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

NCT ID: NCT01682161

Last Updated: 2014-08-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 154 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-01-31
• Study Completion Date: 2013-09-30

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.

Conditions

Schizophrenia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Group 1 (Immediate switch)

Paliperidone palmitate will be administered immediately after randomization and will be continued throughout the treatment phase.

Group Type: EXPERIMENTAL

Paliperidone palmitate

Intervention Type: DRUG

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.

Group 2 (Delayed switch)

Current oral antipsychotics will be continued until Week 8, and later on paliperidone palmitate will be administered.

Group Type: EXPERIMENTAL

Paliperidone palmitate

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: DRUG

Other Intervention Names

INVEGA SUSTENNA

Eligibility Criteria

Inclusion Criteria

• 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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Janssen Korea, Ltd., Korea

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Janssen Korea, Ltd., Korea Clinical Trial

Role: STUDY_DIRECTOR

Janssen Korea, Ltd., Korea

Locations

Buchun, , South Korea

Cheonan, , South Korea

Chungcheongbuk-Do, , South Korea

Daegu, , South Korea

Goyang, , South Korea

Gyeonggi-do, , South Korea

Incheon, , South Korea

Seognam-Si, Kyungki-Do, , South Korea

Seoul, , South Korea

Countries

South Korea

Related Links

http://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_JNJ_6051&studyid=3405&filename=CR100740_CSR.pdf

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

Other Identifiers

R092670SCH4010

Identifier Type: OTHER

Identifier Source: secondary_id

PALM-KOR-4001

Identifier Type: OTHER

Identifier Source: secondary_id

CR100740

Identifier Type: -

Identifier Source: org_study_id