Clinical trial NCT01592201: 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
Official title: An Open-label, Prospective, Randomized and 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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Schizophrenia
Keywords: Schizophrenia
Paliperidone ER
Antipsychotics
Mental disorder
Comparative study
Lead sponsor: Janssen Korea, Ltd., Korea
Sponsor class: INDUSTRY
First posted: 2012-05-07
Enrollment: 13
Sex: ALL
Minimum age (years): 20
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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)

Detailed 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.

Eligibility criteria: 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)

Primary outcomes:
measure: Change From Baseline in the medication satisfaction questionnaire (MSQ) score at Week 8
timeFrame: Baseline and Week 8
Secondary outcomes:
measure: Positive and negative symptoms scale (PANSS) score
timeFrame: Baseline to Week 12
measure: Drug Attitude Inventory (DAI)-10 Score
timeFrame: Baseline to Week 12
measure: Clinical Global Impression-Severity (CGI-S) Score
timeFrame: Baseline to Week 12
measure: Personal and Social Performance Scale (PSP)
timeFrame: Baseline to Week 12
measure: Sleep Visual Analog Scale (Sleep VAS)
timeFrame: Baseline to Week 12
measure: Number of patients with adverse events
timeFrame: Baseline to Week 12
measure: Number of patients with vital signs and physical examination
timeFrame: Baseline to Week 12
measure: Number of patients with laboratory test (prolactin, blood glucose, glycosylated hemoglobin, cholesterol, triglyceride)
timeFrame: Baseline to Week 12
Other outcomes:
Locations:
city: Busan
country: Korea, Republic of
city: Cheonan City
country: Korea, Republic of
city: Chuncheon-Si
country: Korea, Republic of
city: Chungju-Si
country: Korea, Republic of
city: Dae-Gu
country: Korea, Republic of
city: Daejeon
country: Korea, Republic of
city: Goyang-Si
country: Korea, Republic of
city: Gyeonggi-Do
country: Korea, Republic of
city: Seoul
country: Korea, Republic of
Study officials:
affiliation: Janssen Korea, Ltd., Korea
name: Janssen Korea, Ltd., Korea Clinical Trial
role: STUDY_DIRECTOR
References: