Clinical trial NCT00922272: Efficacy, Safety, and Tolerability of SPD489 in Adults With Schizophrenia and Predominant Negative Symptoms
Official title: A Phase 2, Multicenter Study With Open-label & Randomized Double-blind Placebo-controlled Withdrawal Phases to Evaluate the Efficacy, Safety, & Tolerability of SPD489 in Adults With Schizophrenia & Predominant Negative Symptoms Who Are Clinically Stable & Taking Stable Doses of Atypical Antipsychotic Medication
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Schizophrenia and Predominant Negative Symptoms
Keywords: Schizophrenia
Lead sponsor: Takeda
Sponsor class: INDUSTRY
First posted: 2009-06-17
Enrollment: 92
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To explore the efficacy of SPD489, as adjunctive therapy to a stable dose of atypical antipsychotic medication, on negative symptoms in adult subjects with clinically stable schizophrenia and predominant negative symptoms, as measured by the Scale for the Assessment of Negative Symptoms (SANS).


Eligibility criteria: Inclusion Criteria:

* Adults aged 18-55
* Clinically stable Schizophrenia and predominant negative symptoms
* Taking a stable dose of antipsychotic medication

Exclusion Criteria:

* Clinically notable positive symptoms defined by PANSS

Primary outcomes:
measure: Change From Open-label Baseline in Modified Scale for the Assessment of Negative Symptoms (SANS-18) Total Score at Week 10 Open-label Phase, Last Observation Carried Forward (LOCF)
timeFrame: Open-label Baseline and Week 10 Open-label Phase
measure: Change From Double-blind Randomization Baseline in SANS-18 Total Score at Week 4 Double-blind Phase, Termination Observation Carried Forward (TOCF)
timeFrame: Double-blind Randomization Baseline and Week 4 Double-blind Phase
Secondary outcomes:
measure: Percent of Participants In Open-label Phase Who Were SANS-18 Responders at Week 10 Open-label Phase
timeFrame: Week 10 Open-label Phase
measure: Percent of Participants In Double-blind Phase Who Maintained SANS-18 Response at Week 4 Double-blind Phase
timeFrame: Week 4 Double-blind Phase
measure: Change From Open-label Baseline in SANS Global Scores at Week 10 Open-label Phase
timeFrame: Open-label Baseline and Week 10 Open-label Phase
measure: Change From Double-blind Randomization Baseline in SANS Global Scores at Week 4 Double-blind Phase
timeFrame: Double-blind Randomization Baseline and Week 4 Double-blind Phase
measure: Change From Open-label Baseline in Positive and Negative Syndrome Scale (PANSS) Scores at Week 10 Open-label Phase, LOCF
timeFrame: Open-label Baseline and Week 10 Open-label Phase
measure: Change From Double-blind Randomization Baseline in PANSS Scores at Week 4 Double-blind Phase, TOCF
timeFrame: Double-blind Randomization Baseline and Week 4 Double-blind Phase
measure: Percent of Participants With Clinical Global Impression - Severity of Illness (CGI-S) at Open-label Baseline
timeFrame: Open-label Baseline
measure: Percent of Participants With CGI-S at Week 10 Open-label Phase
timeFrame: Week 10 Open-label Phase
measure: Percent of Participants With CGI-S at Double-blind Randomization Baseline
timeFrame: Double-blind Randomization Baseline
measure: Percent of Participants With CGI-S at Week 4 Double-blind Phase
timeFrame: Week 4 Double-blind Phase
measure: Percent of Participants With Improvement on Clinical Global Impression - Change (CGI-C) at Week 10 Open-label Phase
timeFrame: Open-label Phase Week 10
measure: Percent of Participants With Improvement on CGI-C at Week 4 Double-blind Phase
timeFrame: Double-blind Phase Week 4
measure: Change From Open-label Baseline in the Brief Assessment of Cognition in Schizophrenia (BACS) Total Score at Week 10 Open-label Phase
timeFrame: Open-label Baseline and week 10 Open-label Phase
measure: Change From Double-blind Randomization Baseline in BACS Total Score at Week 4 Double-blind Phase
timeFrame: Double-blind Randomization Baseline and Week 4
measure: Change From Open-label Baseline in Letter-Number Span Test (LNS) Total Score at Week 10 Open-label Phase
timeFrame: Open-label Baseline and week 10 Open-label Phase
measure: Change From Double-blind Randomization Baseline in LNS Total Score at Week 4 Double-blind Phase
timeFrame: Double-blind Randomization Baseline and Week 4
measure: Change From Open-label Baseline in Hopkins Verbal Learning Test - Revised (HVLT-R) Total Score at Week 10 Open-label Phase
timeFrame: Open-label Baseline and Week 10
measure: Change From Double-blind Randomization Baseline in HVLT-R Total Scores at Week 4 Double-blind Phase
timeFrame: Double-blind Randomization Baseline and week 4 Double-blind Phase
measure: Change From Open-label Baseline in University of California Performance-Based Skills Assessment, Brief Version (UPSA-B) Scores at Week 10 Open-label Phase, LOCF
timeFrame: Open-label Baseline and week 10 Open-label Phase
measure: Change From Double-blind Randomization Baseline in UPSA-B Scores at Week 4 Double-blind Phase
timeFrame: Double-blind Randomization Baseline and Week 4 Double-blind Phase
