Efficacy, Safety, and Tolerability of SPD489 in Adults With Schizophrenia and Predominant Negative Symptoms
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
1 other identifier
interventional
92
1 country
27
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Sep 2009
Shorter than P25 for phase_2
27 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 15, 2009
CompletedFirst Posted
Study publicly available on registry
June 17, 2009
CompletedStudy Start
First participant enrolled
September 14, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 20, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
January 20, 2011
CompletedResults Posted
Study results publicly available
February 20, 2012
CompletedJune 9, 2021
May 1, 2021
1.4 years
June 15, 2009
December 6, 2011
May 25, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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)
The SANS was modified by eliminating the global and attention items; the score of the remaining non-global items is referred to as the SANS-18 total score. Each of the 18-items is scored on a scale from 0 (not at all) to 5 (severe) with a total scoring range of 0 to 90. Higher scores indicate more impairment.
Open-label Baseline and Week 10 Open-label Phase
Change From Double-blind Randomization Baseline in SANS-18 Total Score at Week 4 Double-blind Phase, Termination Observation Carried Forward (TOCF)
The SANS was modified by eliminating the global and attention items; the score of the remaining non-global items is referred to as the SANS-18 total score. Each of the 18-items is scored on a scale from 0 (not at all) to 5 (severe) with a total scoring range of 0 to 90. Higher scores indicate more impairment.
Double-blind Randomization Baseline and Week 4 Double-blind Phase
Secondary Outcomes (32)
Percent of Participants In Open-label Phase Who Were SANS-18 Responders at Week 10 Open-label Phase
Week 10 Open-label Phase
Percent of Participants In Double-blind Phase Who Maintained SANS-18 Response at Week 4 Double-blind Phase
Week 4 Double-blind Phase
Change From Open-label Baseline in SANS Global Scores at Week 10 Open-label Phase
Open-label Baseline and Week 10 Open-label Phase
Change From Double-blind Randomization Baseline in SANS Global Scores at Week 4 Double-blind Phase
Double-blind Randomization Baseline and Week 4 Double-blind Phase
Change From Open-label Baseline in Positive and Negative Syndrome Scale (PANSS) Scores at Week 10 Open-label Phase, LOCF
Open-label Baseline and Week 10 Open-label Phase
- +27 more secondary outcomes
Study Arms (2)
SPD489 (Lisdexamfetamine dimesylate)
EXPERIMENTALPlacebo
PLACEBO COMPARATORPlacebo
Interventions
oral, 20, 30, 40, 50, 60, or 70 mg once daily
Eligibility Criteria
You may qualify if:
- Adults aged 18-55
- Clinically stable Schizophrenia and predominant negative symptoms
- Taking a stable dose of antipsychotic medication
You may not qualify if:
- Clinically notable positive symptoms defined by PANSS
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Shirelead
Study Sites (27)
K&S Professional Research Services
Little Rock, Arkansas, 72201, United States
South Coast Clinical Trials
Anaheim, California, 92804, United States
Omega Clinical Trials
Anaheim, California, 92805, United States
Clinical Innovations
Costa Mesa, California, 92626, United States
Collaborative Neuroscience Network, Inc.
Garden Grove, California, 92845, United States
Apostle Clinical Trials, Inc.
Long Beach, California, 90813, United States
Excell Research, Inc.
Oceanside, California, 92056, United States
Southcoast Clinical Trials
San Bernardino, California, 92405, United States
CNRI San Diego & Los Angeles
San Diego, California, 92102, United States
Affiliated Research Institute
San Diego, California, 92108, United States
Artemis Institute for Clinical Research
San Diego, California, 92123, United States
Neuropsychiatric Research Center of Orange County
Santa Ana, California, 92701, United States
Accurate Clinical Trials
Kissimmee, Florida, 34741, United States
Behavioral Clinical Research, INC
Lauderhill, Florida, 33319, United States
Segal Institute for Clinical Research (Miami)
North Miami, Florida, 33161, United States
Medical Research Group of Central Florida
Orange City, Florida, 32763, United States
Stedman Clinical Trials
Tampa, Florida, 33613, United States
Comprehensive NeuroScience
Atlanta, Georgia, 30328, United States
Uptown Research Institute
Chicago, Illinois, 60640, United States
J. Gary Booker, MD, APMC
Shreveport, Louisiana, 71104, United States
CRI Worldwide, LLC.
Willingboro, New Jersey, 08046, United States
Advanced Bio-Behavioral Sciences
Elmsford, New York, 10523, United States
Comprehensive Neuroscience, Inc.
Hollis, New York, 11423, United States
University of Cincinnati
Cincinnati, Ohio, 45219, United States
CRI Worldwide
Philadelphia, Pennsylvania, 19139, United States
Community Clinical Research, Inc.
Austin, Texas, 78756, United States
University Hills Clinical Research
Irving, Texas, 75062, United States
Related Publications (1)
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.
PMID: 23756608RESULT
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Study Director
- Organization
- Shire
Study Officials
- STUDY DIRECTOR
Study Director
Takeda
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 15, 2009
First Posted
June 17, 2009
Study Start
September 14, 2009
Primary Completion
January 20, 2011
Study Completion
January 20, 2011
Last Updated
June 9, 2021
Results First Posted
February 20, 2012
Record last verified: 2021-05