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

This study has been withdrawn prior to enrollment.
(Study was discontinued due to non-safety related business prioritization decisions)
Sponsor:
Information provided by (Responsible Party):
Shire Development LLC
ClinicalTrials.gov Identifier:
NCT01234298
First received: October 29, 2010
Last updated: March 13, 2012
Last verified: September 2011
History of Changes
  Purpose

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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:

MedlinePlus related topics: Schizophrenia
U.S. FDA Resources

Further study details as provided by Shire Development LLC:

Primary Outcome Measures:
  • Negative Symptom Assessment (NSA-16) total score [ Time Frame: up to 26 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Positive and Negative Syndrome Scale (PANSS) [ Time Frame: up to 26 weeks ] [ Designated as safety issue: Yes ]

Enrollment: 0
Study Start Date: January 2012
Estimated Study Completion Date: February 2014
Estimated Primary Completion Date: February 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: Shire Development LLC
ClinicalTrials.gov Identifier: NCT01234298     History of Changes
Other Study ID Numbers: SPD489-320
Study First Received: October 29, 2010
Last Updated: March 13, 2012
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Schizophrenia
Schizophrenia and Disorders with Psychotic Features
Mental Disorders
Dextroamphetamine
Dopamine Uptake Inhibitors
Dopamine Agents
Neurotransmitter Agents
 Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Neurotransmitter Uptake Inhibitors
Physiological Effects of Drugs
Central Nervous System Stimulants
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 22, 2013