A blinded-initiation study of medication satisfaction in subjects with schizophrenia treated with paliperidone ER after suboptimal response to oral risperidone.

• Register: EUCTR
• Last refreshed on: 19 March 2012
• Main ID: EUCTR2007-004482-18-CZ
• Date of registration: 05/12/2007
• Prospective Registration: Yes
• Primary sponsor: Ortho-McNeil Janssen Scientific Affairs, LLC
• Public title: A blinded-initiation study of medication satisfaction in subjects with schizophrenia treated with paliperidone ER after suboptimal response to oral risperidone.
• Scientific title: A blinded-initiation study of medication satisfaction in subjects with schizophrenia treated with paliperidone ER after suboptimal response to oral risperidone.
• Date of first enrolment: 03/01/2008
• Target sample size: 150
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2007-004482-18
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes Randomised: yes Open: no Single blind: no Double blind: yes Parallel group: yes Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: yes Placebo: no Other: no

Countries of recruitment

Czech Republic

Key inclusion & exclusion criteria

Inclusion criteria:
1. Male or female at least 18 years of age
2. Must be able to understand, in the opinion of the investigator, the informed consent form approved by the Independent Ethics Committee/Institutional Review Board (IEC/IRB). All subjects must sign the study informed consent document indicating that they understand the purpose of the study and the procedures required for the study and are willing to participate in the study. If a subject has an appointed legal representative, both the representative and the subject will sign the consent form. Subjects who are unable to provide their own consent are not eligible to enroll in the study. In addition, reasonable efforts should be made to provide information about the study to all subjects’ designated contact person.
3. Female subjects must be postmenopausal for at least 1 year, surgically sterile, abstinent, or, if sexually active, be practicing an effective method of birth control (e.g., prescription oral contraceptives, contraceptive injections, intrauterine device, double-barrier method, contraceptive patch, male partner sterilization) before entry and throughout the study; and a negative urine pregnancy test at screening.
4. Male subjects must be abstinent, surgically sterile, or, if sexually active, be practicing an effective method of birth control (e.g. double barrier method, or, their female partner must be surgically sterile, or using prescription oral contraceptives, contraceptive injections, contraceptive patch or have an intrauterine device) before entry and throughout the study.
5. Be diagnosed with schizophrenia according to DSM IV (295.30 paranoid type, 295.10 disorganized type, 295.90 undifferentiated type, or residual type 295.60)
6. Have scores of at least 4 ("Moderate") on at least 3 of the following symptom factors of the PANSS at the screening and baseline visits:
• G4 Tension
• G9 Unusual thought content
• P1 Delusions
• P3 Hallucinatory behavior
• P4 Excitement
• P5 Grandiosity
• P6 Suspiciousness/persecution
7. Report dissatisfaction with current medication as measured by a TSQM Item #14 score of 1 to 3 ("Extremely Dissatisfied", "Very Dissatisfied", or "Dissatisfied") at the screening and baseline visits
8. Have an aspect of disease management, which, in the investigator's opinion, could potentially benefit from a change in antipsychotic medication
9. Receive oral risperidone 4 mg or 6 mg for at least 4 weeks immediately
before randomization.
10. Willing and able, in the investigator's opinion, to remain compliant and adhere to the prohibitions and restrictions specified in this protocol
11. Be able, in the opinion of the investigator, to comply with self-administration of medication or have consistent help/support available to supervise medication administration
12. Outpatients, who in the opinion of the investigator, are likely to remain
outpatient during the course of the study (subjects who are chronically
hospitalized for purely social reasons, but otherwise meet entry criteria, may be considered for inclusion on a case-by-case bases after review by
the sponsor).
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion criteria:
General:

1. Inability to swallow study drug whole with the aid of water (subjects may not chew, divide, dissolve, or crush the study drug, as this may affect the release profile)
2. Have received an investigational drug, used an investigational medical device, or participated in a clinical study that altered their medication within 6 months before the first administration of study drug, or have participated in more than 2 investigational drug studies within the past 12 months
3. Women who are pregnant (as confirmed by urine pregnancy test performed at baseline), planning to become pregnant, or breast-feeding
4. Any employee or family member of the Investigator, Johnson & Johnson, or the institution that has direct involvement with the trial or other trials under the direction of the Investigator or their staff members