measure: Change From Open-label Baseline in Behavioral Rating Inventory of Executive Function - Adult Version (BRIEF-A) T-scores at Week 10 Open-label Phase
timeFrame: Open-label Baseline and Week 10 Open-label Phase
measure: Change From Double-blind Randomization Baseline in BRIEF-A T-Scores at Week 4 Double-blind Phase
timeFrame: Double-blind Randomization Baseline and Week 4 Double-blind Phase
measure: Change From Open-label Baseline in Simpson Angus Scale (SAS) Total Score at Week 10 Open-label Phase
timeFrame: Open-label Baseline and Week 10 Open-label Phase
measure: Change From Open-label Baseline in SAS Total Score at Week 4 of Double-blind Phase
timeFrame: Open-label Baseline and Week 4 Double-blind Phase
measure: Change From Open-label Baseline in Barnes Akathisia Scale (BAS) Scores at Week 10 Open-label Phase
timeFrame: Open-label Baseline and week 10 Open-label Phase
measure: Change From Open-label Baseline in BAS Scores at Week 4 of Double-blind Phase
timeFrame: Open-label Baseline and Week 4 Double-blind Phase
measure: Change From Open-label Baseline in Amphetamine Cessation Symptom Assessment (ACSA) Total Score at Week 10 Open-label Phase
timeFrame: Open-label Baseline and Week 10 Open-label Phase
measure: Change From Double-blind Randomization Baseline in ACSA Total Score at Week 4 Double-blind Phase
timeFrame: Double-blind Randomization Baseline and Week 4 Double-blind Phase
measure: Change From Open-label Baseline in Pittsburgh Sleep Quality Index (PSQI) Total Global Score at Week 10 Open-label Phase
timeFrame: Open-label Baseline and Week 10 Open-label Phase
measure: Change From Open-label Baseline in PSQI Total Global Score at Week 4 of Double-blind Phase
timeFrame: Open-label Baseline and Week 4 Double-blind Phase
measure: Change From Open-label Baseline in Calgary Depression Scale for Schizophrenia (CDSS) at Week 10 Open-label Phase
timeFrame: Open-label Baseline and Week 10 Open-label Phase
measure: Change From Open-label Baseline in CDSS at Week 4 of Double-blind Phase
timeFrame: Open-label Baseline and Week 4 of Double-blind Phase
Other outcomes:
Locations:
city: Little Rock
country: United States
facility: K&S Professional Research Services
state: Arkansas
city: Anaheim
country: United States
facility: South Coast Clinical Trials
state: California
city: Anaheim
country: United States
facility: Omega Clinical Trials
state: California
city: Costa Mesa
country: United States
facility: Clinical Innovations
state: California
city: Garden Grove
country: United States
facility: Collaborative Neuroscience Network, Inc.
state: California
city: Long Beach
country: United States
facility: Apostle Clinical Trials, Inc.
state: California
city: Oceanside
country: United States
facility: Excell Research, Inc.
state: California
city: San Bernardino
country: United States
facility: Southcoast Clinical Trials
state: California
city: San Diego
country: United States
facility: CNRI San Diego & Los Angeles
state: California
city: San Diego
country: United States
facility: Affiliated Research Institute
state: California
city: San Diego
country: United States
facility: Artemis Institute for Clinical Research
state: California
city: Santa Ana
country: United States
facility: Neuropsychiatric Research Center of Orange County
state: California
city: Kissimmee
country: United States
facility: Accurate Clinical Trials
state: Florida
city: Lauderhill
country: United States
facility: Behavioral Clinical Research, INC
state: Florida
city: North Miami
country: United States
facility: Segal Institute for Clinical Research (Miami)
state: Florida
city: Orange City
country: United States
facility: Medical Research Group of Central Florida
state: Florida
city: Tampa
country: United States
facility: Stedman Clinical Trials
state: Florida
city: Atlanta
country: United States
facility: Comprehensive NeuroScience
state: Georgia
city: Chicago
country: United States
facility: Uptown Research Institute
state: Illinois
city: Shreveport
country: United States
facility: J. Gary Booker, MD, APMC
state: Louisiana
city: Willingboro
country: United States
facility: CRI Worldwide, LLC.
state: New Jersey
city: Elmsford
country: United States
facility: Advanced Bio-Behavioral Sciences
state: New York
city: Hollis
country: United States
facility: Comprehensive Neuroscience, Inc.
state: New York
city: Cincinnati
country: United States
facility: University of Cincinnati
state: Ohio
city: Philadelphia
country: United States
facility: CRI Worldwide
state: Pennsylvania
city: Austin
country: United States
facility: Community Clinical Research, Inc.
state: Texas
city: Irving
country: United States
facility: University Hills Clinical Research
state: Texas
Study officials:
affiliation: Takeda
name: Study Director
role: STUDY_DIRECTOR
References:
citation: Lasser RA, Dirks B, Nasrallah H, Kirsch C, Gao J, Pucci ML, Knesevich MA, Lindenmayer JP. Adjunctive lisdexamfetamine dimesylate therapy in adult outpatients with predominant negative symptoms of schizophrenia: open-label and randomized-withdrawal phases. Neuropsychopharmacology. 2013 Oct;38(11):2140-9. doi: 10.1038/npp.2013.111. Epub 2013 May 8.