NCT00094926

Brief 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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
275

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started May 2004

Typical duration for phase_3

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2004

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

October 28, 2004

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 29, 2004

Completed
2.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2007

Completed
Last Updated

May 19, 2011

Status Verified

April 1, 2010

First QC Date

October 28, 2004

Last Update Submit

May 17, 2011

Conditions

Bipolar Disorder

Keywords

Risperidal CONSTABipolar disordermood episodesSafety and efficacy, adjuvant therapy

Outcome Measures

Primary Outcomes (1)

  • 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.

    52 weeks

Secondary Outcomes (1)

  • 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)

    52 weeks

Study Arms (2)

001

EXPERIMENTAL
Drug: Risperdal Consta

002

PLACEBO COMPARATOR
Drug: placebo

Interventions

Risperdal ConstaDRUG

25, 37.5 or 50mg IM injections every 2wks for 52wks

001
placeboDRUG

matching placebo IM injections every 2wks for 52wks

002

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Macfadden W, Alphs L, Haskins JT, Turner N, Turkoz I, Bossie C, Kujawa M, Mahmoud R. A randomized, double-blind, placebo-controlled study of maintenance treatment with adjunctive risperidone long-acting therapy in patients with bipolar I disorder who relapse frequently. Bipolar Disord. 2009 Dec;11(8):827-39. doi: 10.1111/j.1399-5618.2009.00761.x.

    PMID: 19922552DERIVED

Related Links

MeSH Terms

Conditions

Bipolar Disorder

Interventions

Risperidone

Condition Hierarchy (Ancestors)

Bipolar and Related DisordersMood DisordersMental Disorders

Intervention Hierarchy (Ancestors)

PyrimidinonesPyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Johnson & Johnson Pharmaceutical Research and Development, L.L.C. Clinical Trial

    Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

October 28, 2004

First Posted

October 29, 2004

Study Start

May 1, 2004

Study Completion

February 1, 2007

Last Updated

May 19, 2011

Record last verified: 2010-04