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Long-term Safety of SPD489 When Added to Stable Doses of Antipsychotic Medications in Clinically Stable Adults With Negative Symptoms of Schizophrenia

This study has been terminated.
(Study was discontinued due to non-safety related business prioritization decisions. No subjects were randomized.)
Sponsor:
ClinicalTrials.gov Identifier:
NCT01760993
First Posted: January 4, 2013
Last Update Posted: May 29, 2014
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.
Information provided by (Responsible Party):
Shire
  Purpose
The primary purpose of this study is to determine if the long-term use of SPD489 (40, 80, 100, 120, 140, and 160mg) administered as a daily morning is safe and tolerable.

Condition Intervention Phase
Schizophrenia Drug: SPD489 Phase 3

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 3, Long-term, Open-label, Multicenter, 52-week, Flexible-dose Safety Study 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:

Primary Outcome Measures:
  • Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Scores at 52 Weeks [ Time Frame: Basline and 52 weeks ]
  • Change From Baseline in Cognitive Test Battery (CogState Battery) Score at 52 Weeks [ Time Frame: Baseline and 52 weeks ]
  • Columbia-Suicide Severity Rating Scale (C-SSRS) [ Time Frame: Up to 52 weeks ]
  • Change From Baseline in Calgary Depression Scale for Schizophrenia (CDSS) at 52 Weeks [ Time Frame: Baseline and 52 weeks ]
  • Change From Baseline in Simpson Angus Scale (SAS) Total Score at 52 Weeks [ Time Frame: Baseline and 52 weeks ]
  • Change From Baseline in Barnes Akathisia Scale (BAS) Total Score at 52 Weeks [ Time Frame: Baseline and 52 weeks ]
  • Change From Baseline in the Abnormal Involuntary Movement Scale (AIMS) at 52 Weeks [ Time Frame: Baseline and 52 weeks ]
  • Change From Baseline in Clinical Evaluation of Harmful Behavior (CEHB) Scale at 52 Weeks [ Time Frame: Baseline and 52 weeks ]
  • Change From Baseline in Amphetamine Cessation Symptom Assessment (ACSA) Total Score at 52 Weeks [ Time Frame: Baseline and 52 weeks ]

Secondary Outcome Measures:
  • Change From Baseline in Negative Symptom Assessment (NSA-16) Total Score at 52 Weeks [ Time Frame: Baseline and 52 weeks ]
  • Change From Baseline in the Personal and Social Performance (PSP) Scale Score at 52 Weeks [ Time Frame: Baseline and 52 weeks ]
  • Clinical Global Impression-Schizophrenia Severity of Illness (CGI-SCH-S) Scale [ Time Frame: Baseline and week 52 ]
  • Clinical Global Impression-Schizophrenia Degree of Change (CGI-SCH-C) Scale [ Time Frame: Up to 52 weeks ]
  • Change From Baseline in Social Functioning Scale (SFS) at 52 Weeks [ Time Frame: Baseline and 52 weeks ]
Enrollment: 2
Study Start Date: February 2013
Study Completion Date: April 2013
Primary Completion Date: April 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: SPD489 Drug: SPD489
Once-daily oral optimized doses of SPD489 (either 40 mg, 80 mg, 100 mg, 120 mg, 140 mg, or 160 mg) for 52 weeks
Other Name: lisdexamfetamine dimesylate, LDX, Vyvanse

Detailed Description:
Not required
  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 18 to 65 years of age
  • Has a reliable informant (eg, family member, social worker, caseworker, or nurse that spends >4 hours/week with the subject)
  • Fixed home/place of residence and can be reached by telephone
  • On a stable dose of antipsychotic medications
  • Able to swallow capsules

Exclusion Criteria:

  • -Taking lithium, carbamazepine, lamotrigine, gabapentin, cholinesterase inhibitors, modafinil, or other stimulants such as methylphenidate and other amphetamine products
  • Treated with clozapine in past 30 days
  • Lifetime history of stimulant, cocaine, or amphetamine abuse or dependence
  • History of seizures (other than infantile febrile seizures), any tic disorder, or current diagnosis and/or a known family history of Tourette's Disorder, serious neurological disease, history of significant head trauma, dementia, cerebrovascular disease, Parkinson's disease, or intracranial lesions
  • Uncontrolled hypertension
  • History of thyroid disorder that has not been stabilized on thyroid medication
  • Glaucoma
  • Pregnant or nursing
  • Subject has received an investigational product or participated in a clinical study within 30 days
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01760993


Locations
United States, Oklahoma
SP Research PLLC/Oklahoma Clinical Research Center
Oklahoma City, Oklahoma, United States, 73112
United States, Pennsylvania
CRI Lifetree
Philadelphia, Pennsylvania, United States, 19139
Sponsors and Collaborators
Shire
Investigators
Principal Investigator: Stephen R. Marder, MD Desert Pacific Mental Illness Research, Education, and Clinical Center
  More Information

Responsible Party: Shire
ClinicalTrials.gov Identifier: NCT01760993     History of Changes
Other Study ID Numbers: SPD489-336
2012-003920-18 ( EudraCT Number )
First Submitted: January 2, 2013
First Posted: January 4, 2013
Results First Submitted: May 1, 2014
Results First Posted: May 29, 2014
Last Update Posted: May 29, 2014
Last Verified: May 2014

Keywords provided by Shire:
Not Required

Additional relevant MeSH terms:
Schizophrenia
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders
Antipsychotic Agents
Lisdexamfetamine Dimesylate
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
 Psychotropic Drugs
Central Nervous System Stimulants
Dopamine Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Dopamine Agents
Neurotransmitter Agents