Expired Study
This study is not currently recruiting Study Participants on ClinicalConnection.com. If you would like to find active studies please search for clinical trials.

Rockville, Maryland 20850


The main purpose of this study is to evaluate the safety, tolerability and pharmacokinetics of once-a-week dosing of zicronapine, compared to daily dosing of zicronapine.

Study summary:

The study includes 2 treatment periods. The open-label, run-in, period will begin at patient enrolment into the study and continue for 3 weeks; during which all patients will receive treatment with zicronapine daily. The double-blind period will begin at patient randomization and continue for 5 weeks; during which the patients will be assigned to one group receiving treatment with zicronapine daily and 3 groups receiving once-a-week treatment with zicronapine.


Inclusion Criteria: - Diagnosis of schizophrenia according to the Diagnostic and Statistic Manual, fourth edition (DSM-IV) - A severity score of Clinical Global Impression Scale (CGI) >=4 - A total score of Positive and Negative Syndrome Scale (PANSS) >=60 - A score of <=4 (moderate) on PANSS items: P7 (hostility) AND G8 (uncooperativeness) Exclusion Criteria: - Acute exacerbation which required hospitalization within the last 3 months OR required change of antipsychotic medication within the last 4 weeks - A current diagnosis or a history of substance dependence or substance abuse according to the DSM-IV-TR in the past 3 months - A significant risk of harming himself/herself or others - A positive serology for Hepatitis A, B, C, or HIV - A present condition that might compromise liver function - A medical or neurological disorder or treatment that could interfere with study treatment or compliance Other inclusion and exclusion criteria may apply.



Primary Contact:

Study Director
Email contact via H. Lundbeck A/S

Backup Contact:


Location Contact:

Rockville, Maryland 20850
United States

There is no listed contact information for this specific location.

Site Status: N/A

Data Source: ClinicalTrials.gov

Date Processed: October 09, 2019

Modifications to this listing: Only selected fields are shown, please use the link below to view all information about this clinical trial.

Click to view Full Listing

This study is not currently recruiting Study Participants on ClinicalConnection.com. The form below is not enabled.