Does Risperidone Consta Reduce Relapse and Rehospitalization in Bipolar Disorder?

NCT00571688 | Completed Phase 4 Results DMC FDA Drug

• 1 other identifier: RIS-BIP-4005
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

This study will evaluate the relative effectiveness of risperidone Consta injections occurring every 2 weeks in contrast to treatment as usual in preventing symptomatic relapse and rates of rehospitalization or admission into respite care for bipolar patients. Hypothesis: Risperdal Consta injections every 2 weeks will reduce the number of symptomatic relapses into mania, hypomania, mixed state, or depression, as shown by key indicators that include symptomatic relapse, rehospitalizations, emergency or urgent care visits, respite care, and intensive outpatient treatment as compared to treatment as usual.

Conditions

Bipolar Disorder

Keywords

Bipolar Disorder; Depression, Bipolar; Mania

Outcome Measures

Primary Outcomes (1)

• Number of Relapse-related Events Normalized to Unit Time

  The outcome was total number of events divided by number of months (normalized to unit time). This was be calculated by dividing the number of relapse related events by the number of months of participation. Relapse related events included: (1) YMRS score \> 14 or MADRS \> 15; (2) 20% or greater increase in the YMRS or MADRS scores from the previous study visit; (3) urgent care visit (psychiatric hospitalization; emergency department visit; referral for respite care, partial hospitalization, or intensive outpatient treatment) due to worsening mood symptoms; (4) a Clinical Global Impression Severity of Illness score \>3; (5) syndromal relapse (Diagnostic and Statistical Manual of Mental Disorders, 4th Editionfor manic, hypomanic, major depressive, or mixed episode met); (6) withdrawal from the study due to inefficacy; and (7) necessary clinical medication adjustments (NCAs).

  12 months

Study Arms (2)

Risperdal Consta

EXPERIMENTAL

Risperdal Consta injection in conjunction with existing treatment

Drug: Risperdal (risperidone) Consta

Treatment As Usual

ACTIVE COMPARATOR

Clinician and patient decide upon treatment, as in a non-research clinical setting. The only treatment exclusion is any form of risperidone.

Drug: Treatment as usual

Interventions

Risperdal (risperidone) Consta DRUG

Risperdal Consta (TM) will be administered every 2 weeks by deep intramuscular (IM) gluteal injection, by a trained health care professional. Injections will alternate between the two buttocks. The initial dose will be 25 mg IM every 2 weeks. A minimum dose of 25 mg. every 2 weeks will be maintained. At the clinician's discretion, the dose may be advanced to 37.5 mg. or 50 mg. In addition, the dose will be raised to 37.5 mg. or 50 mg. if the following conditions remain: (1) Young Mania Rating Scale (YMRS) score \> 12; or (2) Evidence of impending relapse; and no dose limiting side effect. If the 25 mg. dose is not tolerated, the dose can be held temporarily; however, attempts will be made to achieve and maintain the dose at 25 mg. (or higher) until the end of the study period.

Also known as: Risperidone long-acting injectible

Risperdal Consta

Treatment as usual DRUG

Treatment was provided in this arm based solely on the choice of the treatment provider and participant. Treatment providers were not part of the study staff and were completely free to make treatment choices except that they were not allowed to select a long-acting injectible.

Also known as: Usual care

Treatment As Usual

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Be physically healthy
• years of age
• Have a DSM-IV diagnosis of bipolar disorder in any phase, but without current psychotic features; with a history of symptomatic relapse on four or more occasions over the last year prior to the initiation of study for the treatment of bipolar disorder (type I or II, manic, hypomanic, mixed, or depressive type), with at least 1 in the previous 6 months.
• Have a screening Hamilton Rating Scale for Depression-17 item (HAM-D17) score of \> 8 or a Young Mania Rating Scale (YMRS) \> 8.

You may not qualify if:

• Have any medical condition that would preclude treatment with Risperdal Consta(TM)
• Have type 2 diabetes
• Have hyperlipidemia (baseline total cholesterol \>280)
• Have any clinically significant unstable medical condition
• Have currently active psychotic symptoms (hallucinations or delusions) or carry a diagnosis of another psychotic disorder (schizophrenia, schizoaffective disorder, delusional disorder)
• Have a documentable history of non-response to Risperidal Consta (TM)
• Have a score of 4 on the suicide item (item 3) of the HAM-D scale and/or a determination by the investigator of significant suicide risk
• Require hospitalization between the screening and baseline visits, or require hospitalization immediately following baseline
• Have a medical contraindication or hypersensitivity to risperidone or Risperdal Consta (TM)

Sponsors & Collaborators

• Vanderbilt University: lead
• Ortho-McNeil Janssen Scientific Affairs, LLC: collaborator

Study Sites (1)

Mental Health Cooperative, Inc.

Nashville, Tennessee, 37228, United States

Location

MeSH Terms

Conditions

Bipolar Disorder; Mania

Interventions

Risperidone; Therapeutics

Condition Hierarchy (Ancestors)

Bipolar and Related Disorders; Mood Disorders; Mental Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Pyrimidinones; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Limitations and Caveats

This was not a blinded study.

Results Point of Contact

• Title: Tracy Manley
• Organization: University of Alabama at Birmingham

tlmanley@uabmc.edu

205-975-3442

Study Officials

• Richard C Shelton, M.D.

  Vanderbilt University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: December 11, 2007
• First Posted: December 12, 2007
• Study Start: November 1, 2007
• Primary Completion: February 1, 2009
• Study Completion: February 1, 2009
• Last Updated: July 31, 2017
• Results First Posted: July 31, 2017

Record last verified: 2017-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)