Psychiatric History:

5. Clinical Global Impressions-Severity (CGI-S) less than 4 at the screening visit
6. DSM IV criteria for any other Axis I diagnosis with the exception of nicotine dependence (use of tobacco or products containing tobacco is permitted)
7. DSM IV criteria for substance or alcohol dependence within the past 6 months
8. Use of cocaine or heroin within 3 months before the first administration of study drug
9. Positive urine drug screen for cocaine, opiates, or amphetamines at the screening visit
10. History of neuroleptic malignant syndrome or tardive dyskinesia/dystonia
11. History of violence or, as deemed by the investigator, at imminent risk for harming others or damaging property
12. History of attempted suicide within 12 months before study entry or, as deemed by the investigator, at imminent risk of suicide or self harm

Treatment History:

13. Hospitalized for psychotic symptoms within 4 weeks before first administration of study drug
14. Hospitalized for psychotic symptoms or relapse more than 2 times within the past 6 months
15. Established treatment-refractory schizophrenia as evidenced by any of the following:
A. those who have had treatment failures or no clinical response despite adequate doses and duration of treatment with 2 antipsychotic drugs from different classes (failure to tolerate a medication does not count toward this definition), or
B. previous treatment with clozapine for established treatment-refractory schizophrenia within the past 5 years, or
C. hospitalization for psychotic symptoms for 4 or more times in the last 12 months, except for purely social reasons (e.g., food, housing, shelter, or respite care)
16. History of hypersensitivity to paliperidone or risperidone
17. Treatment history of failure to respond to risperidone or paliperidone
18. History of any of the following disallowed therapies:
A. treatment with any antipsychotic in addition to treatment with risperidone within 30 days before the baseline visit; or
B. treatment with paliperidone within 30 days before the baseline visit; or
C. treatment with depot antipsychotics, including long-acting injectable risperidone and paliperidone palmitate, within 3 months (90 days) of the screening visit; or
D. any treatment with clozapine within the previous 60 days; or
E. treatment with carbamazepine within 60 days before the baseline visit

Medical History:

19. History of significant neurological or medical disease
20. History of seizure disorder and/or head injury
21. Evidence of clinically significant or unstable cardiovascular, gastrointestinal, neurological, endocrine, metabo

Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Schizophrenia
MedDRA version: 9.1 Level: LLT Classification code 10039626 Term: Schizophrenia

Intervention(s)

Trade Name: INVEGA
Pharmaceutical Form: Tablet
INN or Proposed INN: Paliperidone
CAS Number: 144598-75-4
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 3-

Trade Name: INVEGA
Pharmaceutical Form: Tablet
INN or Proposed INN: Paliperidone
CAS Number: 144598-75-4
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 6-
Pharmaceutical form of the placebo: Capsule*
Route of administration of the placebo: Oral use

Trade Name: Risperdal
Pharmaceutical Form: Tablet
INN or Proposed INN: Risperidone
CAS Number: 106266-06-2
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 2-
Pharmaceutical form of the placebo: Capsule*
Route of administration of the placebo: Oral use

Primary Outcome(s)

Secondary Objective: The secondary objectives are to explore efficacy and safety outcomes in subjects treated with paliperidone ER for up to 6 weeks

Main Objective: The primary objective of this study is to assess the observed change in the
Medication Satisfaction Questionnaire (MSQ) score, from baseline to the
Week 6 endpoint, when paliperidone ER (6 mg to 12 mg) is administered for
at least 4 weeks to subjects with schizophrenia who are suboptimally
responsive to oral risperidone 4 mg or 6 mg.

Primary end point(s): The primary outcome measurement is the subject assessed Medication Satisfaction Questionnaire (MSQ) score.

Secondary ID(s)

R076477-SCH-4013