Clinical trial NCT01295372: Safety and Efficacy of Zicronapine in Patients With Schizophrenia
Official title: A 6-month, Randomised, Double-blind, Parallel-group, Risperidone-controlled, Fixed-dose Study Evaluating the Safety and Efficacy of Zicronapine in Patients With Schizophrenia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Schizophrenia
Keywords: Schizophrenia
Antipsychotic
Risperidone
Lu 31-130
Lead sponsor: H. Lundbeck A/S
Sponsor class: INDUSTRY
First posted: 2011-02-14
Enrollment: 160
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To assess the effect of zicronapine versus risperidone on metabolic parameters comprising body weight, body mass index (BMI), waist circumference, levels of fasting blood lipids and glucose during 6 months of treatment.

Detailed description: Schizophrenia is a serious and disabling mental disorder that affects approximately 1% of the world's population. Antipsychotic drugs remain the cornerstone in the pharmacotherapy of schizophrenia. There are a number of antipsychotic drugs in use but none is ideal, in particular because their safety profile is complex and their effectiveness is limited.

Thus, present treatment options leave room for improvement and call for new, more effective pharmacotherapies for the treatment of schizophrenia. In the current study, non-acute patients with schizophrenia will be randomised to blinded treatment with either zicronapine or a standard antipsychotic treatment for 24 weeks. The safety (with focus on metabolic parameters) and efficacy of zicronapine will be evaluated in comparison to risperidone.

Eligibility criteria: Inclusion Criteria:

* The patient meets the Diagnostic and Statistical Manual of Mental Disorders, 4th edition, Text Revision (DSM-IV-TR) criteria for schizophrenia
* The patient is a man or woman, ≥18 and ≤65 years old
* The patient has a PANSS total score ≥60 and ≤100 (extremes included) at screening and baseline

Exclusion Criteria:

* The patient has a current, predominant Axis I psychiatric disorder other than schizophrenia as defined in the DSM-IV-TR
* The patient has a current diagnosis or a history of substance dependence (except nicotine) or substance abuse (except cannabis) according to the DSM-IV-TR criteria ≤6 months prior to screening
* The patient is at significant risk of harming him/herself or others according to the investigator's judgement (assisted by the assessment of suicidal ideation and behaviour using the C-SSRS)
* The patient is resistant to antipsychotic treatment according to the investigator's judgement or has been treated with clozapine ≤3 months prior to screening
* The patient has experienced an acute exacerbation requiring hospitalisation ≤3 months prior to screening or between screening and baseline
* The patient has been treated with risperidone or paliperidone ≤6 months prior to screening

Other inclusion and exclusion criteria may apply.

Primary outcomes:
measure: To assess the effect of zicronapine versus risperidone on body weight (and BMI)
timeFrame: 6 months
measure: To assess the effect of zicronapine versus risperidone on waist circumference
timeFrame: 6 months
measure: To assess the effect of zicronapine versus risperidone on levels of fasting blood lipids
timeFrame: 6 months
measure: To assess the effect of zicronapine versus risperidone on levels of fasting blood glucose
timeFrame: 6 months
Secondary outcomes:
measure: To assess the overall safety and tolerability of zicronapine versus risperidone during 6 months of treatment by comparing the frequencies of adverse events sorted by system organ class and preferred term.
timeFrame: 6 months
measure: To assess the potential of zicronapine versus risperidone to induce extrapyramidal symptoms using change from baseline to each assessment in the AIMS, BARS, and SAS total scores
timeFrame: 6 months
measure: To assess the effect of zicronapine versus risperidone on serum prolactin levels
timeFrame: 6 months
measure: To assess the effect of zicronapine on suicidal ideation and behaviour using the Columbia Suicide-Severity Rating Scale (C-SSRS)
timeFrame: 6 months
measure: To assess the effect of zicronapine versus risperidone on electrocardiogram (ECG) parameters
timeFrame: 6 months
measure: To assess the efficacy of zicronapine versus risperidone following 6 months of treatment using change from baseline in the Positive and Negative Syndrome Scale (PANSS) total score
timeFrame: 6 months
measure: To assess the efficacy of zicronapine versus risperidone using change from baseline to each assessment in the PANSS total score and PANSS subscale scores (Positive Symptoms, Negative Symptoms, and General Psychopathology)
timeFrame: 6 months
measure: To assess the efficacy of zicronapine versus risperidone by comparing the proportions of responders (using two definitions of response: ≥20% and ≥50% decrease from baseline in PANSS total score)
timeFrame: 6 months
measure: To assess the efficacy of zicronapine versus risperidone on global improvement using change from baseline to each assessment in the Clinical Global Impression - Severity of Illness (CGI-S) score
timeFrame: 6 months
measure: To assess the effect of zicronapine versus risperidone on personal and social functioning using the Personal and Social Performance Scale (PSP)
timeFrame: 6 months
measure: To assess the effect of zicronapine versus risperidone on functioning using the Global Assessment of Functioning scale (GAF)
timeFrame: 6 months
measure: To assess the effect of zicronapine versus risperidone on quality of life using the disease-specific Schizophrenia Quality of Life scale (S-QoL)
timeFrame: 6 months
measure: To assess the effect of zicronapine versus risperidone on the patient's satisfaction with treatment using the Medication Satisfaction Questionnaire (MSQ)
timeFrame: 6 months
Other outcomes:
Locations:
city: Brno
country: Czech Republic
facility: CZ004
city: Brno
country: Czech Republic
facility: CZ001
city: Kladno
country: Czech Republic
facility: CZ007
city: Liberec
country: Czech Republic
facility: CZ003
city: Olomouc
country: Czech Republic
facility: CZ002
city: Praha
country: Czech Republic
facility: CZ008
city: Praha
country: Czech Republic
facility: CZ006
city: Sternberk
country: Czech Republic
facility: CZ005
city: Pärnu
country: Estonia
facility: EE003
city: Tallinn
country: Estonia
facility: EE001
city: Tallinn
country: Estonia
facility: EE002
city: Tartu
country: Estonia
facility: EE004
city: Helsinki
country: Finland
facility: FI001
city: Kellokoski
country: Finland
facility: FI002
city: Clermont Ferrand
country: France
facility: FR001
city: Nimes
country: France
facility: FR002
city: Strasbourg
country: France
facility: FR004
city: Toulon
country: France
facility: FR003
city: Bełchatów
country: Poland
facility: PL004
city: Gdańsk
country: Poland
facility: PL002
city: Kielce
country: Poland
facility: PL003
city: Lublin
country: Poland
facility: PL001
city: Łódź
country: Poland
facility: PL006
city: Żuromin
country: Poland
facility: PL005
Study officials:
affiliation: LundbeckClinicalTrials@lundbeck.com
name: Email contact via H. Lundbeck A/S
role: STUDY_DIRECTOR
References: