An Evaluation of the Safety and Efficacy of ABT-925 in Subjects With Acute Exacerbation of Schizophrenia

April 25, 2011 updated by: Abbott

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

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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).

Study Type

Interventional

Enrollment (Actual)

156

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Buenos Aires, Argentina, CP1425
        • Site Reference ID/Investigator# 5227
      • Cordoba, Argentina, X5009BIN
        • Site Reference ID/Investigator# 5226
      • La Plata, Argentina, 1900
        • Site Reference ID/Investigator# 5224
      • Guadalajara, Mexico, 44280
        • Site Reference ID/Investigator# 4305
      • Mexico City, Mexico, CP 03740
        • Site Reference ID/Investigator# 4304
      • Mexico City, Mexico, CP 14000
        • Site Reference ID/Investigator# 4303
      • Monterrey, Mexico, CP 64000
        • Site Reference ID/Investigator# 4298
    • California
      • Anaheim, California, United States, 92805
        • Site Reference ID/Investigator# 5188
      • Cerritos, California, United States, 90703
        • Site Reference ID/Investigator# 4539
      • Garden Grove, California, United States, 92845
        • Site Reference ID/Investigator# 4175
      • Pico Rivera, California, United States, 90660
        • Site Reference ID/Investigator# 4553
      • San Diego, California, United States, 92126
        • Site Reference ID/Investigator# 4173
      • Upland, California, United States, 91786
        • Site Reference ID/Investigator# 4565
    • Florida
      • North Miami, Florida, United States, 33161
        • Site Reference ID/Investigator# 4177
    • Georgia
      • Atlanta, Georgia, United States, 30308
        • Site Reference ID/Investigator# 4168
    • Texas
      • Austin, Texas, United States, 78754
        • Site Reference ID/Investigator# 4567
      • Austin, Texas, United States, 78756
        • Site Reference ID/Investigator# 4176
      • Bellaire, Texas, United States, 77401
        • Site Reference ID/Investigator# 4371

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 60.
  • 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 35.
  • 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-925.
  • 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.
  • The subject has received any of the following treatments within the time periods described: mood stabilizers or antidepressants during the 30 days prior to Screening; electroconvulsive therapy during the 3 months prior to Screening; clozapine during 60 days prior to Screening.
  • The subject is currently receiving treatment with oral psychotropic medications or has received depot neuroleptics within one inter-injection interval.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Sugar Pill
Experimental: Group 1 Part 1 - ABT-925
Experimental: Group 1 Part 2 - ABT-925
Experimental: Group 2 - ABT-925

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Assessed at screening and weekly from baseline through week 42/premature discontinuation

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Brief Psychiatric Rating Scale
Time Frame: Assessed at screening and weekly from baseline through week 42/premature discontinuation
Subscale of PANSS (The Positive and Negative Syndrome Scale)
Assessed at screening and weekly from baseline through week 42/premature discontinuation
Clinical Global Impression Severity score
Time Frame: Assessed at screening and weekly from baseline through week 42/premature discontinuation
Assesses the overall, absolute degree of illness at any point in time (refer to the degree of illness at the time of the visit and during the week prior to the visit).
Assessed at screening and weekly from baseline through week 42/premature discontinuation
Calgary Depression Scale for Schizophrenia Total score
Time Frame: Assessed at screening and weekly from baseline through week 42/premature discontinuation
The CDSS (Calgary Depression Scale for Schizophrenia Total score) consists of items designed to assess the severity of symptoms of depression in the presence of schizophrenia such as depressed mood, hopelessness, guilt, and insomnia.
Assessed at screening and weekly from baseline through week 42/premature discontinuation
Negative Symptom Assessment
Time Frame: Assessed at screening and weekly from baseline through week 42/premature discontinuation
The NSA (Negative Symptom Assessment) is a 16-item instrument plus a one-item global rating designed to measure specific negative symptoms in schizophrenia
Assessed at screening and weekly from baseline through week 42/premature discontinuation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2006

Primary Completion (Actual)

October 1, 2007

Study Completion (Actual)

October 1, 2007

Study Registration Dates

First Submitted

December 14, 2006

First Submitted That Met QC Criteria

December 15, 2006

First Posted (Estimate)

December 18, 2006

Study Record Updates

Last Update Posted (Estimate)

April 27, 2011

Last Update Submitted That Met QC Criteria

April 25, 2011

Last Verified

September 1, 2010

More Information

Terms related to this study

Other Study ID Numbers

  • M06-816

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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