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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01592201
Recruitment Status : Terminated (This study was early terminated due to insufficient enrollment required for hypothesis testing.)
First Posted : May 7, 2012
Last Update Posted : June 25, 2014
Information provided by (Responsible Party):
Janssen Korea, Ltd., Korea

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)

Condition or disease Intervention/treatment Phase
Schizophrenia Drug: Paliperdidone ER Drug: Aripiprazole, olanzapine and risperidone (Antipsychotics) Phase 4

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 13 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : July 2012
Actual Primary Completion Date : June 2013
Actual Study Completion Date : June 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Schizophrenia
U.S. FDA Resources

Arm Intervention/treatment
Experimental: Paliperidone ER
Immediate initiation of Paliperidone ER for a total of 12 weeks
Drug: Paliperdidone ER
Form = osmotic release oral system, route = oral
Experimental: Antipsychotics and paliperidone ER
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.
Drug: Paliperdidone ER
Form = osmotic release oral system, route = oral
Drug: Aripiprazole, olanzapine and risperidone (Antipsychotics)
Form = tablet, route = oral

Primary Outcome Measures :
  1. Change From Baseline in the medication satisfaction questionnaire (MSQ) score at Week 8 [ Time Frame: Baseline and Week 8 ]
    A single-item, global, patient-completed instrument that is read aloud to patients by clinicians designed to assess treatment satisfaction among patients with schizophrenia. It consists of one question: "Overall, how satisfied are you with your current antipsychotic medication(s)?" with responses assessed on a 7-point scale rated as follows: 1 = extremely dissatisfied, 2=very dissatisfied, 3=somewhat dissatisfied, 4=neither satisfied nor dissatisfied, 5=somewhat satisfied, 6 = very satisfied, 7 = extremely satisfied

Secondary Outcome Measures :
  1. Positive and negative symptoms scale (PANSS) score [ Time Frame: Baseline to Week 12 ]
    The PANSS provides a total score (sum of the scores of all 30 items) and scores for 3 subscales, the positive subscale (7 items), the negative subscale (7 items), and the general psychopathology subscale (16 items), each rated on a scale of 1 (absent) to 7 (extreme). It's designed to capture symptoms of schizophrenia. (Gold standard)

  2. Drug Attitude Inventory (DAI)-10 Score [ Time Frame: Baseline to Week 12 ]
    DAI-10 is a 10-item scale developed to assess how the attitude of schizophrenia patients toward their medications may affect compliance (-10~+10)

  3. Clinical Global Impression-Severity (CGI-S) Score [ Time Frame: Baseline to Week 12 ]
    The CGI-S rating scale is used to rate the severity of a patient's psychotic condition on a 7-point scale ranging from 1 (not ill) to 7 (extremely severe)

  4. Personal and Social Performance Scale (PSP) [ Time Frame: Baseline to Week 12 ]
    This scale assesses the degree of dysfunction a patient exhibits within 4 domains of behavior: socially useful activities, personal and social relationships, self-care, and disturbing and aggressive behavior. The score ranges from 1 to 100, divided into 10 equal intervals to rate the degree of difficulty (i, absent to vi, very severe) in each of the 4 domains. Based on the four domains there will be one total score. Patient's with a score of 71 to 100 have a mild degree of difficulty; from 31 to 70, varying degrees of disability; ≤ 30, functioning so poorly as to require intensive supervision

  5. Sleep Visual Analog Scale (Sleep VAS) [ Time Frame: Baseline to Week 12 ]
    This self-administered scale rates quality of sleep and daytime drowsiness. Patient's will indicate on an 11- point scale (from 0 to 10) how well they have slept in the previous 7 days ("very badly" to "very well") and how often they have felt drowsy within the previous 7 days ("not at all" to "all the time"). On the sleep evaluation scale, score '0' corresponds to 'very badly' and score '10' to 'very well'. On the daytime drowsiness scale, score '0' corresponds to 'not at all' and score '10' to 'all the time

  6. Number of patients with adverse events [ Time Frame: Baseline to Week 12 ]
  7. Number of patients with vital signs and physical examination [ Time Frame: Baseline to Week 12 ]
  8. Number of patients with laboratory test (prolactin, blood glucose, glycosylated hemoglobin, cholesterol, triglyceride) [ Time Frame: Baseline to Week 12 ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:   20 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01592201

Korea, Republic of
Busan, Korea, Republic of
Cheonan City, Korea, Republic of
Chuncheon-Si, Korea, Republic of
Chungju-Si, Korea, Republic of
Dae-Gu, Korea, Republic of
Daejeon, Korea, Republic of
Goyang-Si, Korea, Republic of
Gyeonggi-Do, Korea, Republic of
Seoul, Korea, Republic of
Sponsors and Collaborators
Janssen Korea, Ltd., Korea
Study Director: Janssen Korea, Ltd., Korea Clinical Trial Janssen Korea, Ltd., Korea

Additional Information:
Responsible Party: Janssen Korea, Ltd., Korea Identifier: NCT01592201     History of Changes
Other Study ID Numbers: CR100782
PAL-KOR-4019 ( Other Identifier: Janssen Korea, Ltd., Korea )
R076477SCH4064 ( Other Identifier: Janssen Korea, Ltd., Korea )
First Posted: May 7, 2012    Key Record Dates
Last Update Posted: June 25, 2014
Last Verified: June 2014

Keywords provided by Janssen Korea, Ltd., Korea:
Paliperidone ER
Mental disorder
Comparative study

Additional relevant MeSH terms:
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders
Paliperidone Palmitate
Antipsychotic Agents
Serotonin Antagonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs
Dopamine Antagonists
Dopamine Agents
Autonomic Agents
Peripheral Nervous System Agents
Gastrointestinal Agents
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Serotonin 5-HT2 Receptor Antagonists
Dopamine D2 Receptor Antagonists