A Comparative Study to Evaluate the Evolution of Medication Satisfaction and Adherence in Patients Unsatisfied With Current Oral Atypical Antipsychotics by Switching Medication to Paliperidone Palmitate

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Janssen Korea, Ltd., Korea
ClinicalTrials.gov Identifier:
NCT01682161
First received: September 6, 2012
Last updated: July 31, 2014
Last verified: July 2014
  Purpose

The purpose of this study is to evaluate the change of medication satisfaction measured by Medication Satisfaction Questionnaire (MSQ) from baseline to endpoint for patients who are switched into paliperidone palmitate, either immediately or in a delayed mode.


Condition Intervention Phase
Schizophrenia
Drug: Paliperidone palmitate
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, Comparative Study of Immediate or Delayed Switch to Paliperidone Palmitate in Patients Unsatisfied With Current Oral Atypical Antipsychotics to Evaluate the Evolution of Medication Satisfaction and Adherence

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Change from baseline to Week 21 in scores of Medication Satisfaction Questionnaire (MSQ) [ Time Frame: Screening (Week -2), baseline (Week 0), Week 1, Week 5, Week 8, Week 9, Week 13, Week 17, and Week 21 ] [ Designated as safety issue: No ]
    MSQ is designed to assess treatment satisfaction among patients with schizophrenia. The responses will be assessed on a 7-point Likert-type scale rated as follows: 1=extremely dissatisfied, 2=very dissatisfied, 3=somewhat dissatisfied, 4=neither satisfied nor dissatisfied, 5=somewhat satisfied, 6=very satisfied, and 7=extremely satisfied.


Secondary Outcome Measures:
  • Change from baseline to Week 21 in scores of Treatment Satisfaction Questionnaire for Medication (TSQM) [ Time Frame: Screening, baseline, Week 1, Week 5, Week 8, Week 9, Week 13, Week 17, and Week 21 ] [ Designated as safety issue: No ]
    The TSQM is a 14-item subject assessed evaluation of treatment medication using a 7-point Likert-type 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.

  • Change from baseline to Week 21 in scores of Positive and Negative Syndrome Scale (PANSS) [ Time Frame: Baseline, Week 8, and Week 21 ] [ Designated as safety issue: No ]
    The PANSS is a medical scale used for measuring symptom severity of patients with schizophrenia. The neuropsychiatric symptoms of schizophrenia will be assessed using the 30-item PANSS scale. Each item is rated as follows: 1=absent, 2=Minimal, 3=Mild, 4=Moderate, 5=Moderate Severe, 6=Severe, and 7=Extreme.

  • Change from baseline to Week 21 in scores of Clinical Global Impression - Severity (CGI-S) scale [ Time Frame: Baseline, Week 1, Week 5, Week 8, Week 9, Week 13, Week 17, and Week 21 ] [ 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. It is rated as follows: 1=Normal, not at all ill, 2=Borderline mentally ill, 3=Mildly ill, 4=Moderately ill, 5=Markedly ill, 6=Severely ill, and 7=Among the most extremely ill.

  • Change from baseline to Week 21 in scores of Personal and Social Performance (PSP) scale [ Time Frame: Baseline, Week 8, and Week 21 ] [ Designated as safety issue: No ]
    The PSP is a clinician rated instrument providing an overall rating of personal and social functioning in patients with schizophrenia on a scale of 1-100. The scale defines a continuum from grossly impaired functioning, in which total lack of autonomy in basic functioning and survival risk is evident, to excellent functioning. Four domains of functioning are considered in the rating: 1) socially useful activities, including work and study, 2) personal and social relationships, 3) self-care, and 4) disturbing and aggressive behavior.

  • Score of Mediation Adherence Rating Scale (MARS) [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    The MARS is a 10-items self-rating scale to measure the adherence of the drug medication for psychosis. Each item is answered "yes/no" and the total score ranges from 0 points (Low medication adherence) to 10 points (High medication adherence).


