Long-term Extension Trial of Asenapine in Subjects With Schizophrenia (Study P06125)
Information source: Merck Sharp & Dohme Corp.
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Schizophrenia
Intervention: Asenapine (Drug); Asenapine (Drug)
Phase: Phase 3
Status: Completed
Sponsored by: Merck Sharp & Dohme Corp.
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), 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 bid in core
trial P06124 will get placebo for the first 2 weeks then 5 mg asenapine 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 twice daily (bid) or asenapine 10 mg bid
Participants who were on asenapine 10 mg twice daily (bid) in core trial P06124 will be
re-randomized after Week 6 to asenapine 5 mg bid or asenapine 10 mg bid
Clinical Details
Official title: Long-term Extension Trial of Asenapine in Subjects With Schizophrenia (Phase 3 ; Protocol No. P06125)
Study design: Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Primary outcome: Weight gain/loss from baselineChange in Body Mass Index (BMI) from baseline Occurrences of extrapyramidal symptoms (EPS) Change in fasting glucose from baseline Change in insulin from baseline Changes in prolactin level from baseline Occurrences of serious and non-serious adverse events Participants who had findings on physical exam out of normal range Participants who had vital sign findings out of normal range Participants who had abnormal electrocardiogram (ECG) findings Occurrences of abnormal laboratory findings Change in drug-induced extrapyramidal symptom scale (DIEPSS) from baseline Number of participants taking anti-Parkinson drugs Amount of anti-Parkinson drugs Change in glycosylated hemoglobin (HbA1c) from baseline
Eligibility
Minimum age: 20 Years.
Maximum age: 64 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Participant has completed 42-day drug administration in the preceding short-term
study (Protocol P06124), has exhibited efficacy (aCGI-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 agonist, 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.
Locations and Contacts
Additional Information
Starting date: May 2010
Last updated: August 18, 2015
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