SchizophreniaPhase 2NCT00728195
An Efficacy and Safety Study of 3 Fixed Doses of JNJ-37822681 in Participants With Schizophrenia
A Phase 2 study testing JNJ-37822681 and Olanzapine in people with Schizophrenia, run by Johnson & Johnson Pharmaceutical Research & Development, L.L.C. at 45 sites in 10 countries.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Schizophrenia
- What is being tested?
- JNJ-37822681 and Olanzapine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 498 participants
- Where
- 45 sitesin 10 countries
- Study dates
- Nov 2008to Feb 2010
- Phase
- Phase 2
- 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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)
Trial locations and contacts
45 sites in 10 countries.
45 sites in 10 countries
Russia9 sites
Study site
Ekaterinburg Na
Study site
Moscow
Study site
Moscow Russia
Study site
N Novgorod Na
Study site
Saint Petersburg
Study site
Samara
Study site
Saratov
Study site
Tomsk Na
Study site
Yaroslavl
Romania7 sites
Study site
Arad
Study site
Brasov
Study site
Bucharest
Study site
Jebel
Study site
Oradea
Study site
Sibiu
Study site
Tg Mures
Ukraine7 sites
Study site
Dnipropetrovsk
Study site
Donetsk
Study site
Kharkiv
Study site
Kherson
Study site
Kiev
Study site
Odesa
Study site
Simferopol
Bulgaria5 sites
Study site
Burgas
Study site
Pazardzhik
Study site
Radnevo
Study site
Rousse
Study site
Sofia
South Korea4 sites
Study site
Gwangju
Study site
Gyeongsangnam-Do
Study site
Incheon
Study site
Seoul
Malaysia3 sites
Study site
Johor Bahru
Study site
Kuala Lumpur
Study site
Kuching
South Africa3 sites
Study site
Cape Town
Study site
Centurion Gauteng
Study site
Pretoria
Taiwan3 sites
Study site
Hualien City
Study site
Kaohsiung City
Study site
Taipei
About this study
Official title: 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
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).
Read the detailed description
This is a multicenter (when more than one hospital or medical school team work on a medical research study), double-blind (neither the participant nor the physician know the study medication drug name), randomized (study drug assigned by chance), placebo- and active-controlled, parallel-group (a clinical trial comparing the response in two or more groups of participants receiving different treatments), dose-response study in participants with schizophrenia. The total study duration will not exceed 16 weeks for each participant and will include following visits: screening, baseline, Week 1, 2, 3, 4, 5, 6, 7, 8, 9, 11 and 13 (end of treatment or early withdrawal), and a post-study safety visit (1 week after final dose of study drug). All participants will be hospitalized during the first 2 weeks of treatment for detailed follow-up of safety and disease status. Following a screening period, participants will be randomly assigned to one of 5 treatment groups to receive oral doses of JNJ-37822681 (10, 20 or 30 milligram [mg] twice a day) for 12 weeks, olanzapine 15 mg daily for 12 weeks, or placebo for 6 weeks followed by olanzapine 15 mg daily for the remaining 6 weeks. Olanzapine will be initiated at 10 mg daily for 1 week and then increased to 15 mg daily for the remainder of the treatment period. Efficacy will primarily be evaluated by Positive And Negative Syndrome Scale (PANSS). Participants' safety will also be monitored at each visit.
- Conditions
- Schizophrenia
- Being tested
- JNJ-37822681, Olanzapine, Placebo
- Keywords
- Schizophrenia, Central Nervous System, JNJ-37822681
- Medical subject headings
- Schizophrenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
JNJ-37822681Drug
Participants will receive JNJ-37822681 capsule 10 mg orally twice a day for 12 consecutive weeks.
JNJ-37822681Drug
Participants will receive JNJ-37822681 capsule 20 mg orally twice a day for 12 consecutive weeks.
JNJ-37822681Drug
Participants will receive JNJ-37822681 capsule 30 mg orally twice a day for 12 consecutive weeks.
OlanzapineDrug
Participants will receive olanzapine 10 mg capsule alone or in combination with olanzapine 5 mg capsule orally for 6 or 12 weeks.
PlaceboDrug
Participants will receive matching placebo capsules orally for 12 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Placebo First, Then Olanzapine | Placebo comparator | Participants 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. Receives: Drug: Olanzapine; Drug: Placebo |
| JNJ-37822681 10 mg | Experimental | Participants will receive 1 matching placebo capsule along with JNJ-37822681 10 mg capsule orally twice a day for 12 consecutive weeks. Receives: Drug: JNJ-37822681; Drug: Placebo |
| JNJ-37822681 20 mg | Experimental | Participants will receive 1 matching placebo capsule along with JNJ-37822681 20 mg capsule orally twice a day for 12 consecutive weeks. Receives: Drug: JNJ-37822681; Drug: Placebo |
| JNJ-37822681 30 mg | Experimental | Participants 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. Receives: Drug: JNJ-37822681 |
| Olanzapine | Active comparator | Participants 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. Receives: Drug: Olanzapine; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline and Week 6
Secondary outcomes (11)
Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Subscale Scores at Week 6 and 12
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). Positive subscale score ranges from 7 (absent) to 49 (extreme psychopathology), negative subscale score ranges from 7 (absent) to 49 (extreme psychopathology) and general psychopathology subscale score ranges from 16 (absent) to 112 (extreme psychopathology).
