Double-blind, Randomized, Placebo-controlled Study to Evaluate the Safety and Efficacy of ABT-925 in Subjects With Acute Exacerbation of Schizophrenia

Abbott18 sites in 3 countries156 target enrollmentDecember 2006

ConditionsSchizophrenia

InterventionsPlacebo ABT-925

DrugsABT-925 Placebo

Overview

Phase: Phase 2
Intervention: Placebo
Conditions: Schizophrenia
Sponsor: Abbott
Enrollment: 156
Locations: 18
Primary Endpoint: The Positive and Negative Syndrome Scale
Status: Terminated
Last Updated: 15 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

The objective of this study is to explore the safety and efficacy of ABT-925 involving patients who meet the DSM-IV-TR (Diagnostic and Statistical Manual of Medical Disorders, Fourth Edition Text Revision) criteria for an acute exacerbation of schizophrenia or schizoaffective disorder.

Detailed Description

To explore the safety and efficacy of ABT-925 treatment at three different doses for 6 weeks compared with placebo in subjects with a diagnosis of acute exacerbation of schizophrenia or schizoaffective disorder according to DSM-IV-TR criteria (Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition Text Revision).

Registry

clinicaltrials.gov

Start Date

December 2006

End Date

October 2007

Last Updated

15 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Abbott

Eligibility Criteria

Inclusion Criteria

•The subject has a current primary diagnosis of schizophrenia or schizoaffective disorder; specifically, an acute exacerbation with prominent "active phase" symptoms, as described in Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition Text Revision criteria (and confirmed by the Structured Clinical Interview for Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition Text Revision). Subjects with schizophrenia may belong to any of the following subtypes: paranoid, disorganized, catatonic, or undifferentiated.
•The subject has a The Positive and Negative Syndrome Scale total score of greater than or equal to
•The subject has a score of greater than 4 ("moderate") on at least 2 out of the following 5 The Positive and Negative Syndrome Scale positive symptoms: delusions, conceptual disorganization, hallucinatory behavior, grandiosity, suspiciousness/persecution.
•The subject is between 18 and 65 years old inclusive at the time of randomization.
•The subject has a reliable caregiver (if applicable) or an identified responsible (e.g., family member, social worker, nurse) who will support him/her to ensure compliance with treatment and outpatient visits. In addition, the subject must have an adequate place of residence.
•The subject agrees to be hospitalized for the duration of the Taper off/Washout Period and at least the first fourteen days of the Double-blind Period.

Exclusion Criteria

•The subject has a body mass index greater than
•The subject has any condition that in the opinion of the investigator is likely to place him/her at an unacceptable safety risk by entering the study or by treatment with ABT-
•The subject has a diagnosis of one or more of the following conditions: another primary Axis I disorder, including schizophreniform disorder, bipolar disorder or major depressive disorder; comorbid Axis II diagnoses, including borderline personality disorder and mental retardation. (Note: a diagnosis of depression not otherwise specified is acceptable for inclusion into the study).
•The subject has a diagnosis of substance or alcohol disorder (abuse/dependence according to Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition Text Revision criteria), excluding nicotine, within one (1) month prior to the beginning of the Screening Period, or in the opinion of the investigator, a disorder that will interfere with the conduct of the study.
•The subject has a history of substance-induced psychotic disorder in the previous 6 months.
•The subject has evidence suggestive of treatment-resistant schizophrenia (i.e., lack of significant clinical improvement despite adequate courses and doses of at least two different antipsychotic medications during the previous 2 years; or adequate use of clozapine indicated for treatment-resistant schizophrenia).
•The subject has serious violent, homicidal or suicidal ideation in the opinion of the investigator.
•The subject has a screening QT interval corrected by Bazett formula interval of greater than 430 msec if male and greater than 450 msec if female.
•The subject's Liver Function Tests (Aspartate aminotransferases, Alanine aminotransferase or total bilirubin levels) are not within normal limits at screening.
•The subject has a diagnosis, history, or a positive serological result suggestive of liver disease including but not limited to hepatitis and Gilbert's Syndrome.

Arms & Interventions

Sugar Pill

Intervention: Placebo

Group 1 Part 1 - ABT-925

Intervention: ABT-925

Group 1 Part 2 - ABT-925

Intervention: ABT-925

Group 2 - ABT-925

Intervention: ABT-925

Outcomes

Primary Outcomes

The Positive and Negative Syndrome Scale

Time Frame: Assessed at screening and weekly from baseline through week 42/premature discontinuation

The PANSS (The Positive and Negative Syndrome Scale) assesses the severity of symptoms of schizophrenia over the preceding seven days. The PANSS items are divided into positive, negative, and general psychopathology factors. The PANSS total score is the score of all 30 PANSS items taken together.

Secondary Outcomes

Brief Psychiatric Rating Scale(Assessed at screening and weekly from baseline through week 42/premature discontinuation)
Clinical Global Impression Severity score(Assessed at screening and weekly from baseline through week 42/premature discontinuation)
Calgary Depression Scale for Schizophrenia Total score(Assessed at screening and weekly from baseline through week 42/premature discontinuation)
Negative Symptom Assessment(Assessed at screening and weekly from baseline through week 42/premature discontinuation)