Schizophrenia
Conditions
Brief summary
The purpose of this study is to assess whether SCH 900435 (Org 25935) 16 mg twice daily is more effective than placebo in the treatment of patients with schizophrenia, using olanzapine 15 mg once daily as active control.
Interventions
DRUGSCH 900435 (Org 25935)
Oral tablets, containing 8 mg of active substance, two tablets (i.e. 16 mg) to be taken twice daily in the morning after breakfast and in the evening after dinner during 4 weeks. Because of double-dummy design, subjects will be administered two tablets in the morning, and two tablets plus one capsule in the evening (in total 4 tablets with SCH 900435 plus 1 capsule with placebo per day).
DRUGPlacebo
Oral capsules and tablets containing excipients only. Because of the double-dummy design, subjects will be administered one capsule in the evening, plus two tablets in the morning after breakfast and two tablets after dinner.
DRUGOlanzapine
Oral capsules containing 15 mg of active substance, one capsule to be taken once daily after dinner for four weeks. Because of double-dummy design, subjects will be administered two tablets in the morning, and two tablets plus one capsule in the evening (in total 4 tablets with placebo plus 1 capsule with olanzapine per day).
Sponsors
Merck Sharp & Dohme LLC
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Subjects eligible to participate: * present a substantial and recent exacerbation of schizophrenia * have responded positively to treatment with an antipsychotic other than clozapine in the past * are without adequate treatment for their symptoms, or willing and capable to stop concurrent medication, which appears inadequate to treat their condition, prior to participation
Exclusion criteria
* Schizoaffective disorder; * single episode of schizophrenia in partial remission * concomitant use of antidepressants, mood-stabilizers (including anticonvulsants) or long-acting sedatives * substance abuse or dependence (excluding nicotine and caffeine) * uncompensated medical illness (including clinically relevant eye disorder)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The change from baseline of the Positive and Negative Symptoms Scale (PANSS) (total score) | 4 weeks (Day 28) |
Secondary
| Measure | Time frame |
|---|---|
| Change from baseline in PANSS positive and negative subscale scores (in this order) as compared to olanzapine | 4 weeks |
Outcome results
None listed