SchizophreniaPhase 4NCT00337662

Efficacy Study of Early Onset of Antipsychotic Drug Action in Schizophrenia

A Phase 4 study testing olanzapine and risperidone in people with Schizophrenia and Schizoaffective Disorder, run by Eli Lilly and Company at 34 sites in 3 countries.

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

The current study has been designed to address the significance of early onset of response prospectively in patients treated with an atypical antipsychotic. Read more about this study

Who is it for?: Ages 18 to 65 years
Conditions the study is for: Schizophrenia, Schizoaffective Disorder, Schizophreniform Disorder
What is being tested?: olanzapine and risperidone
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 628 participants
Where: 34 sitesin 3 countries
Study dates: May 2006to Dec 2007
Phase: Phase 4
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 to 65 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Patients must demonstrate acute psychopathologic severity criteria and be at least moderately ill.
Patients must have experienced an exacerbation of their illness within the previous 2 weeks.
Patients in whom a switch to another antipsychotic medication is acutely indicated.

Who cannot join

Patients who are deemed nonresponsive to risperidone or olanzapine.
Patients who have been hospitalized for greater than 2 weeks immediately prior to Visit 1.
Patients having received olanzapine or risperidone in the past 30 days.
Treatment with clozapine within 1 year prior to Visit 1.
Diagnosis of substance-induced psychosis by Diagnostic and Statistical Manual of Mental Disorders Fourth Edition (DSM-IV) criteria within 7 days of Visit 1 (or at any time during the study), or confirmed on clinical grounds within 72 hours subsequent to Visit 1 (or at any time during the study).
A diagnosis of Parkinson's disease, dementia-related psychosis, or related disorders.

Trial locations and contacts

34 sites in 3 countries.

Country

City, postcode or hospital

34 sites in 3 countries

United States31 sites

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Arlington, Virginia, 22201
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Austin, Texas, 78754
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Boston, Massachusetts, 02118
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Cedarhurst, New York, 11516
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Chicago, Illinois, 60640
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Clementon, New Jersey, 08021
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Escondido, California, 92025
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Fort Lauderdale, Florida, 33319
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Garden Grove, California, 92845
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Glendale, California, 91206
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Hialeah, Florida, 33016
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Jackson, Mississippi, 39216
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Kansas City, Missouri, 64108
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Kirkland, Washington, 98033
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Lake Charles, Louisiana, 70601
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Little Rock, Arkansas, 72201
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Memphis, Tennessee, 38117
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National City, California, 91950
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Olean, New York, 14760
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Omaha, Nebraska, 68133
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Orange, California, 92868
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Paducah, Kentucky, 42003
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Philadelphia, Pennsylvania, 19131
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Portsmouth, Virginia, 23703
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Rapid City, South Dakota, 57701
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Richmond, Virginia, 23298
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San Diego, California, 92123
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Santa Ana, California, 92701
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Staten Island, New York, 10312
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Toledo, Ohio, 43623
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Washington D.C., District of Columbia, 20016

Other trials in United States

Russia2 sites

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Khot'kovo, 127025
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Moscow, 115522

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Argentina1 site

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Buenos Aires, C1062ABF

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About this study

Official title: Predicting Response to Risperidone Treatment Through Identification of Early-onset of Antipsychotic Drug Action in Schizophrenia.

The current study has been designed to address the significance of early onset of response prospectively in patients treated with an atypical antipsychotic.

Conditions: Schizophrenia, Schizoaffective Disorder, Schizophreniform Disorder
Being tested: olanzapine, risperidone
Medical subject headings: Schizophrenia, Psychotic Disorders

What participants receive

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

olanzapineDrug
Also called LY170053, Zyprexa
10-20 milligrams (mg), oral, daily, 10 weeks.
risperidoneDrug
2-6 mg, oral, daily, for 10 weeks.
risperidoneDrug
2-6 mg, oral, daily, 10 weeks

