Diagnostic and Statistical Manual of Mental Disorders (DSM-IV) criteria
• Have taken atypical antipsychotics (aripiprazole, olanzapine, risperidone) at least 6 weeks prior to start of study.
• Have Medication Satisfaction Questionnaire (MSQ) score of ≤3
• Competent patients who manage to answer the questionnaires

Exclusion criteria

• Have had a history or current symptoms of tardive dyskinesia or neuroleptic malignant syndrome
• Have had relevant history of or current presence of any significant or unstable cardiovascular, respiratory, neurological (including seizures or significant cerebrovascular), renal, hepatic, hematologic, endocrine, immunologic, morbid obesity (BMI≥40), or other systemic disease
• Had received two or more different kind of antipsychotics.
• Had a history of taking paliperidone extended release (ER).
• Allergy or hypersensitivity to risperidone or paliperidone ER.
• Have been on clozapine or long-acting injectable antipsychotic medication during the last 3 months.
• Have had Medication Satisfaction Questionnaire (MSQ) score>3
• Have been hospitalized for longer than 8 continuous weeks during the past 6 months
• Had history of any severe preexisting gastrointestinal narrowing (pathologic or iatrogenic) or inability to swallow the oral tolerability medication whole with the aid of water for patients requiring oral tolerability testing
• Current substance dependence (DSM-IV) or past history of dependence (more than 6 months)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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13 participants in 2 patient groups

Paliperidone ER

Experimental group

Description:

Immediate initiation of Paliperidone ER for a total of 12 weeks

Treatment:

Drug: Paliperdidone ER

Antipsychotics and paliperidone ER

Experimental group

Description:

Delayed initiation included previous atypical antipsychotics for 8 weeks and then be initiated on paliperidone ER at Day 56 for 4 weeks. The atypical antipsychotics includes aripiprazole, olanzapine and risperidone. These antipsychotics belongs to the class of second generation bipolar atypical antipsychotics.

Treatment:

Drug: Paliperdidone ER

Drug: Aripiprazole, olanzapine and risperidone (Antipsychotics)