A Schizophrenia Phase III study

• Conditions: Therapeutic area: Psychiatry and Psychology [F] - Mental Disorders [F03]; Schizophrenia; MedDRA version: 17.0Level: LLTClassification code 10001064Term: Acute schizophreniaSystem Organ Class: 100000004873

• Registration Number: EUCTR2012-005271-14-RO
• Lead Sponsor: Sunovion Pharmaceuticals Inc

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2014-07-28
• Last Update Posted: 11 August 2014

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 400

Inclusion Criteria

Subject is = 18 and = 75 years of age, and meets DSM-IV-TR criteria for a primary diagnosis of schizophrenia [including disorganized (295.10), paranoid (295.30), undifferentiated (295.90) subtypes] as established by clinical interview (using the DSM-IV-TR as a reference and confirmed by the SCID-CT). The duration of the subject’s illness whether treated or untreated must be = 6 months. Subject has a PANSS total score = 80 and PANSS subscale score = 4 (moderate) on 2 or more of the following PANSS subscale items: delusions, conceptual disorganization, hallucinations, and unusual thought content at screening and baseline and a CGI-S score of = 4 at screening and baseline. Subject has an acute exacerbation of psychotic symptoms (no longer than 2 months) and marked deterioration of function from baseline (by history) or subject has been hospitalized for the purpose of treating an acute psychotic exacerbation for 2 consecutive weeks or less immediately before screening.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 380
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 20

Exclusion Criteria

Diagnosis of a DSM-IV Axis I or Axis II diagnosis, other than schizophrenia, that has been the primary focus of treatment within 3 months of screening. Considered by the investigator to be at imminent risk of suicide or injury to self, others, or property.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified