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.
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
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
156
Site Reference ID/Investigator# 5188
Anaheim, California, United States
Site Reference ID/Investigator# 4539
Cerritos, California, United States
The Positive and Negative Syndrome Scale
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.
Time frame: Assessed at screening and weekly from baseline through week 42/premature discontinuation
Brief Psychiatric Rating Scale
Subscale of PANSS (The Positive and Negative Syndrome Scale)
Time frame: Assessed at screening and weekly from baseline through week 42/premature discontinuation
Clinical Global Impression Severity score
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).
Time frame: Assessed at screening and weekly from baseline through week 42/premature discontinuation
Calgary Depression Scale for Schizophrenia Total score
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.
Time frame: Assessed at screening and weekly from baseline through week 42/premature discontinuation
Negative Symptom Assessment
The NSA (Negative Symptom Assessment) is a 16-item instrument plus a one-item global rating designed to measure specific negative symptoms in schizophrenia
Time frame: Assessed at screening and weekly from baseline through week 42/premature discontinuation
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Site Reference ID/Investigator# 4175
Garden Grove, California, United States
Site Reference ID/Investigator# 4553
Pico Rivera, California, United States
Site Reference ID/Investigator# 4173
San Diego, California, United States
Site Reference ID/Investigator# 4565
Upland, California, United States
Site Reference ID/Investigator# 4177
North Miami, Florida, United States
Site Reference ID/Investigator# 4168
Atlanta, Georgia, United States
Site Reference ID/Investigator# 4567
Austin, Texas, United States
Site Reference ID/Investigator# 4176
Austin, Texas, United States
...and 8 more locations