Study of the Safety, Tolerability and Pharmacokinetics of Once Weekly Zicronapine in Patients With Schizophrenia

• Register: ClinicalTrials.gov
• Last refreshed on: 1 April 2013
• Main ID: NCT01377233
• Date of registration: 20/06/2011
• Primary sponsor: H. Lundbeck A/S
• Public title: Study of the Safety, Tolerability and Pharmacokinetics of Once Weekly Zicronapine in Patients With Schizophrenia
• Scientific title: A Randomised, Double-blind, Parallel-group, Explorative Study of the Safety, Tolerability and Pharmacokinetics of Daily Dosing Compared to Weekly Dosing of Zicronapine in Patients With Schizophrenia
• Date of first enrolment: July 2011
• Target sample size: 42
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT01377233
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Countries of recruitment

United States

Contacts

• Name: Email contact via H. Lundbeck A/S
• Affiliation: [e-mail]

Key inclusion & exclusion criteria

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.



Age minimum: 18 Years
Age maximum: 65 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Schizophrenia

Intervention(s)

Drug: Zicronapine

Primary Outcome(s)

Number of patients with adverse events as a measure of safety and tolerability [Time Frame: 5 weeks]

Secondary Outcome(s)

Clinical Global Impression Improvement Scale (CGI-I) [Time Frame: 5 weeks]

Clinical Global Impression Severity Scale (CGI-S) change from baseline [Time Frame: 5 weeks]

Plasma concentrations of zicronapine and its metabolite Lu AA22774 [Time Frame: 5 weeks]

Positive and Negative Syndrome Scale (PANSS) total and subscales change from baseline [Time Frame: 5 weeks]

Secondary ID(s)

13946A

Source(s) of Monetary Support

Please refer to primary and secondary sponsors