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

Schizophrenia Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01682161
• Other study ID #: CR100740
• Secondary ID: R092670SCH4010PA
• Status: Completed
• Phase: Phase 4
• First received: September 6, 2012
• Last updated: July 31, 2014
• Start date: January 2012
• Est. completion date: September 2013

Study information

• Verified date: July 2014
• Source: Janssen Korea, Ltd., Korea
• Contact: n/a
• Is FDA regulated: No
• Health authority: Republic of Korea: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 154
• Est. completion date: September 2013
• Est. primary completion date: September 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 65 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Schizophrenia

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Janssen Korea, Ltd., Korea

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline to Week 21 in scores of Medication Satisfaction Questionnaire (MSQ)	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.	Screening (Week -2), baseline (Week 0), Week 1, Week 5, Week 8, Week 9, Week 13, Week 17, and Week 21	No
Secondary	Change from baseline to Week 21 in scores of Treatment Satisfaction Questionnaire for Medication (TSQM)	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.	Screening, baseline, Week 1, Week 5, Week 8, Week 9, Week 13, Week 17, and Week 21	No
Secondary	Change from baseline to Week 21 in scores of Positive and Negative Syndrome Scale (PANSS)	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.	Baseline, Week 8, and Week 21	No
Secondary	Change from baseline to Week 21 in scores of Clinical Global Impression - Severity (CGI-S) scale	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.	Baseline, Week 1, Week 5, Week 8, Week 9, Week 13, Week 17, and Week 21	No
Secondary	Change from baseline to Week 21 in scores of Personal and Social Performance (PSP) scale	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.	Baseline, Week 8, and Week 21	No
Secondary	Score of Mediation Adherence Rating Scale (MARS)	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).	Baseline	No

External Links

•   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