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

NCT01682161 | Completed Phase 4

• 3 other identifiers: CR100740R092670SCH4010PALM-KOR-4001
• Study Type: interventional
• Target: 154
• Locations: 1 country
• Sites: 9

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.

Conditions

Schizophrenia

Keywords

Schizophrenia; Paliperidone Palmitate; Invega Sustenna; Antipsychotics; Atypical antipsychotics; Medication Satisfaction and Adherence

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (5)

• Change from baseline to Week 21 in scores of Treatment Satisfaction Questionnaire for Medication (TSQM)

  Screening, baseline, Week 1, Week 5, Week 8, Week 9, Week 13, Week 17, and Week 21

• Change from baseline to Week 21 in scores of Positive and Negative Syndrome Scale (PANSS)

  Baseline, Week 8, and Week 21

• Change from baseline to Week 21 in scores of Clinical Global Impression - Severity (CGI-S) scale

  Baseline, Week 1, Week 5, Week 8, Week 9, Week 13, Week 17, and Week 21

• Change from baseline to Week 21 in scores of Personal and Social Performance (PSP) scale

  Baseline, Week 8, and Week 21

• Score of Mediation Adherence Rating Scale (MARS)

  Baseline

Study Arms (2)

Group 1 (Immediate switch)

EXPERIMENTAL

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

Drug: Paliperidone palmitate

Group 2 (Delayed switch)

EXPERIMENTAL

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

Drug: Paliperidone palmitate

Interventions

Paliperidone palmitate 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.

Also known as: INVEGA SUSTENNA

Group 1 (Immediate switch); Group 2 (Delayed switch)

Eligibility Criteria

• Age: 20 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Janssen Korea, Ltd., Korea: lead

Study Sites (9)

Unknown Facility

Buchun, South Korea

Location

Unknown Facility

Cheonan, South Korea

Location

Unknown Facility

Chungcheongbuk-Do, South Korea

Location

Unknown Facility

Daegu, South Korea

Location

Unknown Facility

Goyang, South Korea

Location

Unknown Facility

Gyeonggi-do, South Korea

Location

Unknown Facility

Incheon, South Korea

Location

Unknown Facility

Seognam-Si, Kyungki-Do, South Korea

Location

Unknown Facility

Seoul, South Korea

Location

Related 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

MeSH Terms

Conditions

Schizophrenia

Interventions

Paliperidone Palmitate

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Isoxazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Pyrimidines

Study Officials

• Janssen Korea, Ltd., Korea Clinical Trial

  Janssen Korea, Ltd., Korea

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 6, 2012
• First Posted: September 10, 2012
• Study Start: January 1, 2012
• Primary Completion: September 1, 2013
• Study Completion: September 1, 2013
• Last Updated: August 1, 2014

Record last verified: 2014-07

Locations

KR (9)