Clinical trial NCT00412620: An Evaluation of the Safety and Efficacy of ABT-925 in Subjects With Acute Exacerbation of Schizophrenia
Official title: Double-blind, Randomized, Placebo-controlled Study to Evaluate the Safety and Efficacy of ABT-925 in Subjects With Acute Exacerbation of Schizophrenia
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Schizophrenia
Lead sponsor: Abbott
Sponsor class: INDUSTRY
First posted: 2006-12-18
Enrollment: 156
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).

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 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.

Primary outcomes:
measure: The Positive and Negative Syndrome Scale
timeFrame: Assessed at screening and weekly from baseline through week 42/premature discontinuation
Secondary outcomes:
measure: Brief Psychiatric Rating Scale
timeFrame: Assessed at screening and weekly from baseline through week 42/premature discontinuation
measure: Clinical Global Impression Severity score
timeFrame: Assessed at screening and weekly from baseline through week 42/premature discontinuation
measure: Calgary Depression Scale for Schizophrenia Total score
timeFrame: Assessed at screening and weekly from baseline through week 42/premature discontinuation
measure: Negative Symptom Assessment
timeFrame: Assessed at screening and weekly from baseline through week 42/premature discontinuation
Other outcomes:
Locations:
city: Anaheim
country: United States
facility: Site Reference ID/Investigator# 5188
state: California
city: Cerritos
country: United States
facility: Site Reference ID/Investigator# 4539
state: California
city: Garden Grove
country: United States
facility: Site Reference ID/Investigator# 4175
state: California
city: Pico Rivera
country: United States
facility: Site Reference ID/Investigator# 4553
state: California
city: San Diego
country: United States
facility: Site Reference ID/Investigator# 4173
state: California
city: Upland
country: United States
facility: Site Reference ID/Investigator# 4565
state: California
city: North Miami
country: United States
facility: Site Reference ID/Investigator# 4177
state: Florida
city: Atlanta
country: United States
facility: Site Reference ID/Investigator# 4168
state: Georgia
city: Austin
country: United States
facility: Site Reference ID/Investigator# 4567
state: Texas
city: Austin
country: United States
facility: Site Reference ID/Investigator# 4176
state: Texas
city: Bellaire
country: United States
facility: Site Reference ID/Investigator# 4371
state: Texas
city: Buenos Aires
country: Argentina
facility: Site Reference ID/Investigator# 5227
city: Cordoba
country: Argentina
facility: Site Reference ID/Investigator# 5226
city: La Plata
country: Argentina
facility: Site Reference ID/Investigator# 5224
city: Guadalajara
country: Mexico
facility: Site Reference ID/Investigator# 4305
city: Mexico City
country: Mexico
facility: Site Reference ID/Investigator# 4304
city: Mexico City
country: Mexico
facility: Site Reference ID/Investigator# 4303
city: Monterrey
country: Mexico
facility: Site Reference ID/Investigator# 4298
Study officials:
affiliation: Abbott
name: Beatrice Rendenbach-Mueller, PhD
role: STUDY_DIRECTOR
References:
citation: Redden L, Rendenbach-Mueller B, Abi-Saab WM, Katz DA, Goenjian A, Robieson WZ, Wang Y, Goss SL, Greco N 4th, Saltarelli MD. A double-blind, randomized, placebo-controlled study of the dopamine D(3) receptor antagonist ABT-925 in patients with acute schizophrenia. J Clin Psychopharmacol. 2011 Apr;31(2):221-5. doi: 10.1097/JCP.0b013e31820e4818.