Schizoaffective DisorderPhase 3NCT00132314

Long-Acting Injectable Risperidone in the Treatment of Schizophrenia

A Phase 3 study testing IM risperidone and oral antipsychotic medication in people with Schizoaffective Disorder and Schizophrenia, run by US Department of Veterans Affairs at 19 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: Schizoaffective Disorder, Schizophrenia
What is being tested?: IM risperidone and oral antipsychotic medication
Type of treatment: Pill or oral medicine, Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 382 participants
Where: 19 sitesUnited States
Study dates: Sep 2006to Sep 2009
Phase: Phase 3
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Age 18 years or older.
Diagnosed with schizophrenia or schizoaffective disorder by the Structured Clinical Interview for Diagnosis (SCID) (Spitzer and First et al., 1996).
Patients should
have been hospitalized in the two years before study entry on a psychiatric inpatient unit, or
document explicit current evidence of increased use of outpatient services such as additional visits, day treatment or non-hospital residential treatment, increased dosage of medications or addition of concomitant psychotropic medications.
The b criterion will promptly be adjudicated by the study chairmen on a case-by case basis to insure credibility.

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.Adequate transportation is available and the participant lives within a travel time of less than 1.5 hours, allowing attendance at all scheduled visits.
Use of an acceptable method of birth control by female patients who have a possibility of becoming pregnant (safety concerns).
Able to demonstrate decisional capacity in order to give informed consent as assessed by the MacArthur Competence Assessment Tool (MacCAT) (Appelbaum and Grisso, 1996). Guardian consent is acceptable where applicable.
Dually diagnosed patients with both schizophrenia and addictive disorders would be included in this study but should not be in need of acute detoxification for physiologic substance dependence (excluding nicotine) in the past 30 days.

Who cannot join

Physiologic substance dependence requiring detoxification (excluding nicotine) in the past 30 days (substance abuse is not an exclusion).
Intolerance of risperidone.
Intolerance of intramuscular injection.
Current treatment with depot antipsychotic medication.
Current treatment with oral clozapine or presence of refractory schizophrenia that, in the treating psychiatrist's opinion, requires clozapine.
Hepatic or renal problems AST or ALT (>2 times upper limit of normal);

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Elevated bilirubin (>1.2), BUN (>24), creatinine (>1.7).
Unstable, serious medical condition or one requiring acute medical treatment, or anticipation of hospitalization for extended care.
Dementia, epilepsy, insulin-dependent diabetes, anticoagulation with coumadin.
Unstable living arrangements or not planning to remain in the area for the next year.
Legal entanglements or pending legal charges with potential of incarceration.
Assault or suicide gesture currently needing acute intervention.
Concurrent participation in another clinical trial with an investigational drug during the last 30 days.
Pregnant or lactating women or women planning to become pregnant.

Trial locations and contacts

19 sites in 1 country.

City, postcode or hospital

19 sites in 1 country

United States19 sites

New Mexico VA Health Care System, Albuquerque
Albuquerque, New Mexico, 87108-5153
VA Medical Center, Augusta
Augusta, Georgia, 30904
VA Medical Center, Jamaica Plain Campus
Boston, Massachusetts, 02130
Jesse Brown VAMC (WestSide Division)
Chicago, Illinois, 60612
VA Medical Center, Cleveland
Cleveland, Ohio, 44106
John D. Dingell VA Medical Center, Detroit
Detroit, Michigan, 48201
Michael E. DeBakey VA Medical Center (152)
Houston, Texas, 77030
VA Medical Center, Kansas City MO
Kansas City, Missouri, 64128
VA Medical Center, Long Beach
Long Beach, California, 90822
VA Medical Center, Miami
Miami, Florida, 33125
VA Medical Center, Minneapolis
Minneapolis, Minnesota, 55417
New York Harbor HCS
New York, New York, 10010
VA Medical Center, Omaha
Omaha, Nebraska, 68105-1873
VA Palo Alto Health Care System
Palo Alto, California, 94304-1290
VA Medical Center, Philadelphia
Philadelphia, Pennsylvania, 19104
VA Puget Sound Health Care System, Seattle
Seattle, Washington, 98108
VA Medical Center, Tuscaloosa
Tuscaloosa, Alabama, 35404
Central Texas Veterans Health Care System - Waco
Waco, Texas, 76711
VA Connecticut Health Care System (West Haven)
West Haven, Connecticut, 06516

Other trials in United States

About this study

Official title: CSP #555 - Long-Acting Injectable Risperidone in the Treatment of Schizophrenia

In the proposed study 450 veterans with a primary diagnosis of schizophrenia who had at least one psychiatric hospitalization for schizophrenia in the previous 2 years would be randomly assigned at 16 VA medical centers to long-acting injectable risperidone or doctor's choice of oral antipsychotic medication (i.e., excluding other long-acting injectable medications, but not specifying any particular oral agents or dosages). Recruitment would take 27 months to complete, and the study would continue for a third year to allow 9 months of follow-up for the last patient recruited. All patients would be treated from the time of entry up to the end of the three-year study period. Follow-up assessments would continue quarterly. Treatments would not be blinded since giving placebo injections to the comparison group would interfere with the goal of comparing the acceptability of two different methods of medication administration. However, end points will be blindly rated.

