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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

Primary Purpose

Schizophrenia

Status
Terminated
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
SPD489
Sponsored by
Shire
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Schizophrenia focused on measuring Not Required

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • SP Research PLLC/Oklahoma Clinical Research Center
  • CRI Lifetree

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

SPD489

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Change From Baseline in Negative Symptom Assessment (NSA-16) Total Score at 52 Weeks
Change From Baseline in the Personal and Social Performance (PSP) Scale Score at 52 Weeks
Clinical Global Impression-Schizophrenia Severity of Illness (CGI-SCH-S) Scale
Clinical Global Impression-Schizophrenia Degree of Change (CGI-SCH-C) Scale
Change From Baseline in Social Functioning Scale (SFS) at 52 Weeks

Full Information

First Posted
January 2, 2013
Last Updated
May 29, 2021
Sponsor
Shire
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1. Study Identification

Unique Protocol Identification Number
NCT01760993
Brief Title
Long-term Safety of SPD489 When Added to Stable Doses of Antipsychotic Medications in Clinically Stable Adults With Negative Symptoms of Schizophrenia
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
Study Type
Interventional

2. Study Status

Record Verification Date
May 2021
Overall Recruitment Status
Terminated
Why Stopped
Study was discontinued due to non-safety related business prioritization decisions. No subjects were randomized.
Study Start Date
February 1, 2013 (Actual)
Primary Completion Date
April 1, 2013 (Actual)
Study Completion Date
April 1, 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Shire

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
Detailed Description
Not required

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizophrenia
Keywords
Not Required

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
2 (Actual)

8. Arms, Groups, and Interventions

Arm Title
SPD489
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
SPD489
Other Intervention Name(s)
lisdexamfetamine dimesylate, LDX, Vyvanse
Intervention Description
Once-daily oral optimized doses of SPD489 (either 40 mg, 80 mg, 100 mg, 120 mg, 140 mg, or 160 mg) for 52 weeks
Primary Outcome Measure Information:
Title
Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Scores at 52 Weeks
Time Frame
Basline and 52 weeks
Title
Change From Baseline in Cognitive Test Battery (CogState Battery) Score at 52 Weeks
Time Frame
Baseline and 52 weeks
Title
Columbia-Suicide Severity Rating Scale (C-SSRS)
Time Frame
Up to 52 weeks
Title
Change From Baseline in Calgary Depression Scale for Schizophrenia (CDSS) at 52 Weeks
Time Frame
Baseline and 52 weeks
Title
Change From Baseline in Simpson Angus Scale (SAS) Total Score at 52 Weeks
Time Frame
Baseline and 52 weeks
Title
Change From Baseline in Barnes Akathisia Scale (BAS) Total Score at 52 Weeks
Time Frame
Baseline and 52 weeks
Title
Change From Baseline in the Abnormal Involuntary Movement Scale (AIMS) at 52 Weeks
Time Frame
Baseline and 52 weeks
Title
Change From Baseline in Clinical Evaluation of Harmful Behavior (CEHB) Scale at 52 Weeks
Time Frame
Baseline and 52 weeks
Title
Change From Baseline in Amphetamine Cessation Symptom Assessment (ACSA) Total Score at 52 Weeks
Time Frame
Baseline and 52 weeks
Secondary Outcome Measure Information:
Title
Change From Baseline in Negative Symptom Assessment (NSA-16) Total Score at 52 Weeks
Time Frame
Baseline and 52 weeks
Title
Change From Baseline in the Personal and Social Performance (PSP) Scale Score at 52 Weeks
Time Frame
Baseline and 52 weeks
Title
Clinical Global Impression-Schizophrenia Severity of Illness (CGI-SCH-S) Scale
Time Frame
Baseline and week 52
Title
Clinical Global Impression-Schizophrenia Degree of Change (CGI-SCH-C) Scale
Time Frame
Up to 52 weeks
Title
Change From Baseline in Social Functioning Scale (SFS) at 52 Weeks
Time Frame
Baseline and 52 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Study Director
Organizational Affiliation
Takeda
Official's Role
Study Director
Facility Information:
Facility Name
SP Research PLLC/Oklahoma Clinical Research Center
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73112
Country
United States
Facility Name
CRI Lifetree
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19139
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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