Back to resultsSPD489 as Adjunctive Treatment in Adults With Negative Symptoms of Schizophrenia (NSS)
Primary Purpose
Negative Symptoms of Schizophrenia
Status
Withdrawn
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
SPD489 Low-Dose
SPD489 High-Dose
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Negative Symptoms of Schizophrenia
Eligibility Criteria
Inclusion Criteria:
- Subject has diagnosis of schizophrenia for at least 2 years
- Subject has persistent predominant negative symptoms
- Subject has 2 or more persistent predominant negative symptoms (affective flattening, alogia, avolition apathy, and anhedonia-asociality) determined to have been present for at least 6 months
- Subject is maintained on antipsychotic monotherapy or polytherapy with no more than 2 antipsychotic medications
- Subject has been clinically stable and is in the non-acute phase of illness
Exclusion Criteria:
- Subject has clinically notable positive symptoms
- Subject is considered to be treatment refractory
- Subject has current history of substance abuse/dependance
- Subject is considered a suicide risk or risk to harm others
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Placebo Comparator
Arm Label
SPD489 Low-Dose
SPD489 High-Dose
Placebo
Arm Description
Outcomes
Primary Outcome Measures
Negative Symptom Assessment (NSA-16) total score
Secondary Outcome Measures
Positive and Negative Syndrome Scale (PANSS)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01234298
Brief Title
SPD489 as Adjunctive Treatment in Adults With Negative Symptoms of Schizophrenia
Acronym
NSS
Official Title
A Phase 3 Multicenter, Randomized, Double-blind, Parallel-group, Placebo-controlled Study to Evaluate the Efficacy, Safety, and Tolerability of Low- and High-dose Range Groups of SPD489 as Adjunctive Treatment to Established Maintenance Doses of Antipsychotic Medications on Negative Symptoms in Clinically Stable Adults Who Have Persistent Predominant Negative Symptoms of Schizophrenia
Study Type
Interventional
2. Study Status
Record Verification Date
May 2021
Overall Recruitment Status
Withdrawn
Why Stopped
Study was discontinued due to non-safety related business prioritization decisions
Study Start Date
January 27, 2012 (Anticipated)
Primary Completion Date
February 24, 2014 (Anticipated)
Study Completion Date
February 24, 2014 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Shire
4. Oversight
5. Study Description
Brief Summary
To assess the safety and efficacy of SPD489 low-dose and high-dose treatment groups to placebo when given as adjunctive therapy to antipsychotic medication in clinically stable adults with persistent predominant negative symptoms of schizophrenia.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Negative Symptoms of Schizophrenia
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
SPD489 Low-Dose
Arm Type
Experimental
Arm Title
SPD489 High-Dose
Arm Type
Experimental
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
SPD489 Low-Dose
Other Intervention Name(s)
Vyvanse, Lisdexamfetamine dimesylate, LDX
Intervention Description
SPD489 20, 30, or 40 mg capsules taken once-daily for up to 26 weeks
Intervention Type
Drug
Intervention Name(s)
SPD489 High-Dose
Other Intervention Name(s)
Vyvanse, Lisdexamfetamine dimesylate, LDX
Intervention Description
SPD489 50, 60, or 70 mg capsules taken once-daily for up to 26 weeks
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo capsule taken once-daily for up to 26 weeks
Primary Outcome Measure Information:
Title
Negative Symptom Assessment (NSA-16) total score
Time Frame
up to 26 weeks
Secondary Outcome Measure Information:
Title
Positive and Negative Syndrome Scale (PANSS)
Time Frame
up to 26 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Subject has diagnosis of schizophrenia for at least 2 years
Subject has persistent predominant negative symptoms
Subject has 2 or more persistent predominant negative symptoms (affective flattening, alogia, avolition apathy, and anhedonia-asociality) determined to have been present for at least 6 months
Subject is maintained on antipsychotic monotherapy or polytherapy with no more than 2 antipsychotic medications
Subject has been clinically stable and is in the non-acute phase of illness
Exclusion Criteria:
Subject has clinically notable positive symptoms
Subject is considered to be treatment refractory
Subject has current history of substance abuse/dependance
Subject is considered a suicide risk or risk to harm others
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Study Director
Organizational Affiliation
Takeda
Official's Role
Study Director
12. IPD Sharing Statement
Learn more about this trial
SPD489 as Adjunctive Treatment in Adults With Negative Symptoms of Schizophrenia
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