Study groups in NCT00337662
Study group	Role	What they receive
1	Experimental	Olanzapine for Not Early Onset response (NEO) patients Receives: Drug: olanzapine
2	Active comparator	Risperidone for Not Early Onset response (NEO) patients Receives: Drug: risperidone
3	Active comparator	Risperidone for Early Onset response (EO) patients Receives: Drug: risperidone

What is being measured

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

Changes From Study Period II Baseline (Week 0) to Weeks 3, 4, 6, 8, and 12 in Positive and Negative Syndrome Scale (PANSS) Total Score in Early Onset Response and Not Early Onset Response-Risperidone Patients
Assesses positive symptoms, negative symptoms, and general psychopathology specifically associated with schizophrenia. Scale consists of 30 items. Each item is rated on a scale from 1 (symptom not present) to 7 (symptoms extremely severe). Sum of 30 items is PANSS total score and ranges from 30 to 210. Change = time point - single-blind baseline (Week 0).
Measured: Weeks 0, 3, 4, 6, 8, 12

Secondary outcomes (17)

Changes From Study Period III Baseline (Week 2) to Weeks 3, 4, 6, 8, and 12 in Positive and Negative Syndrome Scale Total Score in Not Early Onset Response-Risperidone and Not Early Onset Response-Olanzapine Patients
Assesses positive symptoms, negative symptoms, and general psychopathology specifically associated with schizophrenia. Scale consists of 30 items. Each item is rated on a scale from 1 (symptom not present) to 7 (symptoms extremely severe). Sum of 30 items is PANSS total score and ranges from 30 to 210. Change = time point - double-blind baseline (Week 2).
Measured: Weeks 2, 3, 4, 6, 8, 12
The Number of Participants in the Early Onset (EO) and Not Early Onset-Risperidone (NEO-RIS) Groups Who Show a 20% or Greater Reduction in Positive and Negative Syndrome Scale (PANSS) Total Score
The number of participants who experienced a 20% or greater reduction in their PANSS Total score during the 12 weeks they were on risperidone.
Measured: Week 0 to Week 12
The Number of Participants in the Not Early Onset-Risperidone (NEO-RIS) and Not Early Onset-Olanzapine (NEO-OLZ) Groups Who Show a 20% or Greater Reduction in Positive and Negative Syndrome Scale (PANSS) Total Score
The number of not early onset participants who experienced a 20% or greater reduction in PANSS Total Score at any time during the 12 weeks of combined Study Period II and Study Period III.
Measured: Week 0 to Week 12
Number of Participants in the Early Onset and Not Early Onset-Risperidone Groups Who Show a 50% or Greater Reduction in Positive and Negative Syndrome Scale (PANSS) Total Score From Baseline or Meet 'a Priori' Specified Criteria for Remission
'a priori' specified criteria for remission defined as a score of 3 (mild), 2 (minimal), or 1 (absent) on all of the following 8 PANSS items: delusions, conceptual disorganization, hallucinatory behavior, unusual thought content, mannerisms and posturing, blunted effect, passive/apathetic withdrawal, lack of spontaneity and flow of conversation.
Measured: Week 0 to Week 12
Number of Participants in the Not Early Onset-Risperidone and Not Early Onset-Olanzapine Groups Who Show a 50% or Greater Reduction in Positive and Negative Syndrome Scale Total Score From Baseline or Meet 'a Priori' Specified Criteria for Remission
'a priori' specified criteria for remission defined as a score of 3 (mild), 2 (minimal), or 1 (absent) on all of the following 8 PANSS items: delusions, conceptual disorganization, hallucinatory behavior, unusual thought content, mannerisms and posturing, blunted effect, passive/apathetic withdrawal, lack of spontaneity and flow of conversation.
Measured: Week 2 to Week 12
Number of Participants With Psychiatric Hospitalizations in the Early Onset and Not Early Onset-Risperidone Groups
Psychiatric Hospitalizations were measured by the Modified Schizophrenia Care and Assessment Program Health Questionnaire (SCAP-HQ) from which it could be determined the number of patients with a psychiatric episode that required an overnight stay in a hospital.
Measured: Week 2 to Week 12
Vital Signs - Mean Change From Baseline to 10 Week Endpoint in Body Mass Index
Body mass index is an estimate of body fat based on body weight divided by height squared. Change = Endpoint minus baseline.
Measured: Week 2 to Week 12
Number of Participants With Treatment-Emergent Abnormal Fasting Laboratory Analytes Reported in >=2% of All Participants
Number of participants who experienced abnormal fasting laboratory values at any time during Study Period III. Laboratory reference ranges are dependent on the patient's gender, origin, and age.
Measured: Week 2 to Week 12
Mean Change From Baseline to 10 Week Endpoint in Extrapyramidal Symptoms as Measured by the Modified Simpson-Angus Scale
Measures neuroleptic-induced parkinsonism. Total score consists of the sum of 10 items: 7 items (items 1, 3, 4, 7, 8, 9, 10) rated on a 4-point severity scale where 0=normal and 4=extreme, and 3 items (items 2, 5, 6) rated on a 2-point severity scale where 0=normal and 2=definitely abnormal/present. The total score ranges from 0 to 34.
Measured: Week 2 to Week 12
Mean Change From Baseline to 10 Week Endpoint in Extrapyramidal Symptoms as Measured by the Barnes Akathisia Rating Scale - Total Score
Evaluates akathisia associated with use of antipsychotic medications, includes objective and subjective component plus global impression rating for overall disorder. Components rated on scale of 0 to 3 for objective and subjective items and 0 to 5 for global clinical assessment, for total score of 0 (absence of akathisia) to 11 (severe akathisia).
Measured: Week 2 to Week 12
Mean Change From Baseline to 10 Week Endpoint in Extrapyramidal Symptoms as Measured by the Abnormal Involuntary Movement Scale (AIMS)- Non-Global Total Score
A 12-item instrument assesses observed abnormal movements in different parts of body. Ten items are scored in a 5-point scale (0 = none/normal, 4 = severe) which evaluates abnormal movements in three main anatomic areas (orofacial area, extremities, and trunk). Two items are yes/no questions regarding dentures. Total scores range from 0 to 42.
Measured: Week 2 to Week 12
Vital Signs - Mean Change From Baseline to 10 Week Endpoint in Sitting Pulse Rate
Changes from Study Period III baseline to endpoint in sitting pulse rate. Change = Endpoint minus baseline.
Measured: Week 2 and Week 12
Vital Signs - Change From Baseline to 10 Week Endpoint in Standing Diastolic Blood Pressure
Change from Study Period III baseline to endpoint in standing blood pressure. Change = Endpoint minus baseline.
Measured: Week 2 and Week 12
Vital Signs - Change From Baseline to 10 Week Endpoint in Standing Mean Arterial Pressure
Change from Study Period III baseline to endpoint in standing mean arterial pressure. Change = Endpoint minus baseline.
Measured: Week 2 and Week 12
Vital Signs - Mean Change From Baseline to 10 Week Endpoint in Standing Pulse Rate
Change from Study Period III baseline to endpoint in standing pulse rate. Change = Endpoint minus baseline.
Measured: Week 2 and Week 12
Vital Signs - Mean Change From Baseline to 10 Week Endpoint in Standing Systolic Blood Pressure
Change from Study Period III baseline to endpoint in standing systolic blood pressure. Change = Endpoint minus baseline.
Measured: Week 2 and Week 12
Vital Signs - Mean Change From Baseline to 10 Week Endpoint in Body Weight
Change from Study Period III baseline to endpoint in body weight. Change = Endpoint minus baseline.
Measured: Week 2 and Week 12

Timeline

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

May 2006Dec 2007

First posted16 Jun 2006 (estimated)
Study startMay 2006
Primary completionDec 2007
Study completionDec 2007

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 (4)Papers the sponsor has linked to this study.
Other trials for SchizophreniaStudies of the same condition, open and under way.
More trials run by Eli Lilly and CompanyThe sponsor's other registered studies.
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
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 628 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00337662
Sponsor's protocol ID: 10769
Other IDs: F1D-US-HGMN
Status last verified: Feb 2010
First submitted: 14 Jun 2006
Last updated: 17 Feb 2010
Results posted: Yes, on ClinicalTrials.gov

Publications

Chen L, Phillips G, Johnston J, Kinon BJ, Ascher-Svanum H, Kollack-Walker S, Succop P, Naber D. The relationship, structure and profiles of schizophrenia measurements: a post-hoc analysis of the baseline measures from a randomized clinical trial. BMC Psychiatry. 2011 Dec 28;11:203. doi: 10.1186/1471-244X-11-203.
PubMed 22204569
Fijal BA, Stauffer VL, Kinon BJ, Conley RR, Hoffmann VP, Witte MM, Zhao F, Houston JP. Analysis of gene variants previously associated with iloperidone response in patients with schizophrenia who are treated with risperidone. J Clin Psychiatry. 2012 Mar;73(3):367-71. doi: 10.4088/JCP.10m06507. Epub 2011 Jul 12.
PubMed 21813073
Ascher-Svanum H, Nyhuis AW, Stauffer V, Kinon BJ, Faries DE, Phillips GA, Schuh K, Awad AG, Keefe R, Naber D. Reasons for discontinuation and continuation of antipsychotics in the treatment of schizophrenia from patient and clinician perspectives. Curr Med Res Opin. 2010 Oct;26(10):2403-10. doi: 10.1185/03007995.2010.515900.
PubMed 20812791
Kinon BJ, Chen L, Ascher-Svanum H, Stauffer VL, Kollack-Walker S, Zhou W, Kapur S, Kane JM. Early response to antipsychotic drug therapy as a clinical marker of subsequent response in the treatment of schizophrenia. Neuropsychopharmacology. 2010 Jan;35(2):581-90. doi: 10.1038/npp.2009.164.
PubMed 19890258

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 17 Feb 2010. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Predicting Response to Risperidone Treatment Through Identification of Early-onset of Antipsychotic Drug Action in Schizophrenia.
ClinicalTrials.gov ID: NCT00337662
Acronym / sponsor ID: 10769
Conditions: Schizophrenia, Schizoaffective Disorder, Schizophreniform Disorder
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 628 participants (actual)
Lead sponsor: Eli Lilly and CompanyIndustry (pharma, biotech, devices)
Study start: May 2006
Primary completion: Dec 2007 (actual)
Study completion: Dec 2007 (actual)
First posted: 16 Jun 2006 (estimated)
Results: Posted 4 Aug 2009

Clinical summary

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

The current study has been designed to address the significance of early onset of response prospectively in patients treated with an atypical antipsychotic.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 3

Arm	Type	Receives
1	Experimental	Drug: olanzapineOlanzapine for Not Early Onset response (NEO) patients
2	Active comparator	Drug: risperidoneRisperidone for Not Early Onset response (NEO) patients
3	Active comparator	Drug: risperidoneRisperidone for Early Onset response (EO) patients

Who may qualify

Ages: 18 to 65 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

Patients must demonstrate acute psychopathologic severity criteria and be at least moderately ill.
Patients must have experienced an exacerbation of their illness within the previous 2 weeks.
Patients in whom a switch to another antipsychotic medication is acutely indicated.

Key exclusion criteria (6 listed)

Patients who are deemed nonresponsive to risperidone or olanzapine.
Patients who have been hospitalized for greater than 2 weeks immediately prior to Visit 1.
Patients having received olanzapine or risperidone in the past 30 days.
Treatment with clozapine within 1 year prior to Visit 1.
Diagnosis of substance-induced psychosis by Diagnostic and Statistical Manual of Mental Disorders Fourth Edition (DSM-IV) criteria within 7 days of Visit 1 (or at any time during the study), or confirmed on clinical grounds within 72 hours subsequent to Visit 1 (or at any time during the study).

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
olanzapineAlso: LY170053, Zyprexa10-20 milligrams (mg), oral, daily, 10 weeks.	Drug	1
risperidone2-6 mg, oral, daily, for 10 weeks.	Drug	2
risperidone2-6 mg, oral, daily, 10 weeks	Drug	3

Primary outcome

Changes From Study Period II Baseline (Week 0) to Weeks 3, 4, 6, 8, and 12 in Positive and Negative Syndrome Scale (PANSS) Total Score in Early Onset Response and Not Early Onset Response-Risperidone Patients
Time frame: Weeks 0, 3, 4, 6, 8, 12
Assesses positive symptoms, negative symptoms, and general psychopathology specifically associated with schizophrenia. Scale consists of 30 items. Each item is rated on a scale from 1 (symptom not present) to 7 (symptoms extremely severe). Sum of 30 items is PANSS total score and ranges from 30 to 210. Change = time point - single-blind baseline (Week 0).

17 secondary outcomes

Changes From Study Period III Baseline (Week 2) to Weeks 3, 4, 6, 8, and 12 in Positive and Negative Syndrome Scale Total Score in Not Early Onset Response-Risperidone and Not Early Onset Response-Olanzapine Patients
Time frame: Weeks 2, 3, 4, 6, 8, 12
The Number of Participants in the Early Onset (EO) and Not Early Onset-Risperidone (NEO-RIS) Groups Who Show a 20% or Greater Reduction in Positive and Negative Syndrome Scale (PANSS) Total Score
Time frame: Week 0 to Week 12
The Number of Participants in the Not Early Onset-Risperidone (NEO-RIS) and Not Early Onset-Olanzapine (NEO-OLZ) Groups Who Show a 20% or Greater Reduction in Positive and Negative Syndrome Scale (PANSS) Total Score
Time frame: Week 0 to Week 12
Number of Participants in the Early Onset and Not Early Onset-Risperidone Groups Who Show a 50% or Greater Reduction in Positive and Negative Syndrome Scale (PANSS) Total Score From Baseline or Meet 'a Priori' Specified Criteria for Remission
Time frame: Week 0 to Week 12
Number of Participants in the Not Early Onset-Risperidone and Not Early Onset-Olanzapine Groups Who Show a 50% or Greater Reduction in Positive and Negative Syndrome Scale Total Score From Baseline or Meet 'a Priori' Specified Criteria for Remission
Time frame: Week 2 to Week 12
Number of Participants With Psychiatric Hospitalizations in the Early Onset and Not Early Onset-Risperidone Groups
Time frame: Week 2 to Week 12
Vital Signs - Mean Change From Baseline to 10 Week Endpoint in Body Mass Index
Time frame: Week 2 to Week 12
Number of Participants With Treatment-Emergent Abnormal Fasting Laboratory Analytes Reported in >=2% of All Participants
Time frame: Week 2 to Week 12
Mean Change From Baseline to 10 Week Endpoint in Extrapyramidal Symptoms as Measured by the Modified Simpson-Angus Scale
Time frame: Week 2 to Week 12
Mean Change From Baseline to 10 Week Endpoint in Extrapyramidal Symptoms as Measured by the Barnes Akathisia Rating Scale - Total Score
Time frame: Week 2 to Week 12
Mean Change From Baseline to 10 Week Endpoint in Extrapyramidal Symptoms as Measured by the Abnormal Involuntary Movement Scale (AIMS)- Non-Global Total Score
Time frame: Week 2 to Week 12
Vital Signs - Mean Change From Baseline to 10 Week Endpoint in Sitting Pulse Rate
Time frame: Week 2 and Week 12
Vital Signs - Change From Baseline to 10 Week Endpoint in Standing Diastolic Blood Pressure
Time frame: Week 2 and Week 12
Vital Signs - Change From Baseline to 10 Week Endpoint in Standing Mean Arterial Pressure
Time frame: Week 2 and Week 12
Vital Signs - Mean Change From Baseline to 10 Week Endpoint in Standing Pulse Rate
Time frame: Week 2 and Week 12
Vital Signs - Mean Change From Baseline to 10 Week Endpoint in Standing Systolic Blood Pressure
Time frame: Week 2 and Week 12
Vital Signs - Mean Change From Baseline to 10 Week Endpoint in Body Weight
Time frame: Week 2 and Week 12

