Interventional, Randomised, Double-blind, Active-controlled, Fixed-dose Study of Lu AF35700 in Patients With Treatment-resistant Schizophrenia (DayBreak)

NCT02717195 Phase 3 COMPLETED Results posted

To evaluate the efficacy of 10 and 20 mg/day of Lu AF35700 on schizophrenia symptoms in patients with treatment-resistant schizophrenia (TRS)

Details

Lead sponsor	H. Lundbeck A/S
Phase	Phase 3
Status	COMPLETED
Enrolment	1098
Start date	2016-04
Completion	2018-10-08

Conditions

• Schizophrenia

Interventions

• Risperidone
• Olanzapine
• Lu AF35700
• Lu AF35700

Primary outcomes

• Change From Randomization to Week 10 in Positive and Negative Syndrome Scale (PANSS) Total Score — From Randomization to Week 10
  PANSS total score administered by the investigator. It included 3 sub-scales with a total of 30 items that evaluated the Positive Symptoms subscale, the Negative Symptoms subscale, the General Psychopathology subscale. Each item is rated from 1 (symptom not present) to 7 (symptom extremely severe). PANSS total score was calculated as sum of all the items on the scale and ranged from 30 to 210. A higher score corresponded to a worse severity of schizophrenia.

Countries

United States, Bulgaria, Canada, Czechia, Estonia, Finland, Mexico, Poland, Romania, Russia, Serbia, Slovakia, Spain, Ukraine