Measured: Baseline, Week 6 and 12
Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Marder Subscale Scores at Week 6 and 12
The PANSS is a 30-item scale to assess the neuropsychiatric symptoms of schizophrenia. The symptoms are rated on a 7-point scale from 1 (absent) to 7 (extreme psychopathology). Positive symptoms subscale consists of 8 items with total score range of 8-56; negative symptoms subscale and disorganized thoughts subscale, each consists of 7 items with total score range of 7-49 and uncontrolled hostility/excitement (UHE) subscale and anxiety/depression subscale, each consists of 4 items with total score range of 4-28. Higher score indicates greater severity.
Measured: Baseline, Week 6 and 12
Change From Baseline in Clinical Global Impression-Severity (CGI-S) Score at Week 6 and 12
The CGI-S rating scale assesses the severity of a participant's overall clinical condition on a 7-point scale ranging from 1 (not ill) to 7 (extremely severe).
Measured: Baseline, Week 6 and 12
Change From Baseline in Subjective Well-Being on Neuroleptics (SWN) Total Score at Week 6 and 12
The SWN is a participant self rated scale to evaluate the participant's feelings during the past 7 days on a form with 20 statements, subsequently divided into 5 subscales: mental-functioning, self-control, emotional regulation, physical functioning and social integration. Each item is scored between 1 (not at all) and 6 (very much). Total score ranges from 20-120 with higher scores indicating higher subjective well-being.
Measured: Baseline, Week 6 and 12
Change From Baseline in Nurses' Observation Scale for Inpatient Evaluation (NOSIE) Total Score at Week 2
The NOSIE comprises 30 items which form 6 scales: social competence, social interest, personal neatness, irritability, manifest psychosis and retardation and is completed by a suitably trained and experienced member of the nursing staff. Each item is scored from 0 (never) to 4 (always). It was assessed only at 2 weeks when the participants were hospitalized. Total score ranges from 0 to 120, with lower score indicating better results.
Measured: Baseline and Week 2
Change From Baseline in Plasma Markers Level for Lipid and Glucose Metabolism at Week 6 and 12
Change from baseline in the level of plasma (liquid part of blood where cells float) markers for lipid (fat) and glucose (type of sugar found in the blood) metabolism (process of breaking down substances in the cells to obtain energy) is calculated. Markers for lipid metabolism include fasting total cholesterol, high-density lipoproteins (HDL), low-density lipoproteins (LDL), very low-density lipoproteins (VLDL), triglycerides and free fatty acids. Fasting glucose level is used as marker for glucose metabolism.
Measured: Baseline, Week 6 and 12
Change From Baseline in Free Fatty Acids Level at Week 6 and 12
Change from baseline in the level of free fatty acids (plasma marker for lipid metabolism) is calculated.
Measured: Baseline, Week 6 and 12
Change From Baseline in Insulin Level at Week 6 and 12
Change from baseline in the level of insulin (the hormone that controls blood sugar levels) as plasma marker for glucose metabolism is calculated.
Measured: Baseline, Week 6 and 12
Change From Baseline in Glycosylated Hemoglobin (HbA1c) Level at Week 6 and 12
Change from baseline in the level of glycosylated hemoglobin (substance that carries oxygen and gives blood its red color) as plasma marker for glucose metabolism is calculated.
Measured: Baseline, Week 6 and 12
Change From Baseline in Body Mass Index (BMI) at Week 6 and 12
The BMI is calculated by dividing the weight (in kilogram) by square of height (in meters).
Measured: Baseline, Week 6 and 12
Change From Baseline in Body Weight at Week 6 and 12
Measured: Baseline, Week 6 and 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2008 (estimated)
- Study startNov 2008
- Primary completionFeb 2010
- Study completionFeb 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for SchizophreniaStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 498 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Johnson & Johnson Pharmaceutical Research & Development, L.L.C Clinical Trial, Study director, Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00728195
- Sponsor's protocol ID
- CR014737
- Other IDs
- 37822681SCH2002, 2007-007083-22
- Status last verified
- Mar 2014
- First submitted
- 31 Jul 2008
- Last updated
- 26 Mar 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 22995972
Study at a glance
From the registry record, last updated by the sponsor on 26 Mar 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT00728195
- Acronym / sponsor ID
- CR014737
- Conditions
- Schizophrenia
- Keywords
- Schizophrenia, Central Nervous System, JNJ-37822681
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 498 participants (actual)
- Lead sponsor
- Johnson & Johnson Pharmaceutical Research & Development, L.L.C.Industry (pharma, biotech, devices)
- Study start
- Nov 2008
- Primary completion
- Feb 2010 (actual)
- Study completion
- Feb 2010 (actual)
- First posted
- 5 Aug 2008 (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.
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).
