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MK-8435 (Org 25935) for negative symptoms of schizophrenia
NCT00725075Phase 2
Key facts
- Status
- Completed
- Start
- Apr 2007
- Primary completion
- Oct 2008
- Sponsor
- Merck & Co.
- Modality
- Small Molecules
- Drugs
- org 25935
- Conditions
- schizophrenia
01
Overview
Phase 2, randomised, double-blind trial of org 25935 in schizophrenia (3 arms), sponsored by Merck & Co. Primary endpoint: Change From Baseline in Modified Scale for the Assessment of Negative Symptoms (SANS 1-22 Composite Score) at 12 weeks. Started Apr 2007; status: completed.
02
Design
3 arms- Study design
- RandomizedDouble-blind
MK-8435 Low Dose
MK-8435 8-16 mg/day + SGA
MK-8435 High Dose
MK-8435 24-32 mg/day + SGA
Placebo
Placebo + SGA
03
Who it enrols
Patients with non-first episode schizophrenia, clinically stable for 3 months on a stable dose of a second generation antipsychotic. Must have predominant negative symptoms (PANSS negative subscale score > 20 and score >= 4 on 3 or more specific negative items). Excludes patients with high positive symptom scores (PANSS positive subscale >= 20).
04
Endpoints
Primary
Change From Baseline in Modified Scale for the Assessment of Negative Symptoms (SANS 1-22 Composite Score)
Secondary
Change From Baseline in Total Score of Positive and Negative Syndrome Scale (PANSS)
Change From Baseline in the Calgary Depression Scale for Schizophrenia (CDSS)
Change From Baseline in Cognitive Domains (Perception of Emotions, Non-Verbal Reasoning, Verbal Memory, Visual Memory, Speed of Complex Information Processing, Working Memory, Sustained Attention,…
Change From Baseline in Extrapyramidal Symptoms Rating Scale Score
05
Results
Not all primary endpoints met
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