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NSS: SPD489 as Adjunctive Treatment in Adults With Negative Symptoms of Schizophrenia

Sponsor
Shire (Industry)
Overall Status
Withdrawn
CT.gov ID
NCT01234298
Collaborator
(none)
0
Enrollment
3
Arms
24.9
Anticipated Duration (Months)

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: SPD489 Low-Dose
  • Drug: SPD489 High-Dose
  • Drug: Placebo
 Phase 3

Study Design

Study Type:
Interventional
Actual Enrollment :
0 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
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
Anticipated Study Start Date :
Jan 27, 2012
Anticipated Primary Completion Date :
Feb 24, 2014
Anticipated Study Completion Date :
Feb 24, 2014

Arms and Interventions

Arm Intervention/Treatment
Experimental: SPD489 Low-Dose

Drug: SPD489 Low-Dose
SPD489 20, 30, or 40 mg capsules taken once-daily for up to 26 weeks
Other Names:
  • Vyvanse, Lisdexamfetamine dimesylate, LDX

    		•
    Experimental: SPD489 High-Dose

    Drug: SPD489 High-Dose
    SPD489 50, 60, or 70 mg capsules taken once-daily for up to 26 weeks
    Other Names:
  • Vyvanse, Lisdexamfetamine dimesylate, LDX

    		•
    Placebo Comparator: Placebo

    Drug: Placebo
    Placebo capsule taken once-daily for up to 26 weeks

    Outcome Measures

    Primary Outcome Measures

    1. Negative Symptom Assessment (NSA-16) total score [up to 26 weeks]

    Secondary Outcome Measures

    1. Positive and Negative Syndrome Scale (PANSS) [up to 26 weeks]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 55 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Shire

    Investigators

    • Study Director: Study Director, Takeda

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Shire
    ClinicalTrials.gov Identifier:
    NCT01234298
    Other Study ID Numbers:
    • SPD489-320
    First Posted:
    Nov 4, 2010
    Last Update Posted:
    Jun 3, 2021
    Last Verified:
    May 1, 2021
    Additional relevant MeSH terms:
    Schizophrenia
    Lisdexamfetamine Dimesylate

    Study Results

    No Results Posted as of Jun 3, 2021