Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials
Trial record 1 of 1 for:    NCT00412620
Previous Study | Return to List | Next Study

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

This study has been terminated.
Sponsor:
Information provided by:
Abbott
ClinicalTrials.gov Identifier:
NCT00412620
First received: December 14, 2006
Last updated: April 25, 2011
Last verified: September 2010
  Purpose

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.


Condition Intervention Phase
Schizophrenia
Drug: ABT-925
Drug: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: Double-blind, Randomized, Placebo-controlled Study to Evaluate the Safety and Efficacy of ABT-925 in Subjects With Acute Exacerbation of Schizophrenia

Resource links provided by NLM:


Further study details as provided by Abbott:

Primary Outcome Measures:
  • The Positive and Negative Syndrome Scale [ Time Frame: Assessed at screening and weekly from baseline through week 42/premature discontinuation ] [ Designated as safety issue: No ]
    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 Outcome Measures:
  • Brief Psychiatric Rating Scale [ Time Frame: Assessed at screening and weekly from baseline through week 42/premature discontinuation ] [ Designated as safety issue: No ]
    Subscale of PANSS (The Positive and Negative Syndrome Scale)

  • Clinical Global Impression Severity score [ Time Frame: Assessed at screening and weekly from baseline through week 42/premature discontinuation ] [ Designated as safety issue: No ]
    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).

  • Calgary Depression Scale for Schizophrenia Total score [ Time Frame: Assessed at screening and weekly from baseline through week 42/premature discontinuation ] [ Designated as safety issue: No ]
    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.

  • Negative Symptom Assessment [ Time Frame: Assessed at screening and weekly from baseline through week 42/premature discontinuation ] [ Designated as safety issue: No ]
    The NSA (Negative Symptom Assessment) is a 16-item instrument plus a one-item global rating designed to measure specific negative symptoms in schizophrenia


Enrollment: 156
Study Start Date: December 2006
Study Completion Date: October 2007
Primary Completion Date: October 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Sugar Pill Drug: Placebo
Experimental: Group 1 Part 1 - ABT-925 Drug: ABT-925
Experimental: Group 1 Part 2 - ABT-925 Drug: ABT-925
Experimental: Group 2 - ABT-925 Drug: ABT-925

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).

  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 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00412620

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

No publications provided by Abbott

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Beatrice Rendenbach-Mueller, PhD, Project Director, Neuroscience/Anesthesia Department, Abbott Laboratories
ClinicalTrials.gov Identifier: NCT00412620     History of Changes
Other Study ID Numbers: M06-816
Study First Received: December 14, 2006
Last Updated: April 25, 2011
Health Authority: United States: Food and Drug Administration
Mexico: Ministry of Health
Argentina: Ministry of Health

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

ClinicalTrials.gov processed this record on November 20, 2014