Status:
COMPLETED
Safety and Tolerability Study of Lu AF35700 After Repeated Dosing in Patients With Schizophrenia
Lead Sponsor:
H. Lundbeck A/S
Conditions:
Schizophrenia
Eligibility:
All Genders
18-60 years
Phase:
PHASE1
Brief Summary
The purpose of this study is to evaluate the tolerability and safety of Lu AF35700 after repeated oral dosing to patients with schizophrenia.
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
96 Patients enrolled
Trial Details
Trial ID
NCT02202226
Start Date
January 1 2013
Last Update
March 6 2015
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
PAREXEL Phase I Unit
Glendale, California, United States, 91206