Schizoaffective DisorderPhase 4NCT00007774
To Determine if Olanzapine is More Cost Effective Than Haloperidol for the Treatment of Schizophrenia
A Phase 4 study testing Haloperidol and Olanzapine in people with Schizoaffective Disorder and Schizophrenia, run by US Department of Veterans Affairs at 18 sites in United States.
Trial summary
Although currently marketed antipsychotic drugs are useful in the treatment of schizophrenia, efficacy and safety profiles need to be improved. Forty to eighty percent of patients either fail to respond or only partially respond to conventional antipsychotic agents. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Schizoaffective Disorder, Schizophrenia
- What is being tested?
- Haloperidol and Olanzapine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 600 participants
- Where
- 18 sitesUnited States
- Study dates
- Mar 1998to Jun 2001
- Phase
- Phase 4
- Are there results?
- None posted in the registry
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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients with schizophrenia or schizoaffective disorder.
Who cannot join
None listed.
Trial locations and contacts
18 sites in 1 country.
18 sites in 1 country
United States18 sites
New Mexico VA Health Care System, Albuquerque
Albuquerque, New Mexico, 87108-5153
VA Medical Center, Augusta
Augusta, Georgia, 30904
VA Medical Center, Bay Pines
Bay Pines, Florida, 33708
Edith Nourse Rogers Memorial Veterans Hospital, Bedford
Bedford, Massachusetts, 01730
VA Medical Center, Cleveland
Cleveland, Ohio, 44106
John D. Dingell VA Medical Center, Detroit
Detroit, Michigan, 48201
VA Medical Center, Durham
Durham, North Carolina, 27705
VA New Jersey Health Care System, East Orange
East Orange, New Jersey, 07018
Richard Roudebush VA Medical Center, Indianapolis
Indianapolis, Indiana, 46202-2884
VA Medical Center, Miami
Miami, Florida, 33125
Franklin Delano Roosevelt Campus, VA Hudson Valley HCS
Montrose, New York, 10548
New York Harbor HCS
New York, New York, 10010
VA Palo Alto Health Care System
Palo Alto, California, 94304-1290
VA Maryland HCS, Perry Point Division
Perry Point, Maryland, 21902
VA Medical Center, Philadelphia
Philadelphia, Pennsylvania, 19104
VA Pittsburgh Health Care System
Pittsburgh, Pennsylvania, 15240
VA Medical Center, Tuscaloosa
Tuscaloosa, Alabama, 35404
VA Connecticut Health Care System (West Haven)
West Haven, Connecticut, 06516
About this study
Official title: CSP #451 - The Clinical and Economic Impact of Olanzapine in the Treatment of Schizophrenia
Although currently marketed antipsychotic drugs are useful in the treatment of schizophrenia, efficacy and safety profiles need to be improved. Forty to eighty percent of patients either fail to respond or only partially respond to conventional antipsychotic agents. Secondary symptoms may be unimproved even in patients who respond to treatment. A variety of adverse events occur in patients receiving currently available agents. The severity of these events contributes to the poor compliance that is observed in this patient population. Olanzapine is a novel antipsychotic agent with a reduced incidence of extrapyramidal symptoms. Other side effects are minimal.
Read the detailed description
Primary Hypothesis: To determine if olanzapine is more cost effective than haloperidol for the treatment of schizophrenia.
Secondary Hypothesis: Secondary objectives include evaluation of clinical efficacy, safety, social and vocational functioning, family burden, compliance and satisfaction for olanzapine relative to haloperidol.
Intervention: Olanzapine (5 mg to 20 mg/day), haloperidol (5 mg to 20 mg/day).
Primary Outcomes: Total inpatient hospital care costs are the primary outcome. Other major outcomes are total social costs (cost of VA health care, non-VA services and other specified social costs), efficacy measures (PANNS, BPRS, CGI Severity, and neurocognitive battery scores) and safety measures (adverse events, ECG?s).
Study Abstract: Although currently marketed antipsychotic drugs are useful in the treatment of schizophrenia, efficacy and safety profiles need to be improved. Forty to eighty percent of patients either fail to respond or only partially respond to conventional antipsychotic agents. Secondary symptoms may be unimproved even in patients who respond to treatment. A variety of adverse events occur in patients receiving currently available agents. The severity of these events contributes to the poor compliance that is observed in this patient population. Olanzapine is a novel antipsychotic agent with a reduced incidence of extrapyramidal symptoms. Other side effects are minimal.
Approximately 327 patients with schizophrenia or schizoaffective disorder were randomly assigned to one of two treatment groups. One treatment group was prescribed olanzapine with daily dosage ranging from 5 mg/day to 20 mg/day. The other treatment group was prescribed haloperidol with daily dosage also ranging from 5 mg/day to 20 mg/day. A semi-structured psychosocial case management treatment program is provided for all study patients. Patients were recruited from 18 VA medical centers over a 24-month period and were followed for one year. 18 patients were enrolled at one site that had its research program terminated during the study. Because of questions regarding the circumstances that led to the termination, these 18 patients will not be included in study analyses. The major objective of the study is to determine if olanzapine is more cost effective than haloperidol. Secondary objectives include evaluation of clinical efficacy, safety, social and vocational functioning, family burden, compliance and satisfaction for olanzapine relative to haloperidol.
MANUSCRIPT: Primary manuscript published in JAMA, November 2003.
- Conditions
- Schizoaffective Disorder, Schizophrenia
- Being tested
- Haloperidol, Olanzapine
- Keywords
- Olanzapine, haloperidol, schizophrenia, schisoaffe
- 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.
HaloperidolDrug
OlanzapineDrug
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Olanzapine Receives: Drug: Olanzapine |
| 2 | Active comparator | Haloperidol Receives: Drug: Haloperidol |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jan 2001 (estimated)
- Study startMar 1998
- Primary completionJun 2001
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)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 4
- Masking
- Double blind
- Enrolment
- 600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- US Department of Veterans Affairs
- Sponsor type
- US federal agency
- Collaborators
- Eli Lilly and Company
- Investigators
- Robert A. Rosenheck, AB MD, Study chair, VA Connecticut Health Care System (West Haven)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00007774
- Sponsor's protocol ID
- 451
- Status last verified
- Feb 2009
- First submitted
- 29 Dec 2000
- Last updated
- 4 Feb 2009
- Results posted
- No
- Data monitoring committee
- No
Publications
Perlick DA, Rosenheck RA, Kaczynski R, Bingham S, Collins J. Association of symptomatology and cognitive deficits to functional capacity in schizophrenia. Schizophr Res. 2008 Feb;99(1-3):192-9. doi: 10.1016/j.schres.2007.08.009. Epub 2007 Sep 12.
PubMed 17851042Rosenheck R, Perlick D, Bingham S, Liu-Mares W, Collins J, Warren S, Leslie D, Allan E, Campbell EC, Caroff S, Corwin J, Davis L, Douyon R, Dunn L, Evans D, Frecska E, Grabowski J, Graeber D, Herz L, Kwon K, Lawson W, Mena F, Sheikh J, Smelson D, Smith-Gamble V; Department of Veterans Affairs Cooperative Study Group on the Cost-Effectiveness of Olanzapine. Effectiveness and cost of olanzapine and haloperidol in the treatment of schizophrenia: a randomized controlled trial. JAMA. 2003 Nov 26;290(20):2693-702. doi: 10.1001/jama.290.20.2693.
PubMed 14645311
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CSP #451 - The Clinical and Economic Impact of Olanzapine in the Treatment of Schizophrenia
- ClinicalTrials.gov ID
- NCT00007774
- Acronym / sponsor ID
- 451
- Conditions
- Schizoaffective Disorder, Schizophrenia
- Keywords
- Olanzapine, haloperidol, schizophrenia, schisoaffe
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- US Department of Veterans AffairsUS federal agency
- Collaborators
- Eli Lilly and Company
- Study start
- Mar 1998
- Primary completion
- Jun 2001 (actual)
- First posted
- 1 Jan 2001 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Although currently marketed antipsychotic drugs are useful in the treatment of schizophrenia, efficacy and safety profiles need to be improved. Forty to eighty percent of patients either fail to respond or only partially respond to conventional antipsychotic agents. Secondary symptoms may be unimproved even in patients who respond to treatment. A variety of adverse events occur in patients receiving currently available agents. The severity of these events contributes to the poor compliance that is observed in this patient population. Olanzapine is a novel antipsychotic agent with a reduced incidence of extrapyramidal symptoms. Other side effects are minimal.
