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

This study has been terminated.
(This study was early terminated due to insufficient enrollment required for hypothesis testing.)
Sponsor:
Information provided by (Responsible Party):
Janssen Korea, Ltd., Korea
ClinicalTrials.gov Identifier:
NCT01592201
First received: February 10, 2012
Last updated: June 24, 2014
Last verified: June 2014
  Purpose

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 Intervention Phase
Schizophrenia
Drug: Paliperdidone ER
Drug: Aripiprazole, olanzapine and risperidone (Antipsychotics)
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Janssen Korea, Ltd., Korea:

Primary Outcome Measures:
  • Change From Baseline in the medication satisfaction questionnaire (MSQ) score at Week 8 [ Time Frame: Baseline and Week 8 ] [ Designated as safety issue: No ]
    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:
  • Positive and negative symptoms scale (PANSS) score [ Time Frame: Baseline to Week 12 ] [ Designated as safety issue: No ]
    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)

  • Drug Attitude Inventory (DAI)-10 Score [ Time Frame: Baseline to Week 12 ] [ Designated as safety issue: No ]
    DAI-10 is a 10-item scale developed to assess how the attitude of schizophrenia patients toward their medications may affect compliance (-10~+10)

  • Clinical Global Impression-Severity (CGI-S) Score [ Time Frame: Baseline to Week 12 ] [ Designated as safety issue: No ]
    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)

  • Personal and Social Performance Scale (PSP) [ Time Frame: Baseline to Week 12 ] [ Designated as safety issue: No ]
    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

  • Sleep Visual Analog Scale (Sleep VAS) [ Time Frame: Baseline to Week 12 ] [ Designated as safety issue: No ]
    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

  • Number of patients with adverse events [ Time Frame: Baseline to Week 12 ] [ Designated as safety issue: Yes ]
  • Number of patients with vital signs and physical examination [ Time Frame: Baseline to Week 12 ] [ Designated as safety issue: Yes ]
  • Number of patients with laboratory test (prolactin, blood glucose, glycosylated hemoglobin, cholesterol, triglyceride) [ Time Frame: Baseline to Week 12 ] [ Designated as safety issue: Yes ]

Enrollment: 13
Study Start Date: July 2012
Study Completion Date: June 2013
Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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

Ages Eligible for Study:   20 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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)
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01592201

Locations
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
Investigators
Study Director: Janssen Korea, Ltd., Korea Clinical Trial Janssen Korea, Ltd., Korea
  More Information

Additional Information:
No publications provided

Responsible Party: Janssen Korea, Ltd., Korea
ClinicalTrials.gov Identifier: NCT01592201     History of Changes
Other Study ID Numbers: CR100782, PAL-KOR-4019, R076477SCH4064
Study First Received: February 10, 2012
Last Updated: June 24, 2014
Health Authority: Korea: Food and Drug Administration (KFDA)
Republic of Korea: Food and Drug Administration

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

Additional relevant MeSH terms:
Schizophrenia
Mental Disorders
Schizophrenia and Disorders with Psychotic Features
9-hydroxy-risperidone
Antipsychotic Agents
Aripiprazole
Olanzapine
Risperidone
Antiemetics
Autonomic Agents
Central Nervous System Agents
Central Nervous System Depressants
Dopamine Agents
Dopamine Antagonists
Gastrointestinal Agents
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Neurotransmitter Uptake Inhibitors
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Psychotropic Drugs
Serotonin Agents
Serotonin Antagonists
Serotonin Uptake Inhibitors
Therapeutic Uses
Tranquilizing Agents

ClinicalTrials.gov processed this record on October 20, 2014