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
Information source: Janssen Korea, Ltd., Korea
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Schizophrenia
Intervention: Paliperidone palmitate (Drug)
Phase: Phase 4
Status: Completed
Sponsored by: Janssen Korea, Ltd., Korea Official(s) and/or principal investigator(s): Janssen Korea, Ltd., Korea Clinical Trial, Study Director, Affiliation: Janssen Korea, Ltd., Korea
Summary
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.
Clinical Details
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
Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Change from baseline to Week 21 in scores of Medication Satisfaction Questionnaire (MSQ)
Secondary outcome: Change from baseline to Week 21 in scores of Treatment Satisfaction Questionnaire for Medication (TSQM)Change from baseline to Week 21 in scores of Positive and Negative Syndrome Scale (PANSS) Change from baseline to Week 21 in scores of Clinical Global Impression - Severity (CGI-S) scale Change from baseline to Week 21 in scores of Personal and Social Performance (PSP) scale Score of Mediation Adherence Rating Scale (MARS)
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
Minimum age: 20 Years.
Maximum age: 65 Years.
Gender(s): Both.
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
Locations and Contacts
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
Additional Information
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
Starting date: January 2012
Last updated: July 31, 2014
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