Clinical trial NCT01682161: 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
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Schizophrenia
Keywords: Schizophrenia
Paliperidone Palmitate
Invega Sustenna
Antipsychotics
Atypical antipsychotics
Medication Satisfaction and Adherence
Lead sponsor: Janssen Korea, Ltd., Korea
Sponsor class: INDUSTRY
First posted: 2012-09-10
Enrollment: 154
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 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.

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 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

Primary outcomes:
measure: Change from baseline to Week 21 in scores of Medication Satisfaction Questionnaire (MSQ)
timeFrame: Screening (Week -2), baseline (Week 0), Week 1, Week 5, Week 8, Week 9, Week 13, Week 17, and Week 21
Secondary outcomes:
measure: Change from baseline to Week 21 in scores of Treatment Satisfaction Questionnaire for Medication (TSQM)
timeFrame: Screening, baseline, Week 1, Week 5, Week 8, Week 9, Week 13, Week 17, and Week 21
measure: Change from baseline to Week 21 in scores of Positive and Negative Syndrome Scale (PANSS)
timeFrame: Baseline, Week 8, and Week 21
measure: Change from baseline to Week 21 in scores of Clinical Global Impression - Severity (CGI-S) scale
timeFrame: Baseline, Week 1, Week 5, Week 8, Week 9, Week 13, Week 17, and Week 21
measure: Change from baseline to Week 21 in scores of Personal and Social Performance (PSP) scale
timeFrame: Baseline, Week 8, and Week 21
measure: Score of Mediation Adherence Rating Scale (MARS)
timeFrame: Baseline
Other outcomes:
Locations:
city: Buchun
country: Korea, Republic of
city: Cheonan City
country: Korea, Republic of
city: Chungcheongbuk-Do
country: Korea, Republic of
city: Daegu
country: Korea, Republic of
city: Goyang
country: Korea, Republic of
city: Gyeonggi-Do
country: Korea, Republic of
city: Incheon
country: Korea, Republic of
city: Seognam-Si, Kyungki-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: