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

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

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.

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.

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

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

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