Detailed description
This is a multicenter (when more than one hospital or medical school team work on a medical research study), double-blind (neither the participant nor the physician know the study medication drug name), randomized (study drug assigned by chance), placebo- and active-controlled, parallel-group (a clinical trial comparing the response in two or more groups of participants receiving different treatments), dose-response study in participants with schizophrenia. The total study duration will not exceed 16 weeks for each participant and will include following visits: screening, baseline, Week 1, 2, 3, 4, 5, 6, 7, 8, 9, 11 and 13 (end of treatment or early withdrawal), and a post-study safety visit (1 week after final dose of study drug). All participants will be hospitalized during the first 2 weeks of treatment for detailed follow-up of safety and disease status. Following a screening period, participants will be randomly assigned to one of 5 treatment groups to receive oral doses of JNJ-37822681 (10, 20 or 30 milligram [mg] twice a day) for 12 weeks, olanzapine 15 mg daily for 12 weeks, or placebo for 6 weeks followed by olanzapine 15 mg daily for the remaining 6 weeks. Olanzapine will be initiated at 10 mg daily for 1 week and then increased to 15 mg daily for the remainder of the treatment period. Efficacy will primarily be evaluated by Positive And Negative Syndrome Scale (PANSS). Participants' safety will also be monitored at each visit.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Placebo First, Then Olanzapine | Placebo comparator | Drug: Olanzapine, Drug: PlaceboParticipants 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 | Experimental | Drug: JNJ-37822681, Drug: PlaceboParticipants 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 | Experimental | Drug: JNJ-37822681, Drug: PlaceboParticipants 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 | Experimental | Drug: JNJ-37822681Participants 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 comparator | Drug: Olanzapine, Drug: PlaceboParticipants 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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)
Key exclusion criteria (5 listed)
- 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)
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 |
|---|---|---|
| JNJ-37822681Participants will receive JNJ-37822681 capsule 10 mg orally twice a day for 12 consecutive weeks. | Drug | JNJ-37822681 10 mg |
| JNJ-37822681Participants will receive JNJ-37822681 capsule 20 mg orally twice a day for 12 consecutive weeks. | Drug | JNJ-37822681 20 mg |
| JNJ-37822681Participants will receive JNJ-37822681 capsule 30 mg orally twice a day for 12 consecutive weeks. | Drug | JNJ-37822681 30 mg |
| OlanzapineParticipants will receive olanzapine 10 mg capsule alone or in combination with olanzapine 5 mg capsule orally for 6 or 12 weeks. | Drug | Olanzapine, Placebo First, Then Olanzapine |
| PlaceboParticipants will receive matching placebo capsules orally for 12 weeks. | Drug | JNJ-37822681 10 mg, JNJ-37822681 20 mg, Olanzapine, Placebo First, Then Olanzapine |
Primary outcome
Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score at Week 6
Time frame: Baseline and 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.
11 secondary outcomes
Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Subscale Scores at Week 6 and 12
Time frame: Baseline, Week 6 and 12
Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Marder Subscale Scores at Week 6 and 12
Time frame: Baseline, Week 6 and 12
Change From Baseline in Clinical Global Impression-Severity (CGI-S) Score at Week 6 and 12
Time frame: Baseline, Week 6 and 12
Change From Baseline in Subjective Well-Being on Neuroleptics (SWN) Total Score at Week 6 and 12
Time frame: Baseline, Week 6 and 12
Change From Baseline in Nurses' Observation Scale for Inpatient Evaluation (NOSIE) Total Score at Week 2
Time frame: Baseline and Week 2
Change From Baseline in Plasma Markers Level for Lipid and Glucose Metabolism at Week 6 and 12
Time frame: Baseline, Week 6 and 12
Change From Baseline in Free Fatty Acids Level at Week 6 and 12
Time frame: Baseline, Week 6 and 12
Change From Baseline in Insulin Level at Week 6 and 12
Time frame: Baseline, Week 6 and 12
Change From Baseline in Glycosylated Hemoglobin (HbA1c) Level at Week 6 and 12
Time frame: Baseline, Week 6 and 12
Change From Baseline in Body Mass Index (BMI) at Week 6 and 12
Time frame: Baseline, Week 6 and 12
Change From Baseline in Body Weight at Week 6 and 12
Time frame: Baseline, Week 6 and 12
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 26 Mar 2014.
- Derived from this study: PubMed 22995972Anghelescu 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.
- 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 SchizophreniaLink 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.
Johnson & Johnson Pharmaceutical Research & Development, L.L.C Clinical Trial study director
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
45 sites in 10 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing JNJ-37822681 and Olanzapine in people with Schizophrenia, run by Johnson & Johnson Pharmaceutical Research & Development, L.L.C. at 45 sites in 10 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 5 inclusion and 5 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 26 Mar 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 45 sites in Russia, Romania, Ukraine, Bulgaria, South Korea and 5 more countries. 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. Some participants in this study may receive a placebo. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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.
What does the primary outcome measure?
Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score at Week 6 (time frame: Baseline and Week 6). 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 NCT00728195, which also lists 1 linked publication.
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 26 Mar 2014.