Clinical trial NCT01142596: Long-term Extension Trial of Asenapine in Subjects With Schizophrenia (Study P06125)
Official title: Long-term Extension Trial of Asenapine in Subjects With Schizophrenia (Phase 3 ; Protocol No. P06125)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Schizophrenia
Lead sponsor: Organon and Co
Sponsor class: INDUSTRY
Collaborators: name: Meiji Seika Pharma Co., Ltd.
First posted: 2010-06-11
Enrollment: 201
Sex: ALL
Minimum age (years): 20
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a multi-site, randomized fixed-flexible dose long-term study of asenapine in participants with schizophrenia. The first six weeks of the study will be double-blind and the remainder of the study will be open label. Participants in this study consist of participants who have completed the preceding short-term study (P06124 \[NCT01098110\]), who meet the inclusion criteria and wish to continue receiving study drug, and whom the investigators have deemed eligible for study participation. Participants who were on placebo twice daily (BID) in core trial P06124 will get placebo for the first 2 weeks then 5 mg asenapine BID for the next 4 weeks of double blind treatment, and will be re-randomized after week 6 to asenapine 5 mg BID or asenapine 10 mg BID. Participants who were on asenapine 5 mg BID in core trial P06124 will be re-randomized after Week 6 to asenapine 5 mg BID or asenapine 10 mg BID. Participants who were on asenapine 10 mg BID in core trial P06124 will be re-randomized after Week 6 to asenapine 5 mg BID or asenapine 10 mg BID. After re-randomization, drug will be administered open-label for 46 weeks. During this period dose is flexible can be adjusted using dose options of 5 and 10 mg BID for efficacy and tolerability.


Eligibility criteria: Inclusion Criteria:

* Participant has completed 42-day drug administration in the preceding short-term study (Protocol P06124), has exhibited efficacy (CGI-I at the completion of the preceding short-term study of markedly improved, moderately improved, or slightly improved), has no significant safety problems, and has been judged appropriate for study participation by the investigator.
* Male and female participants. Women who are of childbearing potential (i.e., not surgically sterile or post menopausal for at least 1 year) must use medically acceptable birth control. Medically acceptable birth control includes condoms (male or female) with or without a spermicidal agent, diaphragm or cervical cap with spermicide, medically prescribed IUD, insert or copper-containing IUD, hormone-releasing IUD, systemic hormonal contraceptives, and surgical sterilization (eg, hysterectomy or tubal ligation). Male participants must agree to use condoms during their participation in the study.
* Participant must have been explained the nature of the study by the investigator, and be able to provide written consent prior to the conduct of the tests/observation of the clinical study.

Exclusion Criteria:

* A participant must not have any clinically significant abnormal laboratory, vital sign, physical examination, or electrocardiogram (ECG) findings that, in the investigator's opinion, preclude the participant's participation in the study
* A participant must not have a positive pregnancy test or be planning to become pregnant during the term of the study;
* A participant must not receive antipsychotics, antidepressants, mood stabilizers, anti-epileptics, monoamine oxidase inhibitors, St. John's Wort, antiemetics that are dopamine antagonist, or traditional herbal medication for psychiatric symptoms at the baseline;
* A participant must not be at risk of harming themselves or others, in the investigator's opinion;
* A participant must not have been determined to be unsuitable by an investigator.

Primary outcomes:
measure: Percentage of Participants in Categories of Change in Weight From Study P06124 Baseline to Final Assessment
timeFrame: Study P06124 baseline and P06125 study from Day 1 up to Week 52
measure: Percentage of Participants in Categories of Change in Weight From Study P06125 Baseline to Final Assessment
timeFrame: Study P06125 baseline up to Week 52
measure: Change From Study P06124 Baseline in Body Mass Index (BMI) at Week 52
timeFrame: Study P06124 baseline and study P06125 Week 52
measure: Change From Study P06125 Baseline in BMI at Week 52
timeFrame: Study P06125 baseline and Week 52
measure: Number of Participants With Extrapyramidal Symptoms
timeFrame: Up to 30 days after last dose of study drug (Up to approximately 56 weeks)
measure: Change From Study P06124 Baseline in Drug-Induced Extrapyramidal Symptoms Scale (DIEPSS) Total Score at Endpoint
timeFrame: Study P06124 baseline and P06125 study from Day 1 up to Week 52
measure: Change From Study P06125 Baseline in DIEPSS Total Score at Endpoint
timeFrame: Study P06125 baseline up to Week 52
measure: Change From Study P06124 Baseline in DIEPSS Item 9 Score at Endpoint
timeFrame: Study P06124 baseline and P06125 study from Day 1 up to Week 52
measure: Change From Study P06125 Baseline in DIEPSS Item 9 Score at Endpoint
timeFrame: Study P06125 baseline up to Week 52
measure: Change From Study P06124 Baseline in Glycosylated Hemoglobin (HbA1c) at Week 52
timeFrame: Study P06124 baseline and study P06125 Week 52
measure: Change From Study P06125 Baseline in HbA1c at Week 52
timeFrame: Study P06125 baseline and Week 52
measure: Change From Study P06124 Baseline in Fasting Glucose at Week 52
timeFrame: Study P06124 baseline and study P06125 Week 52
measure: Change From Study P06125 Baseline in Fasting Glucose at Week 52
timeFrame: Study P06125 baseline and Week 52
measure: Change From Study P06124 Baseline in Insulin at Week 52
timeFrame: Study P06124 baseline and study P06125 Week 52
measure: Change From Study P06125 Baseline in Insulin at Week 52
timeFrame: Study P06125 baseline and Week 52
measure: Change From Study P06124 Baseline in Prolactin at Week 52
timeFrame: Study P06124 baseline and study P06125 Week 52
measure: Change From Study P06125 Baseline in Prolactin at Week 52
timeFrame: Study P06125 baseline and Week 52
measure: Number of Participants With Serious Adverse Events (AEs)
timeFrame: Up to 30 days after last dose of study drug (Up to approximately 56 weeks)
measure: Number of Participants With Non-serious AEs
timeFrame: Up to 30 days after last dose of study drug (Up to approximately 56 weeks)
measure: Percentage of Participants With Abnormalities on Electrocardiogram (ECG) at Study P06124 Baseline, Study P06125 Baseline and Week 52
timeFrame: Study P06124 baseline and P06125 study baseline and Week 52
measure: Number of Participants Who Took Antiparkinsonian Drugs
timeFrame: P06125 study from Day 1 up to Week 52
measure: Median Time to Loss of Effect in Responders
timeFrame: P06124 study baseline and Day 42, and P06125 study from Day 1 up to Week 52
measure: Median Time to Loss of Effect in Non-Responders
timeFrame: P06124 study baseline and Day 42, and P06125 study from Day 1 up to Week 52
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Director
role: STUDY_DIRECTOR
References: