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Adjunctive SPD489 to Antipsychotic Medication in Clinically Stable Adults With Persistent Predominant Negative Symptoms of Schizophrenia

Primary Purpose

Schizophrenia

Status
Terminated
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
SPD489 40mg
SPD489 100mg
SPD489 160mg
Placebo
Sponsored by
Shire
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Schizophrenia

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 day

Sites / Locations

  • University Hills Clinical Research

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Placebo Comparator

Arm Label

SPD489 40mg

SPD489 100mg

SPD489 160mg

Placebo

Arm Description

Outcomes

Primary Outcome Measures

Change From Baseline in Negative Symptom Assessment - 16-item (NSA-16) Total Score at 12 Weeks

Secondary Outcome Measures

Change From Baseline in the Personal and Social Performance Scale (PSP) Score at 12 Weeks
Change From Baseline in Simpson Angus Scale (SAS) Total Score at 12 Weeks
Change From Baseline in Barnes Akathisia Scale (BAS) Total Score at 12 Weeks
Change From Baseline in Amphetamine Cessation Symptom Assessment (ACSA) Total Score at 12 Weeks
Change From Baseline in the Abnormal Involuntary Movement Scale (AIMS) at 12 Weeks
Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Scores at 12 Weeks
Change From Baseline in Cognitive Test Battery (CogState Battery) Score at 12 Weeks
Change From Baseline in Social Functioning Scale (SFS) at 12 Weeks
Change From Baseline in Clinical Evaluation of Harmful Behavior (CEHB) Scale at 12 Weeks
Clinical Global Impression-Schizophrenia Severity of Illness (CGI-SCH-S) Scale
Clinical Global Impression-Schizophrenia Degree of Change (CGI-SCH-C) Scale
Columbia-Suicide Severity Rating Scale (C-SSRS)
Change From Baseline in Calgary Depression Scale for Schizophrenia (CDSS) at 12 Weeks
Ambulatory Blood Pressure Monitoring (ABPM)

Full Information

First Posted
November 28, 2012
Last Updated
May 29, 2021
Sponsor
Shire
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1. Study Identification

Unique Protocol Identification Number
NCT01738698
Brief Title
Adjunctive SPD489 to Antipsychotic Medication in Clinically Stable Adults With Persistent Predominant Negative Symptoms of Schizophrenia
Official Title
A Phase 3 Multicenter, Randomized, Double-blind, Parallel-group, Placebo-controlled, 12-week, Forced-dose Titration Study to Evaluate the Efficacy, Safety, and Tolerability of SPD489 40mg, 100mg, or 160mg 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
November 1, 2012 (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 whether SPD489 40 mg, 100 mg, and 160 mg are effective and safe in the treatment of Negative Symptoms of Schizophrenia (NSS).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizophrenia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
4 (Actual)

8. Arms, Groups, and Interventions

Arm Title
SPD489 40mg
Arm Type
Experimental
Arm Title
SPD489 100mg
Arm Type
Experimental
Arm Title
SPD489 160mg
Arm Type
Experimental
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
SPD489 40mg
Other Intervention Name(s)
lisdexamfetamine dimesylate, LDX, Vyvanse
Intervention Description
Oral administration of 40 mg once-daily for up to 12 weeks
Intervention Type
Drug
Intervention Name(s)
SPD489 100mg
Other Intervention Name(s)
lisdexamfetamine dimesylate, LDX, Vyvanse
Intervention Description
Oral administration of 100 mg once-daily for up to 12 weeks
Intervention Type
Drug
Intervention Name(s)
SPD489 160mg
Other Intervention Name(s)
lisdexamfetamine dimesylate, LDX, Vyvanse
Intervention Description
Oral administration of 160 mg once-daily for up to 12 weeks
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Oral administration once-daily for 12 weeks
Primary Outcome Measure Information:
Title
Change From Baseline in Negative Symptom Assessment - 16-item (NSA-16) Total Score at 12 Weeks
Time Frame
Baseline and 12 weeks
Secondary Outcome Measure Information:
Title
Change From Baseline in the Personal and Social Performance Scale (PSP) Score at 12 Weeks
Time Frame
Baseline and 12 weeks
Title
Change From Baseline in Simpson Angus Scale (SAS) Total Score at 12 Weeks
Time Frame
Baseline and 12 weeks
Title
Change From Baseline in Barnes Akathisia Scale (BAS) Total Score at 12 Weeks
Time Frame
Baseline and 12 weeks
Title
Change From Baseline in Amphetamine Cessation Symptom Assessment (ACSA) Total Score at 12 Weeks
Time Frame
Baseline and 12 weeks
Title
Change From Baseline in the Abnormal Involuntary Movement Scale (AIMS) at 12 Weeks
Time Frame
Baseline and 12 weeks
Title
Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Scores at 12 Weeks
Time Frame
Baseline and 12 weeks
Title
Change From Baseline in Cognitive Test Battery (CogState Battery) Score at 12 Weeks
Time Frame
Baseline and 12 weeks
Title
Change From Baseline in Social Functioning Scale (SFS) at 12 Weeks
Time Frame
Baseline and 12 weeks
Title
Change From Baseline in Clinical Evaluation of Harmful Behavior (CEHB) Scale at 12 Weeks
Time Frame
Baseline and 12 weeks
Title
Clinical Global Impression-Schizophrenia Severity of Illness (CGI-SCH-S) Scale
Time Frame
Baseline and week 12
Title
Clinical Global Impression-Schizophrenia Degree of Change (CGI-SCH-C) Scale
Time Frame
Up to 12 weeks
Title
Columbia-Suicide Severity Rating Scale (C-SSRS)
Time Frame
Up to 12 weeks
Title
Change From Baseline in Calgary Depression Scale for Schizophrenia (CDSS) at 12 Weeks
Time Frame
Baseline and 12 weeks
Title
Ambulatory Blood Pressure Monitoring (ABPM)
Time Frame
Baseline and Weeks 4 and 10

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 day
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Study Director
Organizational Affiliation
Takeda
Official's Role
Study Director
Facility Information:
Facility Name
University Hills Clinical Research
City
Irving
State/Province
Texas
ZIP/Postal Code
75062
Country
United States

12. IPD Sharing Statement

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Adjunctive SPD489 to Antipsychotic Medication in Clinically Stable Adults With Persistent Predominant Negative Symptoms of Schizophrenia

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