CSP #555: Long-Acting Risperidone and Oral Antipsychotics in Unstable Schizophrenia - VA Cooperative Studies Program (CSP)
Attention A T users. To access the menus on this page please perform the following steps. 1. Please switch auto forms mode to off. 2. Hit enter to expand a main menu option (Health, Benefits, etc). 3. To enter and activate the submenu links, hit the down arrow. You will now be able to tab or arrow up or down through the submenu options to access/activate the submenu links.

VA Cooperative Studies Program (CSP)

Menu
Menu

Quick Links

Veterans Crisis Line Badge
My healthevet badge
EBenefits Badge
 

CSP #555: Long-Acting Risperidone and Oral Antipsychotics in Unstable Schizophrenia



Investigator Access

What's available

Research data

Available documentation 

Contact Lauren.Harris2@va.gov

Dates data are available 

Currently available

Access criteria

Investigators associated with VA or non-VA nonprofit, academic, or research institutions may submit a Research Resource Request form to Lauren.Harris2@va.gov. Investigators may be asked to provide further documentation such as a study proposal.

All requests are reviewed for scientific and ethical merit. Access is contingent upon approval by the requestor’s Institutional Review Board (IRB) and, if applicable, a VA Research and Development (R&D) Committee. To gain access, requestors must sign a VA data use agreement. Requestors must be fully compliant with VA data security, privacy, and human subjects requirements.

Study Characteristics

Objectives

Primary: to evaluate the impact of long-acting intramuscular risperidone on risk of inpatient psychiatric hospitalization in comparison to standard oral antipsychotic treatment in veterans with schizophrenia or schizoaffective disorder

Secondary: to evaluate adherence, health benefits, and costs of long-acting intramuscular risperidone as compared to standard oral antipsychotic treatment as measured by:

  • symptom reduction over 12 months
  • time to all-cause medication discontinuation
  • quality of life
  • VA and non-VA health service use and related costs
  • medication side effects
  • violent behavior
  • use of concomitant medication
  • incremental cost-effectiveness ratio

Era of Service

All

Population

Veterans diagnosed with schizophrenia or schizoaffective disorder based on the fourth edition of the Diagnostic and Statistical Manual of Mental Disorders (DSM-IV) at risk for hospitalization (91% male, mean age 51) 

Study Design

Randomized controlled trial with no blinding

Intervention 

  • Long-acting injectable intramuscular risperidone
  • Control group continued standard oral treatment

Time Period

September 2006 - September 2009

Setting

National

N

369

Response Rate

69.5% (369 out of 531 eligible for participation)

Recruitment Method

Inpatients and outpatients with schizophrenia or schizoaffective disorder diagnosis were identified from VA discharge abstracts, with the patients’ Social Security Number were sent to the participating sites. Physicians treating the patients invited them to participate, and patients were screened for eligibility.

Compensation

  • $25 for monthly injection visits
  • $45 for extended quarterly assessment visits

Data Collected

  • Hospitalization-free survival (time from date of randomization to date of hospitalization)
  • Clinical Global Impressions (CGI) scale of mental health status
  • Questionnaires for measuring quality of life, satisfaction with medication, symptoms, anxiety, depression, substance abuse, social functioning, and side effects
  • Administrative data on health service use, adverse events and mortality

Data Collection Methods

  • Questionnaire
  • Administrative data
  • Blinded videoconference assessments

Funding Source

  • VA Cooperative Studies Program (CSP)
  • Ortho-McNeil Janssen Scientific Affairs

Contact

Lauren.Harris2@va.gov

Selected Publication

Rosenheck, RA, Krystal JH, Lew R, Barnett PG, Fiore L, Valley D, Thwin SS, Vertrees JE, Liang MH; CSP 555 Research Group. Long-Acting Risperidone and Oral Antipsychotics in Unstable Schizophrenia. N Engl J Med. 2011; 364(9): 842-51.

Rosenheck RA, Krystal JH, Lew R, Barnett PG, Thwin SS, Fiore L, Valley D, Huang GD, Neal C, Vertrees JE, Liang MH; CSP 555 Research Group. Challenges in the design and conduct of controlled clinical effectiveness trials in schizophrenia. Clin Trials. 2011 Apr;8(2):196-204

Barnett PG, Scott JY, Rosenheck RA; CSP 555 Study Group. How do clinical trial participants compare to other patients with schizophrenia? Schizophr Res. 2011 Aug;130(1-3):34-9.

Barnett PG, Scott JY, Krystal JH, Rosenheck RA; CSP 555 Research Group. Cost and cost-effectiveness in a randomized trial of long-acting risperidone for schizophrenia. J Clin Psychiatry. 2012 May;73(5):696-702.

More Information

ClinicalTrials.gov Identifier: NCT00132314