A Study of Effectiveness and Safety of Risperdal CONSTA Added to Usual Treatment in Patients With Bipolar Disorder Who Have Frequent Mood Episodes.
Information source: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Bipolar Disorder
Intervention: Risperdal Consta (Drug); placebo (Drug)
Phase: Phase 3
Status: Completed
Sponsored by: Johnson & Johnson Pharmaceutical Research & Development, L.L.C. Official(s) and/or principal investigator(s): Johnson & Johnson Pharmaceutical Research and Development, L.L.C. Clinical Trial, Study Director, Affiliation: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Summary
The purpose of this study is to examine the safety and effectiveness of the long acting
injectable form of the atypical antipsychotic Risperidone (Risperdal CONSTA), along with
treatment as usual (TAU), in bipolar disorder patients who had more than 4 mood episodes in
the past year.
Clinical Details
Official title: A Prospective, Randomized, Double-blind, Placebo-controlled Study of the Effectiveness and Safety of RISPERDAL CONSTA Augmentation in Adult Patients With Frequently-relapsing Bipolar Disorder
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Primary outcome: Efficacy will be determined by measuring the time (in days) from randomization to event/relapse; relapse will be assessed by clinical status, rating scale changes, and pharmacologic stability in double-blind phase.
Secondary outcome: Safety and tolerability as assessed by adverse event reports (every 2 weeks), scores on movement disorder measures, laboratory parameters, vital signs, ECG measures and physical examination reports (every 2-3 months)
Detailed description:
Frequently-relapsing (more than 4 episodes in the last year) bipolar patients are a
sub-group of patients who have multiple mood episodes in spite of treatment. Currently
available treatments may have little impact on number and frequency of manic and/or
depressed mood episodes and as a result, these patients have higher than average rates of
illness and death. This study examines the effectiveness and side effects of risperidone
long-acting injections (LAI) added to treatment as usual (TAU) in frequently-relapsing
bipolar patients. The study has two main phases. The first phase is open-label (patients and
doctors know what medication and dose the patient is receiving- both risperidone LAI and
TAU) and lasts 16 weeks. During that time, patients are treated with the goal that they
reach "remission", a predefined level of improvement (decrease in number and severity of
mood episodes.) Patients who meet remission criteria at the end of the first phase are
randomized (like flipping a coin) to either continue receiving the same dose of risperidone
LAI plus TAU, or placebo injections plus TAU. Patients continue in the second phase for 52
weeks, during which time the effectiveness is measured by time to "relapse" (worsening of
mood symptoms severe enough to require hospitalization or a major change in medication.)
Additional effectiveness, safety, and side effect measures are evaluated throughout the
length of the study.
Long-acting risperidone injection 25 mg will be administered every two weeks through a
gluteal injection for at least one month. Thereafter, the dose may be increased to 37. 5mg
then to 50 mg based on clinical response and tolerability. Supplemental use of oral
Risperdal (1 to 2 mg/day) will be permitted during the first 12 weeks of the Open-Label
Stabilization Phase. Patients must be taking a stable dose of risperidone LAI for the 4
weeks immediately prior to entering the Double-Blind Phase.
Eligibility
Minimum age: 18 Years.
Maximum age: 70 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Must provide informed consent
- Must agree to receive regular injections
- Must have current diagnosis of bipolar disorder I or II
- Must have at least four episodes of mood disorder in the last year that required
psychiatric intervention
Exclusion Criteria:
- Female who is or may be pregnant or breastfeeding, who is not at least 1 year
postmenopausal, or is not using reliable and adequate birth control
- Psychiatric diagnosis is due directly to effects of a substance or general medical
condition
- Substance dependence
- Received treatment with a long-acting injectable antipsychotic less than 2 injection
cycles prior to baseline (so, for example, if the drug is injected every 2 weeks, the
patient could not enroll in the study if they had received an injection within the
last 4 weeks)
- Received Electroconvulsive Therapy (ECT) within the last month
- Began psychotherapy ("talk therapy") within 2 months
- In the past month was treated with any of these medications: carbamazepine,
oxcarbazepine, fluoxetine, paroxetine, or clozapine
Locations and Contacts
Additional Information
Adjunctive Risperdal Consta Study in Frequently Relapsing Bipolar Disorder Patients
Starting date: May 2004
Last updated: May 17, 2011
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