Clinical trial NCT00728195: An Efficacy and Safety Study of 3 Fixed Doses of JNJ-37822681 in Participants With Schizophrenia
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Schizophrenia
Keywords: Schizophrenia
Central Nervous System
JNJ-37822681
Lead sponsor: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Sponsor class: INDUSTRY
First posted: 2008-08-05
Enrollment: 498
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).

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.

Eligibility criteria: Inclusion Criteria:

* 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)

Exclusion Criteria:

* 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)

Primary outcomes:
measure: Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score at Week 6
timeFrame: Baseline and Week 6
Secondary outcomes:
measure: Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Subscale Scores at Week 6 and 12
timeFrame: Baseline, Week 6 and 12
measure: Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Marder Subscale Scores at Week 6 and 12
timeFrame: Baseline, Week 6 and 12
measure: Change From Baseline in Clinical Global Impression-Severity (CGI-S) Score at Week 6 and 12
timeFrame: Baseline, Week 6 and 12
measure: Change From Baseline in Subjective Well-Being on Neuroleptics (SWN) Total Score at Week 6 and 12
timeFrame: Baseline, Week 6 and 12
measure: Change From Baseline in Nurses' Observation Scale for Inpatient Evaluation (NOSIE) Total Score at Week 2
timeFrame: Baseline and Week 2
measure: Change From Baseline in Plasma Markers Level for Lipid and Glucose Metabolism at Week 6 and 12
timeFrame: Baseline, Week 6 and 12
measure: Change From Baseline in Free Fatty Acids Level at Week 6 and 12
timeFrame: Baseline, Week 6 and 12
measure: Change From Baseline in Insulin Level at Week 6 and 12
timeFrame: Baseline, Week 6 and 12
measure: Change From Baseline in Glycosylated Hemoglobin (HbA1c) Level at Week 6 and 12
timeFrame: Baseline, Week 6 and 12
measure: Change From Baseline in Body Mass Index (BMI) at Week 6 and 12
timeFrame: Baseline, Week 6 and 12
measure: Change From Baseline in Body Weight at Week 6 and 12
timeFrame: Baseline, Week 6 and 12
Other outcomes:
Locations:
city: Bourgas
country: Bulgaria
city: Pazardjik
country: Bulgaria
city: Radnevo
country: Bulgaria
city: Rousse
country: Bulgaria
city: Sofia N/A
country: Bulgaria
city: Tallinn
country: Estonia
city: Tartu N/A
country: Estonia
city: Gwangju
country: Korea, Republic of
city: Gyeongsangnam-Do
country: Korea, Republic of
city: Incheon
country: Korea, Republic of
city: Seoul
country: Korea, Republic of
city: Kaunas
country: Lithuania
city: Vilnius
country: Lithuania
city: Johor Bahru
country: Malaysia
city: Kuala Lumpur
country: Malaysia
city: Kuching
country: Malaysia
city: Arad
country: Romania
city: Brasov
country: Romania
city: Bucharest
country: Romania
city: Bucuresti
country: Romania
city: Jebel
country: Romania
city: Oradea
country: Romania
city: Sibiu
country: Romania
city: Tg Mures
country: Romania
city: Ekaterinburg Na
country: Russian Federation
city: Moscow N/A
country: Russian Federation
city: Moscow Russia
country: Russian Federation
city: N Novgorod Na
country: Russian Federation
city: Samara
country: Russian Federation
city: Saratov
country: Russian Federation
city: St Petersburg N/A
country: Russian Federation
city: St Petersburg
country: Russian Federation
city: St-Petersburg
country: Russian Federation
city: Tomsk Na
country: Russian Federation
city: Yaroslavl
country: Russian Federation
city: Cape Town
country: South Africa
city: Centurion Gauteng
country: South Africa
city: Pretoria
country: South Africa
city: Hua Lian
country: Taiwan
city: Kaohsiung
country: Taiwan
city: Taipei
country: Taiwan
city: Dnipropetrovsk
country: Ukraine
city: Donetsk
country: Ukraine
city: Kharkov
country: Ukraine
city: Kherson
country: Ukraine
city: Kiev
country: Ukraine
city: Odessa
country: Ukraine
city: Simferopol
country: Ukraine
Study officials:
affiliation: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
name: Johnson & Johnson Pharmaceutical Research & Development, L.L.C Clinical Trial
role: STUDY_DIRECTOR
References:
citation: 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.