Bipolar Disorder Clinical Trial
Official title:
A Randomized, Double-Blind, Active- and Placebo-controlled, Parallel-group, Multicenter Study to Evaluate the Efficacy and Safety of Extended-Release Paliperidone as Maintenance Treatment After an Acute Manic or Mixed Episode Associated With Bipolar I Disorder
The purpose of this study is to evaluate the effectiveness and safety of oral extended-release (ER) paliperidone compared with placebo in the prevention of the recurrence of mood symptoms in patients with Bipolar I Disorder who initially respond to treatment of an acute manic or mixed episode with paliperidone ER. Olanzapine was included as an active control arm, although the study is not designed to allow for a direct comparison of olanzapine with paliperidone.
This is a randomized (patients are assigned different treatments based on chance),
double-blind (neither the patient nor the physician knows whether drug or placebo is being
taken), active- and placebo-controlled, parallel-group, multicenter study to evaluate the
efficacy (effectiveness) and safety of paliperidone ER relative to placebo in the prevention
of recurrent mood symptoms associated with Bipolar I Disorder.
There are 5 phases in this study: a screening phase (lasting up to 7 days) to establish a
subject's eligibility for the study,; a 3-week double-blind acute treatment phase to treat
the acute or manic episode; a 12-week double-blind treatment continuation phase to establish
a patient's clinical stability,; a double-blind treatment maintenance phase to measure the
time to symptom recurrence that will last until the patient experiences a recurrence,; and a
follow-up phase consisting of a visit approximately 1 week after the last study visit. All
antipsychotic drugs and all mood stabilizers other than study drug must be discontinued
before the first study drug administration.
Hospitalization is required for at least the first 7 days of the acute treatment phase. At
the beginning of the acute treatment phase, patients will be randomly assigned to receive ER
paliperidone or olanzapine in a 4:1 ratio. Patients in the ER paliperidone group who have a
clinical response at the end of the acute treatment phase, remain clinically stable
throughout the continuation phase, and achieve remission for each of the last 3 weeks of the
continuation phase will again be randomly assigned: they will be assigned in a 1:1 ratio to
receive ER paliperidone or placebo in the maintenance phase. Patients in the olanzapine
treatment group who fulfill the same criteria will continue receiving double-blind treatment
with olanzapine in the maintenance phase.
Measures of efficacy used are the Young Mania Rating Scale (YMRS), Montgomery-Åsberg
Depression Rating Scale (MADRS), Clinical Global Impression - Bipolar Disorder - Severity of
Illness Scale (CGI-BP-S), Global Assessment of Functioning (GAF), the Short Form-36 to
measure health-related functional status, and the sleep visual analog scale (VAS).
Safety evaluations include monitoring of adverse events, clinical laboratory tests
(including urine pregnancy testing and hemoglobin A1c), 12-lead ECG, vital signs
measurements, measurement of orthostatic changes in pulse and blood pressure, physical
examinations (including height, body weight, and waist circumference), and monitoring of
extrapyramidal symptoms using the Abnormal Involuntary Movement Scale (AIMS), the Barnes
Akathisia Rating Scale (BARS), and the Simpson Angus Scale (SAS). In addition, the Scale for
Suicidal Ideation will be administered to assess suicidality.
The primary hypothesis for this study is that, during the long-term treatment of patients
with Bipolar I Disorder who maintain clinical stability after an acute manic or mixed
episode, ER paliperidone is superior to placebo in delaying the time to recurrence of any
mood symptoms associated with Bipolar I Disorder. Patients begin the acute treatment phase
at 6.0 mg/day of oral ER paliperidone or 10 mg/day of oral olanzapine. Dosages may be
adjusted, as needed, between 3 to 12 mg/day of ER paliperidone or 5 to 20 mg/day of
olanzapine, through the end of the continuation phase. Then, in the maintenance phase,
patients receive the dosage of ER paliperidone (or ER paliperidone placebo) or olanzapine
reached at the end of the continuation phase. They remain on those dosages until the end of
the study.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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