Schizophrenia
Conditions
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.
Interventions
DRUGLu AF35700
DRUGPlacebo
Sponsors
H. Lundbeck A/S
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Absolute values and change from baseline in safety variables (Adverse events, clinical safety laboratory tets, vital signs, weight, and ECG) | Screening to day 78 (up to 8 weeks after last dose) | — |
| Change from baseline in AIMS, BARS and SAS Total score | Baseline to day 21 | Abnormal movement rating scale |
| Columbia Suicide Severity Rating Scale (C-SSRS) | Sceening to day 78 (up to 8 weeks after last dose) | — |
Secondary
| Measure | Time frame |
|---|---|
| Maximum observed concentration (Cmax) of Lu AF35700 and Lu AF36152 | Day 1 and 21 in the dosing period |
| Day 21 area under the Lu AF35700 and Lu AF36152 plasma concentration-time curve from 0-24 hours post dose (AUC0-tau) in a daily dosing regime | Day 21 in the dosing period |
| Half-lives (t½) of Lu AF35700 and Lu AF36152 | Day 1 and 21 in the dosing period |
| Day 14-21 area under the Lu AF35700 and LuAF36152 plasma-concentration-time curve from 0-168 hours post-dose (AUCtau) in a weekly dosing regimen | Day 14-21 in the dosing period |
Countries
United States
Outcome results
None listed