An Efficacy and Safety Study of 3 Fixed Doses of JNJ-37822681 in Participants With Schizophrenia
A Randomized, Double-Blind, Placebo- and Active-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of 3 Fixed Doses of JNJ-37822681 Administered Twice Daily in Subjects With Schizophrenia
3 other identifiers
interventional
498
10 countries
45
Brief Summary
The purpose of this study is to evaluate the efficacy and safety of 3 fixed doses of JNJ-37822681 compared with placebo (an inactive substance that is compared with a drug to test if the drug has a real effect in a clinical trial) after 6 weeks treatment and olanzapine after 12 weeks treatment in participants with schizophrenia (psychiatric disorder with symptoms of emotional instability, detachment from reality, often with delusions and hallucinations, and withdrawal into the self).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2 schizophrenia
Started Nov 2008
45 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 31, 2008
CompletedFirst Posted
Study publicly available on registry
August 5, 2008
CompletedStudy Start
First participant enrolled
November 1, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2010
CompletedMarch 26, 2014
March 1, 2014
1.3 years
July 31, 2008
March 25, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score at Week 6
The PANSS is a 30-item scale to assess the neuropsychiatric symptoms of schizophrenia. The PANSS provides a total score and scores for 3 subscales, the positive subscale (7 items), the negative subscale (7 items), and the general psychopathology subscale (16 items), each item scored on a scale of 1 (absent) to 7 (extreme). The total score ranges from 30 to 210 and higher score indicates greater severity.
Baseline and Week 6
Secondary Outcomes (11)
Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Subscale Scores at Week 6 and 12
Baseline, Week 6 and 12
Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Marder Subscale Scores at Week 6 and 12
Baseline, Week 6 and 12
Change From Baseline in Clinical Global Impression-Severity (CGI-S) Score at Week 6 and 12
Baseline, Week 6 and 12
Change From Baseline in Subjective Well-Being on Neuroleptics (SWN) Total Score at Week 6 and 12
Baseline, Week 6 and 12
Change From Baseline in Nurses' Observation Scale for Inpatient Evaluation (NOSIE) Total Score at Week 2
Baseline and Week 2
- +6 more secondary outcomes
Study Arms (5)
Placebo First, Then Olanzapine
PLACEBO COMPARATORParticipants will receive 2 matching placebo capsules orally twice daily for 6 consecutive weeks, then 2 matching placebo capsules orally in the morning and olanzapine 10 milligram (mg) capsule along with matching placebo capsule orally in the evening for next 1 week, then 2 matching placebo capsules orally in the morning and olanzapine 10 mg capsule along with olanzapine 5 mg capsule orally in the evening for next 5 weeks.
JNJ-37822681 10 mg
EXPERIMENTALParticipants will receive 1 matching placebo capsule along with JNJ-37822681 10 mg capsule orally twice a day for 12 consecutive weeks.
JNJ-37822681 20 mg
EXPERIMENTALParticipants will receive 1 matching placebo capsule along with JNJ-37822681 20 mg capsule orally twice a day for 12 consecutive weeks.
JNJ-37822681 30 mg
EXPERIMENTALParticipants will receive JNJ-37822681 30 mg (one 10 mg capsule along with JNJ-37822681 20 mg capsule) orally twice a day for 12 consecutive weeks.
Olanzapine
ACTIVE COMPARATORParticipants will receive 2 matching placebo capsules orally in the morning and olanzapine 10 mg capsule along with matching placebo capsule orally in the evening for 1 week, then 2 matching placebo capsules orally in the morning and olanzapine 10 mg capsule along with olanzapine 5 mg capsule orally in the evening for next 11 consecutive weeks.
Interventions
Participants will receive JNJ-37822681 capsule 10 mg orally twice a day for 12 consecutive weeks.
Participants will receive olanzapine 10 mg capsule alone or in combination with olanzapine 5 mg capsule orally for 6 or 12 weeks.
Participants will receive matching placebo capsules orally for 12 weeks.
