Safety and Tolerability Study of Lu AF35700 After Repeated Dosing in Patients With Schizophrenia

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to evaluate the tolerability and safety of Lu AF35700 after repeated oral dosing to patients with schizophrenia.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: H. Lundbeck A/S

Criteria

Inclusion Criteria:

• Men or women between 18 and 60 years (extremes included)

• BMI of ≤38

• Primary diagnosis of schizophrenia according to DSM-IV-TR™ (codes 295.10, 295.20, 295.30, 295.90)

• Clinical Global Impression - Severity of Illness (CGI-S) score ≤4 (moderately ill) at screening and baseline

• PANSS total score ≤80

• Score ≤4 (moderate) on the following PANSS items at screening and safety baseline: P7 (hostility), G8 (uncooperativeness)

• Willing to be hospitalised for 4 to 5 weeks after the Safety Baseline Visit

Exclusion Criteria:

• The patient experienced an acute exacerbation requiring hospitalization within the last 6 months

• The patient experienced an acute exacerbation requiring change in antipsychotic medication (with reference to drug or dose) within the last 4 weeks

• The patient has a diagnosis or history of substance dependence (except nicotine) or substance abuse according to DSM-IV-TR® criteria ≤3 months prior to screening

• The patient smokes >20 cigarettes per day

Other protocol-defined inclusion and exclusion criteria may apply