Risperdal Consta for Bipolar Disorder

NCT00177164 | Completed Phase 3 Results DMC

• 2 other identifiers: RIS-PSY-405Univ. Pittsburgh IRB #0403091
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 4

Brief Summary

We recruited 50 consenting adult subjects with DSM-IV TR diagnoses of bipolar disorder who were about to initiate or switch their current antipsychotic agent. Only 48 patients (23 in the risperidone LAI group and 25 in the oral AAP group) contributed data to the assessments. Patients were titrated and cross-tapered during a 3 month titration and stabilization phase. They were followed for an additional 12 months. Clinical outcomes such as study drop out, adverse events, worsening of symptoms, crisis interventions, need for additional medication, hospitalizations etc. were evaluated from months 3 to 15. The numbers of clinical events (pooled) will be used to evaluate if the long acting injectable form of risperidone has an advantage over the oral second generation antipsychotic agents in terms of treatment continuity and clinical stability.

Conditions

Bipolar I Disorder

Keywords

Bipolar I Disorder; Risperidone Consta - Long Acting Injection; Oral second generation antipsychotic agents

Outcome Measures

Primary Outcomes (1)

• Evaluate the Number of Clinical Events (Pooled) Occurring Between 3-15 Months Following a Switch/Stabilization of the Antipsychotic Agents Among Patients Who Receive Either Risperidal Consta or One of the 4 Marketed 2nd Generation Antipsychotic Agents.

  Upto 15 months

Secondary Outcomes (3)

• BMI

  baseline to end of 15 months

• Number of Participants With Treatment - Emergent Hyperglycemia

  from baseline to end of 15 months

• Number of Participants With Treatment Emergent Hyperlipidemia

  from baseline to end of 15 months

Study Arms (2)

1

ACTIVE COMPARATOR

Oral Risperidone followed by Long acting Risperidone injections (Consta)

Drug: Injectable Risperidone (Consta) or oral antipsychotic

2

ACTIVE COMPARATOR

Oral second generation antipsychotic agents other than clozapine or risperidone (olanzapine, quetiapine, ziprasidone, aripiprazole)

Drug: Injectable Risperidone (Consta) or oral antipsychotic

Interventions

Injectable Risperidone (Consta) or oral antipsychotic DRUG

Injectable Risperidone (Consta) from 12.5 to 50 mg q 2 weeks Oral antipsychotic agents, olanzapine, quetiapine, ziprasidone, aripiprazole in doses approved in the US for bipolar disorder

Also known as: Long actiing risperidone injection (Consta), oral risperidone (risperdal)., Olanzapine (Zyprexa), Quetiapine (Seroquel), Ziprasidone (Geodon), Aripiprazole (Ablify)

1; 2

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• DSM-IV - TR diagnoses of bipolar disorder (I or II or NOS).
• Age 18 to 70 years
• Men or women
• Any Ethnicity
• Currently receiving or willing to receive treatment at sites associated with the Western Psychiatric Institute and Clinic -University of Pittsburgh Medical Center (inpatient or ambulatory) or Mon Yough Community Services, Inc. or at Mayview State Hospital, Bridgeville, PA (inpatient)
• Able to provide competent and sign an informed consent document
• It is clinically appropriate in the eligible individual to consider antipsychotic treatment for at least 15 months (clinician and investigator determined)
• It is clinically appropriate to switch antipsychotic treatment to one of the second generation antipsychotic agents being evaluated in this study.
• There is no known contraindication for the use of either risperidone or for more than two of the antipsychotic agents being considered in the study (Investigator determined)
• At entry (at the screening visit, and just prior to randomization) Y-MRS (Young-Mania rating scale, Young et al., 1978) total score \> 15 in bipolar disorder patients entering in a manic or mixed or hypomanic or NOS episode.
• Either life-time or current comorbid substance abuse or dependence is permitted (unless the Investigator and referring physician opines the substance abuse is likely to significantly interfere with either the diagnosis of the Axis I condition or to compromise patients safety due to withdrawal issues (Investigator determined).
• Screening physical and laboratory/EKG procedures are within acceptable limits

You may not qualify if:

• Actively suicidal or dangerous to others (Investigator opines that it is inappropriate to involve the potential subject in the study)
• Pregnant or lactating women
• Women in the reproductive age group who are not using any acceptable contraception (abstinence is not acceptable) or intend to become pregnant during the trial
• Subjects who are likely to face incarceration during the study duration (and for those already in the study, the continued participation of such subjects will be evaluated on a case-by-case basis)
• Patients currently receiving clozapine (or within six weeks prior to randomization) are ineligible for the study
• Subjects currently receiving a depot neuroleptic injectable agent, or within 2 injection cycles of receiving the injection prior to randomization.
• Allergy or serious side effects (for instance - neuroleptic malignant syndrome) to either risperidone or to more than two of the other second-generation antipsychotic agents that have been approved for use in the U.S.A. (olanzapine, quetiapine, ziprasidone, aripiprazole-per investigator and referring clinician).
• Treatment resistance to either risperidone, or to more than two of the other antipsychotic agents in this trial (olanzapine, quetiapine, ziprasidone, aripiprazole).
• This is the first episode of mania, mixed or hypomania for patients.
• Current (or within one month prior to randomization) participation in an investigational drug/device study.
• Currently participating in another study that would confound the present study objectives (per investigator)

Sponsors & Collaborators

• University of Pittsburgh: lead
• Janssen Pharmaceuticals: collaborator

Study Sites (4)

Mayview State Hospital

Bridgeville, Pennsylvania, 15017-1599, United States

Location

Dubois Regional Medical Center

DuBois, Pennsylvania, 15801, United States

Location

Mon-Yough Community Services, Inc.

McKeesport, Pennsylvania, 15132, United States

Location

Western Psychiatric Institute and Clinic

Pittsburgh, Pennsylvania, 15213-2593, United States

Location

Related Publications (1)

• Chengappa KN, Turkin SR, Schlicht PJ, Murphy SL, Brar JS, Fagiolini A, Houck PR, Garbutt RG, Fredrick N. A Pilot, 15-month, randomised effectiveness trial of Risperidone long-acting injection (RLAI) versus oral atypical antipsychotic agents (AAP) in persons with bipolar disorder. Acta Neuropsychiatr. 2010 Apr;22(2):68-80. doi: 10.1111/j.1601-5215.2010.00458.x.

  PMID: 25385032 RESULT

MeSH Terms

Interventions

Risperidone; Olanzapine; Quetiapine Fumarate; ziprasidone; Aripiprazole

Intervention Hierarchy (Ancestors)

Pyrimidinones; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Benzodiazepines; Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Dibenzothiazepines; Thiazepines; Thiepins; Sulfur Compounds; Organic Chemicals; Heterocyclic Compounds, 3-Ring; Piperazines; Quinolones; Quinolines

Results Point of Contact

• Title: K.N. Roy Chengappa
• Organization: UPMC

chengappakn@upmc.edu

412-246-5006

Study Officials

• K.N. Roy Chengappa, MD

  Western Psychiatric Institute and Clinic

  PRINCIPAL INVESTIGATOR

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Psychiatry

Study Record Dates

• First Submitted: September 12, 2005
• First Posted: September 15, 2005
• Study Start: November 1, 2003
• Primary Completion: March 1, 2008
• Study Completion: December 1, 2009
• Last Updated: April 19, 2016
• Results First Posted: February 8, 2016

Record last verified: 2016-03

Locations

US (4)