Detailed description
Primary Hypothesis: To determine if olanzapine is more cost effective than haloperidol for the treatment of schizophrenia.
Secondary Hypothesis: Secondary objectives include evaluation of clinical efficacy, safety, social and vocational functioning, family burden, compliance and satisfaction for olanzapine relative to haloperidol.
Intervention: Olanzapine (5 mg to 20 mg/day), haloperidol (5 mg to 20 mg/day).
Primary Outcomes: Total inpatient hospital care costs are the primary outcome. Other major outcomes are total social costs (cost of VA health care, non-VA services and other specified social costs), efficacy measures (PANNS, BPRS, CGI Severity, and neurocognitive battery scores) and safety measures (adverse events, ECG?s).
Study Abstract: Although currently marketed antipsychotic drugs are useful in the treatment of schizophrenia, efficacy and safety profiles need to be improved. Forty to eighty percent of patients either fail to respond or only partially respond to conventional antipsychotic agents. Secondary symptoms may be unimproved even in patients who respond to treatment. A variety of adverse events occur in patients receiving currently available agents. The severity of these events contributes to the poor compliance that is observed in this patient population. Olanzapine is a novel antipsychotic agent with a reduced incidence of extrapyramidal symptoms. Other side effects are minimal.
Approximately 327 patients with schizophrenia or schizoaffective disorder were randomly assigned to one of two treatment groups. One treatment group was prescribed olanzapine with daily dosage ranging from 5 mg/day to 20 mg/day. The other treatment group was prescribed haloperidol with daily dosage also ranging from 5 mg/day to 20 mg/day. A semi-structured psychosocial case management treatment program is provided for all study patients. Patients were recruited from 18 VA medical centers over a 24-month period and were followed for one year. 18 patients were enrolled at one site that had its research program terminated during the study. Because of questions regarding the circumstances that led to the termination, these 18 patients will not be included in study analyses. The major objective of the study is to determine if olanzapine is more cost effective than haloperidol. Secondary objectives include evaluation of clinical efficacy, safety, social and vocational functioning, family burden, compliance and satisfaction for olanzapine relative to haloperidol.
MANUSCRIPT: Primary manuscript published in JAMA, November 2003.
Study design
- Masking
- Double blind
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: OlanzapineOlanzapine |
| 2 | Active comparator | Drug: HaloperidolHaloperidol |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Patients with schizophrenia or schizoaffective disorder.
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Haloperidol | Drug | 2 |
| Olanzapine | Drug | 1 |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Feb 2009.
- Results publication: PubMed 17851042Perlick DA, Rosenheck RA, Kaczynski R, Bingham S, Collins J. Association of symptomatology and cognitive deficits to functional capacity in schizophrenia. Schizophr Res. 2008 Feb;99(1-3):192-9. doi: 10.1016/j.schres.2007.08.009. Epub 2007 Sep 12.
- Results publication: PubMed 14645311Rosenheck R, Perlick D, Bingham S, Liu-Mares W, Collins J, Warren S, Leslie D, Allan E, Campbell EC, Caroff S, Corwin J, Davis L, Douyon R, Dunn L, Evans D, Frecska E, Grabowski J, Graeber D, Herz L, Kwon K, Lawson W, Mena F, Sheikh J, Smelson D, Smith-Gamble V; Department of Veterans Affairs Cooperative Study Group on the Cost-Effectiveness of Olanzapine. Effectiveness and cost of olanzapine and haloperidol in the treatment of schizophrenia: a randomized controlled trial. JAMA. 2003 Nov 26;290(20):2693-702. doi: 10.1001/jama.290.20.2693.
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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)
18 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Haloperidol and Olanzapine in people with Schizoaffective Disorder and Schizophrenia, run by US Department of Veterans Affairs at 18 sites in United States.
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 1 inclusion and 0 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 4 Feb 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 18 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00007774, which also lists 2 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 4 Feb 2009.