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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01234298
Recruitment Status : Withdrawn (Study was discontinued due to non-safety related business prioritization decisions)
First Posted : November 4, 2010
Last Update Posted : March 14, 2012
Information provided by (Responsible Party):

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
Negative Symptoms of Schizophrenia Drug: SPD489 Low-Dose Drug: SPD489 High-Dose Drug: Placebo Phase 3

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Study Type : Interventional  (Clinical Trial)
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
Study Start Date : January 2012
Estimated Primary Completion Date : February 2014
Estimated Study Completion Date : February 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Schizophrenia

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 Name: 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 Name: Vyvanse, Lisdexamfetamine dimesylate, LDX

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

Primary Outcome Measures :
  1. Negative Symptom Assessment (NSA-16) total score [ Time Frame: up to 26 weeks ]

Secondary Outcome Measures :
  1. Positive and Negative Syndrome Scale (PANSS) [ Time Frame: up to 26 weeks ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
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

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Responsible Party: Shire Identifier: NCT01234298     History of Changes
Other Study ID Numbers: SPD489-320
First Posted: November 4, 2010    Key Record Dates
Last Update Posted: March 14, 2012
Last Verified: September 2011
Additional relevant MeSH terms:
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Lisdexamfetamine Dimesylate
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders
Central Nervous System Stimulants
Physiological Effects of Drugs
Dopamine Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Dopamine Agents
Neurotransmitter Agents