Enrollment: 154
Study Start Date: January 2012
Study Completion Date: September 2013
Primary Completion Date: September 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Group 1 (Immediate switch)
Paliperidone palmitate will be administered immediately after randomization and will be continued throughout the treatment phase.
Drug: Paliperidone palmitate
Paliperidone palmitate will be administrated in accordance with each product's information. Recommended initial loading doses are 150 mg equivalent on Day 1 and 100 mg equivalent on Day 8, followed by subsequent once-monthly administration with 75 mg equivalent or flexible dose between 25 mg and 150 mg equivalent.
Other Name: INVEGA SUSTENNA
Experimental: Group 2 (Delayed switch)
Current oral antipsychotics will be continued until Week 8, and later on paliperidone palmitate will be administered.
Drug: Paliperidone palmitate
Paliperidone palmitate will be administrated in accordance with each product's information. Recommended initial loading doses are 150 mg equivalent on Day 1 and 100 mg equivalent on Day 8, followed by subsequent once-monthly administration with 75 mg equivalent or flexible dose between 25 mg and 150 mg equivalent.
Other Name: INVEGA SUSTENNA

Detailed Description:

This is a prospective (patients are first identified and then followed forward as time passes), multicenter (study conducted at multiple sites), randomized (the study medication is assigned by chance), comparative and open-labeled (all people know the identity of the intervention) study.

The study mainly consists of 3 phases including, the screening phase (14 days before administration of study medication), treatment phase, and the follow-up phase (28 days after the last dose of the study medication). In the treatment phase, patients will be randomly assigned equally in 2 groups (Group 1 and Group 2), on the basis of known and unknown characteristics. Group 1 (immediate switch group): Patients will be administered with paliperidone palmitate immediately after randomization and will continue throughout the treatment phase. Group 2 (delayed switch group): Patients will remain on current oral antipsychotics until Week 8, and later on will be completely switched to paliperidone palmitate. However, during the first 8 weeks if the symptoms or satisfaction with MSQ further deteriorates for Group 2, they may be switched into paliperidone palmitate earlier.

Safety evaluations will include evaluation of adverse events, clinical laboratory tests, electrocardiogram, vital signs, and physical examination and these will be monitored throughout the study.

The total duration of the study will be approximately 148 days.

  Eligibility

Ages Eligible for Study:   20 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:- Meet diagnostic criteria for schizophrenia according to Diagnostic and Statistical Manual of Mental Disorders Version IV

  • Dissatisfied with current medication (Medication Satisfaction Questionnaire score of less than or equal to 4) or by clinician's judgment and who may benefit from switching medication
  • Have received an oral antipsychotic for at least 4 weeks before randomization
  • Agrees to protocol-defined use of effective contraception

Exclusion Criteria:

History of neuroleptic malignant syndrome

  • Presence of congenital prolongation of the QT interval - History of treatment with depot antipsychotics, including long-acting injectable risperidone and paliperidone palmitate, within 90 days of the screening visit; or any treatment with clozapine within the previous 60 days
  • Any relevant medical history or current presence of systemic disease
  • Significant risk of suicidal, homicidal or violent ideation or behavior as clinically assessed by the investigator
  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: NCT01682161

Locations
Korea, Republic of
Buchun, Korea, Republic of
Cheonan City, Korea, Republic of
Chungcheongbuk-Do, Korea, Republic of
Daegu, Korea, Republic of
Goyang, Korea, Republic of
Gyeonggi-Do, Korea, Republic of
Incheon, Korea, Republic of
Seognam-Si, Kyungki-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: NCT01682161     History of Changes
Other Study ID Numbers: CR100740, R092670SCH4010, PALM-KOR-4001
Study First Received: September 6, 2012
Last Updated: July 31, 2014
Health Authority: Republic of Korea: Food and Drug Administration

Keywords provided by Janssen Korea, Ltd., Korea:
Schizophrenia
Paliperidone Palmitate
Invega Sustenna
Antipsychotics
Atypical antipsychotics
Medication Satisfaction and Adherence

Additional relevant MeSH terms:
Schizophrenia
Schizophrenia and Disorders with Psychotic Features
Mental Disorders
Antipsychotic Agents
9-hydroxy-risperidone
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Psychotropic Drugs

ClinicalTrials.gov processed this record on September 16, 2014