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:
Information provided by (Responsible Party):
Shire
ClinicalTrials.gov Identifier:
NCT01760993
First received: January 2, 2013
Last updated: May 1, 2014
Last verified: May 2014
  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: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: 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:


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 ] [ Designated as safety issue: No ]
  • Change From Baseline in Cognitive Test Battery (CogState Battery) Score at 52 Weeks [ Time Frame: Baseline and 52 weeks ] [ Designated as safety issue: No ]
  • Columbia-Suicide Severity Rating Scale (C-SSRS) [ Time Frame: Up to 52 weeks ] [ Designated as safety issue: Yes ]
  • Change From Baseline in Calgary Depression Scale for Schizophrenia (CDSS) at 52 Weeks [ Time Frame: Baseline and 52 weeks ] [ Designated as safety issue: Yes ]
  • Change From Baseline in Simpson Angus Scale (SAS) Total Score at 52 Weeks [ Time Frame: Baseline and 52 weeks ] [ Designated as safety issue: Yes ]
  • Change From Baseline in Barnes Akathisia Scale (BAS) Total Score at 52 Weeks [ Time Frame: Baseline and 52 weeks ] [ Designated as safety issue: Yes ]
  • Change From Baseline in the Abnormal Involuntary Movement Scale (AIMS) at 52 Weeks [ Time Frame: Baseline and 52 weeks ] [ Designated as safety issue: Yes ]
  • Change From Baseline in Clinical Evaluation of Harmful Behavior (CEHB) Scale at 52 Weeks [ Time Frame: Baseline and 52 weeks ] [ Designated as safety issue: Yes ]
  • Change From Baseline in Amphetamine Cessation Symptom Assessment (ACSA) Total Score at 52 Weeks [ Time Frame: Baseline and 52 weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Change From Baseline in Negative Symptom Assessment (NSA-16) Total Score at 52 Weeks [ Time Frame: Baseline and 52 weeks ] [ Designated as safety issue: No ]
  • Change From Baseline in the Personal and Social Performance (PSP) Scale Score at 52 Weeks [ Time Frame: Baseline and 52 weeks ] [ Designated as safety issue: No ]
  • Clinical Global Impression-Schizophrenia Severity of Illness (CGI-SCH-S) Scale [ Time Frame: Baseline and week 52 ] [ Designated as safety issue: No ]
  • Clinical Global Impression-Schizophrenia Degree of Change (CGI-SCH-C) Scale [ Time Frame: Up to 52 weeks ] [ Designated as safety issue: No ]
  • Change From Baseline in Social Functioning Scale (SFS) at 52 Weeks [ Time Frame: Baseline and 52 weeks ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Shire
ClinicalTrials.gov Identifier: NCT01760993     History of Changes
Other Study ID Numbers: SPD489-336, 2012-003920-18
Study First Received: January 2, 2013
Results First Received: May 1, 2014
Last Updated: May 1, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Shire:
Not Required

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

ClinicalTrials.gov processed this record on August 01, 2014