Read the detailed description

The purpose of the study is to assess the effectiveness of long-acting injectable risperidone on psychiatric inpatient hospitalization, schizophrenia symptoms, quality of life, medication adherence, side effects, and health care costs.

Objectives:

Primary: To evaluate the impact of long-acting intramuscular (IM) risperidone on risk of inpatient psychiatric hospitalization in comparison to standard oral antipsychotic treatment in a randomized controlled trial to be conducted with 450 veterans diagnosed with schizophrenia or schizoaffective disorder at 16 VA medical centers over three years.

Secondary: To evaluate adherence, health benefits, and costs of long-acting IM risperidone as compared to standard oral antipsychotic treatment as measured by: a) symptom reduction over 12 months, b) time to all-cause medication discontinuation, c) quality of life, d) VA and non-VA health service use and related costs, e) medication side effects, f) violent behavior, g) use of concomitant medication, and h) the incremental cost-effectiveness ratio.

Conditions: Schizoaffective Disorder, Schizophrenia
Being tested: IM risperidone, oral antipsychotic medication
Medical subject headings: Psychotic Disorders, Schizophrenia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

IM risperidoneDrug
long-acting injectable risperidone
oral antipsychotic medicationDrug
doctor's choice (excluding other long-acting injectable medications but not specifying any particular oral agents or dosages)

Study groups in NCT00132314
Study group	Role	What they receive
Arm 1	Experimental	long-acting injectable risperidone Receives: Drug: IM risperidone
Arm 2	Active comparator	oral antipsychotic medication Receives: Drug: oral antipsychotic medication

What is being measured

The primary outcome is the main question the study is designed to answer.

Hospitalization-free Survival - Time to Event
A hospitalization-free survival was defined as the time from the date of randomization to the time of a psychiatric hospitalization (in both VA and non-VA hospitals) or, in the case of patients who were hospitalized at randomization, the time from the date of discharge from the initial stay to subsequent hospitalization. Patients without an event were censored at 24 months after the date of randomization.
Measured: From randomization until date of first re-hospitalization, assessed up to 24 months
Hazard Ratio for Hospitalization
Hazard ratio of LAI versus Oral for psychiatric hospitalization (in both VA and non-VA hospitals), after randomization up to 24 months, obtained from a Cox proportional hazards model.
Measured: 24 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Sep 2006Sep 2009

First posted19 Aug 2005 (estimated)
Study startSep 2006
Primary completionSep 2009
Study completionSep 2009

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (6)Papers the sponsor has linked to this study.
Other trials for Schizoaffective DisorderStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 382 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00132314
Sponsor's protocol ID: 555
Status last verified: Oct 2013
First submitted: 17 Aug 2005
Last updated: 20 Dec 2013
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Publications

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. doi: 10.1177/1740774510392931. Epub 2011 Jan 26.
PubMed 21270143
Rosenheck RA, Krystal JH, Lew R, Barnett PG, Fiore L, Valley D, Thwin SS, Vertrees JE, Liang MH; CSP555 Research Group. Long-acting risperidone and oral antipsychotics in unstable schizophrenia. N Engl J Med. 2011 Mar 3;364(9):842-51. doi: 10.1056/NEJMoa1005987.
PubMed 21366475
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. doi: 10.1016/j.schres.2011.03.033. Epub 2011 Apr 22.
PubMed 21514794
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. doi: 10.4088/JCP.11m07070.
PubMed 22697193
Thwin SS, Hermes E, Lew R, Barnett P, Liang M, Valley D, Rosenheck R. Assessment of the minimum clinically important difference in quality of life in schizophrenia measured by the Quality of Well-Being Scale and disease-specific measures. Psychiatry Res. 2013 Oct 30;209(3):291-6. doi: 10.1016/j.psychres.2013.01.016. Epub 2013 Mar 7.
PubMed 23473656
Hoblyn JC, Rosenheck RA, Leatherman S, Weil L, Lew R; CSP 555 Investigator Group. Veteran subjects willingness to participate in schizophrenia clinical trials. Psychiatr Q. 2013 Jun;84(2):209-18. doi: 10.1007/s11126-012-9240-4.
PubMed 23143523

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 20 Dec 2013. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: CSP #555 - Long-Acting Injectable Risperidone in the Treatment of Schizophrenia
ClinicalTrials.gov ID: NCT00132314
Acronym / sponsor ID: 555
Conditions: Schizoaffective Disorder, Schizophrenia
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 382 participants (actual)
Lead sponsor: US Department of Veterans AffairsUS federal agency
Study start: Sep 2006
Primary completion: Sep 2009 (actual)
Study completion: Sep 2009 (actual)
First posted: 19 Aug 2005 (estimated)
Results: Posted 20 Dec 2013

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Objectives:

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Arm 1	Experimental	Drug: IM risperidonelong-acting injectable risperidone
Arm 2	Active comparator	Drug: oral antipsychotic medicationoral antipsychotic medication

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (10 listed)

Age 18 years or older.
Diagnosed with schizophrenia or schizoaffective disorder by the Structured Clinical Interview for Diagnosis (SCID) (Spitzer and First et al., 1996).
Patients should
The b criterion will promptly be adjudicated by the study chairmen on a case-by case basis to insure credibility.
.Adequate transportation is available and the participant lives within a travel time of less than 1.5 hours, allowing attendance at all scheduled visits.

Key exclusion criteria (14 listed)

Physiologic substance dependence requiring detoxification (excluding nicotine) in the past 30 days (substance abuse is not an exclusion).
Intolerance of risperidone.
Intolerance of intramuscular injection.
Current treatment with depot antipsychotic medication.
Current treatment with oral clozapine or presence of refractory schizophrenia that, in the treating psychiatrist's opinion, requires clozapine.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
IM risperidonelong-acting injectable risperidone	Drug	Arm 1
oral antipsychotic medicationdoctor's choice (excluding other long-acting injectable medications but not specifying any particular oral agents or dosages)	Drug	Arm 2

Primary outcome

Hospitalization-free Survival - Time to Event
Time frame: From randomization until date of first re-hospitalization, assessed up to 24 months
A hospitalization-free survival was defined as the time from the date of randomization to the time of a psychiatric hospitalization (in both VA and non-VA hospitals) or, in the case of patients who were hospitalized at randomization, the time from the date of discharge from the initial stay to subsequent hospitalization. Patients without an event were censored at 24 months after the date of randomization.
Hazard Ratio for Hospitalization
Time frame: 24 months
Hazard ratio of LAI versus Oral for psychiatric hospitalization (in both VA and non-VA hospitals), after randomization up to 24 months, obtained from a Cox proportional hazards model.

Results and safety

Results posted to the registry on 20 Dec 2013, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Injectable Risperidone	190	117
Oral Antipsychotic	192	120

Primary outcome: Hospitalization-free Survival - Time to Event

Time frame: From randomization until date of first re-hospitalization, assessed up to 24 months. Median (95% Confidence Interval). Unit: years

Measure	Injectable Risperidone n = 187	Oral Antipsychotic n = 182
Value	NA (1.84 to NA)	1.97 (1.19 to NA)

Injectable Risperidone vs Oral Antipsychotic: Hazard Ratio (HR): 0.87 (95% CI 0.63 to 1.20), p = 0.39, Log Rank

Primary outcome: Hazard Ratio for Hospitalization

Time frame: 24 months. Number. Unit: participants

Measure	Injectable Risperidone n = 187	Oral Antipsychotic n = 182
Patients with psychiatric hospitalization	72	81
Patients without psychiatric hospitalization	115	101

Injectable Risperidone vs Oral Antipsychotic: Hazard Ratio (HR): 0.87 (95% CI 0.63 to 1.20), Regression, Cox

Adverse events

Time frame: Adverse events were collected from enrollment to 30 days after the end of follow-up. Subjects were followed for up to 36 months, depending on when the participant was enrolled in the study.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Injectable Risperidone	96 of 187 (51.3%)	132 of 187 (70.6%)	Not reported
Oral Antipsychotic	91 of 182 (50%)	123 of 182 (67.6%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 20 Dec 2013.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Results publication: PubMed 21270143Rosenheck 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. doi: 10.1177/1740774510392931. Epub 2011 Jan 26.
Results publication: PubMed 21366475Rosenheck RA, Krystal JH, Lew R, Barnett PG, Fiore L, Valley D, Thwin SS, Vertrees JE, Liang MH; CSP555 Research Group. Long-acting risperidone and oral antipsychotics in unstable schizophrenia. N Engl J Med. 2011 Mar 3;364(9):842-51. doi: 10.1056/NEJMoa1005987.
Results publication: PubMed 21514794Barnett 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. doi: 10.1016/j.schres.2011.03.033. Epub 2011 Apr 22.
Results publication: PubMed 22697193Barnett 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. doi: 10.4088/JCP.11m07070.
Results publication: PubMed 23473656Thwin SS, Hermes E, Lew R, Barnett P, Liang M, Valley D, Rosenheck R. Assessment of the minimum clinically important difference in quality of life in schizophrenia measured by the Quality of Well-Being Scale and disease-specific measures. Psychiatry Res. 2013 Oct 30;209(3):291-6. doi: 10.1016/j.psychres.2013.01.016. Epub 2013 Mar 7.
Derived from this study: PubMed 23143523Hoblyn JC, Rosenheck RA, Leatherman S, Weil L, Lew R; CSP 555 Investigator Group. Veteran subjects willingness to participate in schizophrenia clinical trials. Psychiatr Q. 2013 Jun;84(2):209-18. doi: 10.1007/s11126-012-9240-4.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Robert A. Rosenheck, AB MD study chair

VA Connecticut Health Care System (West Haven)

19 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 20 Dec 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 19 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 20 Dec 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Hospitalization-free Survival - Time to Event (time frame: From randomization until date of first re-hospitalization, assessed up to 24 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00132314, which also lists 6 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Dec 2013; AzTrials last refreshed its copy on 7 Nov 2026.