Eligibility Criteria
You may qualify if:
- Participants must have been diagnosed with schizophrenia according to Diagnostic and Statistical Manual of Mental Disorders, 4th edition (DSM-IV) (295.10, 295.20, 295.30, 295.60, 295.90) at least 1 year prior to screening
- Participants must be experiencing an acute (a quick and severe form of illness in its early stage) exacerbation of less than 6 months duration, with a Positive and Negative Syndrome Scale (PANSS) total score at screening between 70 and 120 inclusive and at baseline of between 60 and 120 inclusive
- Women of child bearing potential must have a negative urine pregnancy test at screening and baseline before receiving the study drug
- Participants must agree to voluntary hospitalization for a minimum of 14 days
- BMI (Body Mass Index) maximum 40 kilogram per meter square (kg/m\^2), inclusive (BMI=weight/height\^2)
You may not qualify if:
- A DSM-IV axis I diagnosis other than schizophrenia
- A DSM-IV diagnosis of substance dependence within 6 months prior to screening evaluation
- Any clinically relevant medical condition that could potentially alter the absorption (the way a drug or other substance enters the body), metabolism, or excretion (the way that substances leave the body) of the study medication, such as Crohn's disease (serious inflammation of any part of the gastrointestinal tract), liver disease, or renal (pertaining to the kidneys) disease
- Relevant history of any significant and/or unstable cardiovascular (pertaining to the heart and blood vessels), respiratory, neurological (including seizures) or significant cerebrovascular (pertaining to brain and blood vessels), renal, hepatic, endocrine (pertaining to the glands that make hormones), or immunologic diseases
- History of neuroleptic malignant syndrome (high fever, rigid muscles, shaking, confusion, sweating more than usual, increased heart rate or blood pressure, or muscle pain or weakness)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (45)
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Burgas, Bulgaria
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Pazardzhik, Bulgaria
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Radnevo, Bulgaria
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Rousse, Bulgaria
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Sofia, Bulgaria
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Tallinn, Estonia
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Tartu, Estonia
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Kaunas, Lithuania
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Vilnius, Lithuania
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Johor Bahru, Malaysia
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Kuala Lumpur, Malaysia
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Kuching, Malaysia
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Arad, Romania
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Brasov, Romania
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Bucharest, Romania
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Jebel, Romania
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Oradea, Romania
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Sibiu, Romania
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Tg Mures, Romania
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Ekaterinburg Na, Russia
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Moscow, Russia
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Moscow Russia, Russia
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N Novgorod Na, Russia
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Saint Petersburg, Russia
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Samara, Russia
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Saratov, Russia
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Tomsk Na, Russia
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Yaroslavl, Russia
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Cape Town, South Africa
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Centurion Gauteng, South Africa
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Pretoria, South Africa
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Gwangju, South Korea
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Gyeongsangnam-Do, South Korea
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Incheon, South Korea
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Seoul, South Korea
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Hualien City, Taiwan
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Kaohsiung City, Taiwan
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Taipei, Taiwan
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Dnipropetrovsk, Ukraine
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Donetsk, Ukraine
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Kharkiv, Ukraine
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Kherson, Ukraine
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Kiev, Ukraine
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Odesa, Ukraine
Unknown Facility
Simferopol, Ukraine
Related Publications (1)
Anghelescu IG, Janssens L, Kent J, de Boer P, Tritsmans L, Daly EJ, van Nueten L, Schmidt ME. Does early improvement predict response to the fast-dissociating D(2) receptor antagonist JNJ-37822681 in patients with acute schizophrenia? Eur Neuropsychopharmacol. 2013 Sep;23(9):1043-50. doi: 10.1016/j.euroneuro.2012.08.017. Epub 2012 Sep 18.
PMID: 22995972DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Johnson & Johnson Pharmaceutical Research & Development, L.L.C Clinical Trial
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 31, 2008
First Posted
August 5, 2008
Study Start
November 1, 2008
Primary Completion
February 1, 2010
Study Completion
February 1, 2010
Last Updated
March 26, 2014
Record last verified: 2014-03