Results and safety

Results posted to the registry on 4 Aug 2009, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
NEO-OLZ	0	0
NEO-RIS	0	0
EO-RIS	0	0
Risperiodone Open-Label Lead-In	628	522

Primary outcome: Changes From Study Period II Baseline (Week 0) to Weeks 3, 4, 6, 8, and 12 in Positive and Negative Syndrome Scale (PANSS) Total Score in Early Onset Response and Not Early Onset Response-Risperidone Patients

Time frame: Weeks 0, 3, 4, 6, 8, 12. Least squares mean (Standard Error). Unit: units on a scale

Measure	NEO-RIS n = 189	EO-RIS n = 138
Change from Week 0 to Week 3	-11.90 (1.15)	-30.80 (1.23)
Change from Week 0 to Week 4	-14.81 (1.16)	-32.53 (1.24)
Change from Week 0 to Week 6	-16.23 (1.26)	-32.90 (1.36)
Change from Week 0 to Week 8	-18.10 (1.31)	-34.10 (1.43)
Change from Week 0 to Week 12	-18.62 (1.38)	-35.09 (1.50)

NEO-RIS vs EO-RIS: p <0.001, Mixed Effects Model Repeated Measures

Population analysed: Intention to treat for patients with both baseline and any postbaseline assessment

17 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 2% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
NEO-OLZ	19 of 186 (10.2%)	97 of ?	Not reported
NEO-RIS	12 of 192 (6.3%)	100 of ?	Not reported
EO-RIS	14 of 144 (9.7%)	83 of ?	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2010.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 22204569Chen L, Phillips G, Johnston J, Kinon BJ, Ascher-Svanum H, Kollack-Walker S, Succop P, Naber D. The relationship, structure and profiles of schizophrenia measurements: a post-hoc analysis of the baseline measures from a randomized clinical trial. BMC Psychiatry. 2011 Dec 28;11:203. doi: 10.1186/1471-244X-11-203.
Derived from this study: PubMed 21813073Fijal BA, Stauffer VL, Kinon BJ, Conley RR, Hoffmann VP, Witte MM, Zhao F, Houston JP. Analysis of gene variants previously associated with iloperidone response in patients with schizophrenia who are treated with risperidone. J Clin Psychiatry. 2012 Mar;73(3):367-71. doi: 10.4088/JCP.10m06507. Epub 2011 Jul 12.
Derived from this study: PubMed 20812791Ascher-Svanum H, Nyhuis AW, Stauffer V, Kinon BJ, Faries DE, Phillips GA, Schuh K, Awad AG, Keefe R, Naber D. Reasons for discontinuation and continuation of antipsychotics in the treatment of schizophrenia from patient and clinician perspectives. Curr Med Res Opin. 2010 Oct;26(10):2403-10. doi: 10.1185/03007995.2010.515900.
Derived from this study: PubMed 19890258Kinon BJ, Chen L, Ascher-Svanum H, Stauffer VL, Kollack-Walker S, Zhou W, Kapur S, Kane JM. Early response to antipsychotic drug therapy as a clinical marker of subsequent response in the treatment of schizophrenia. Neuropsychopharmacology. 2010 Jan;35(2):581-90. doi: 10.1038/npp.2009.164.
Lilly Clinical Trial RegistryLink provided by the sponsor.

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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.

Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST) study director

Eli Lilly and Company

34 sites in 3 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing olanzapine and risperidone in people with Schizophrenia and Schizoaffective Disorder, run by Eli Lilly and Company at 34 sites in 3 countries.

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 3 inclusion and 6 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 17 Feb 2010. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 34 sites in United States, Russia, Argentina. 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?

Yes. Results are posted in the registry (first posted 4 Aug 2009). 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?

Changes From Study Period II Baseline (Week 0) to Weeks 3, 4, 6, 8, and 12 in Positive and Negative Syndrome Scale (PANSS) Total Score in Early Onset Response and Not Early Onset Response-Risperidone Patients (time frame: Weeks 0, 3, 4, 6, 8, 12). 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 NCT00337662, which also lists 4 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 17 Feb 2010.