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An Evaluation of the Safety and Efficacy of ABT-925 in Subjects With Acute Exacerbation of Schizophrenia
This study has been terminated.
First Received: December 14, 2006   Last Updated: December 12, 2007   History of Changes
Sponsored by: Abbott
Information provided by: Abbott
ClinicalTrials.gov Identifier: NCT00412620
  Purpose

To explore the safety and efficacy of ABT-925 treatment compared with placebo in subjects with a diagnosis of acute exacerbation of schizophrenia or schizoaffective disorder.


Condition Intervention Phase
Schizophrenia
Drug: ABT-925
Phase II

MedlinePlus related topics: Schizophrenia
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title: Double-Blind, Randomized, Placebo-Controlled Study to Evaluate the Safety and Efficacy of ABT-925 in Subjects With Acute Exacerbation of Schizophrenia

Further study details as provided by Abbott:

Primary Outcome Measures:
  • Change from baseline to the final evaluation for the PANSS Total Score [ Time Frame: Day 42 ]

Secondary Outcome Measures:
  • CGI Severity and Improvement [ Time Frame: Day 42 ]
  • Calgary Depression Scale for Schizophrenia (CDSS) [ Time Frame: Day 42 ]
  • Negative Symptoms Assessment (NSA) [ Time Frame: Day 42 ]

Estimated Enrollment: 225
Study Start Date: December 2006
  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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 DSM-IV-TR criteria (and confirmed by the SCID I/P). Subjects with schizophrenia may belong to any of the following subtypes: paranoid, disorganized, catatonic, or undifferentiated
  • The subject has a PANSS total score of >= 60
  • The subject has a score of >= 4 ("moderate") on at least 2 out of the following 5 PANSS positive symptoms: delusions, conceptual disorganization, hallucinatory behavior, grandiosity, suspiciousness/persecution
  • The subject is male or female of non-childbearing potential (i.e., surgically sterilized or postmenopausal). Females of childbearing potential may participate in the study only if they meet all of the following: a) a negative pregnancy test (b hCG) at Screening; b) they must agree not to attempt to become pregnant during the course of the study; and c) if sexually active, they must agree to use a combination of two acceptable contraceptive methods for the duration of the study (e.g., hormonal, intra-uterine device, condom, diaphragm with a spermicide). Males that are not surgically sterile (vasectomy) may participate in the study only if a) sexually inactive, or b) agrees to use a barrier method of birth control (condom) for the duration of the study.
  • 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 person (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 any condition that is likely to interfere with his/her ability to complete the study and all the study-related procedures (e.g., blindness, deafness, language difficulties, sensory or motor deficits)
  • The subject has any condition which is likely to interfere significantly with the absorption, distribution, metabolism or excretion of the active treatment, including: malabsorption syndromes, previous GI surgery, active peptic ulcer disease, chronic GI disease etc.; evidence suggesting impaired kidney function (e.g., raised urea or creatinine with albuminuria or hematuria); any condition affecting plasma proteins (e.g., multiple myeloma, chronic medical illness)
  • 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 NOS (not otherwise specified) is acceptable for inclusion into the study)
  • The subject has a diagnosis of substance or alcohol disorder (abuse/dependence according to DSM-IV-TR 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 QTc interval of > 430 msec if male and > 450 msec if female
  • The subject has clinically significant abnormal laboratory values at Screening
  • The subject's LFTs (AST, ALT 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 a positive urine drug screen for non-prescribed drugs of abuse including but not limited to alcohol, cocaine, phencyclidine (PCP), opiates, barbiturates, tetrahydrocannabinol (THC), or amphetamines at any point prior to randomization
  • 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00412620

Locations
United States, Illinois
Global Medical Information - Abbott
Abbott Park, Illinois, United States, 60064
Sponsors and Collaborators
Abbott
Investigators
Study Director: Laura Redden, MD, PhD Abbott
  More Information

No publications provided

Study ID Numbers: M06-816
Study First Received: December 14, 2006
Last Updated: December 12, 2007
ClinicalTrials.gov Identifier: NCT00412620     History of Changes
Health Authority: United States: Food and Drug Administration

Keywords provided by Abbott:
Schizophrenia or schizoaffective disorder

Study placed in the following topic categories:
Schizophrenia
Mental Disorders
Psychotic Disorders
Schizophrenia and Disorders with Psychotic Features

Additional relevant MeSH terms:
Schizophrenia
Mental Disorders
Schizophrenia and Disorders with Psychotic Features

ClinicalTrials.gov processed this record on May 07, 2009