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SPD489 Low Dose and High Dose Ranges 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 low dose range (40mg, 80mg, and 100mg)

SPD489 high dose range (120mg, 140mg and 160mg)

Placebo

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 days

Sites / Locations

Galiz Research
Psychiatric Care and Research Center
St. Charles Psychiatric Associates
CRI Lifetree

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Placebo Comparator

Arm Label

SPD489 Low Dose Range

SPD489 High Dose Range

Placebo

Arm Description

Outcomes

Primary Outcome Measures

Change From Baseline in Negative Symptom Assessment (NSA-16) Total Score at 26 Weeks

Secondary Outcome Measures

Change From Baseline in the Personal and Social Performance (PSP) Scale Score at 26 Weeks

Change From Baseline in Simpson Angus Scale (SAS) Total Score at 26 Weeks

Change From Baseline in Barnes Akathisia Scale (BAS) Total Score at 26 Weeks

Change From Baseline in the Abnormal Involuntary Movement Scale (AIMS) at 26 Weeks

Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Scores at 26 Weeks

Change From Baseline in Cognitive Test Battery (CogState Battery) Score at 26 Weeks

Change From Baseline in Social Functioning Scale (SFS) at 26 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 Amphetamine Cessation Symptom Assessment (ACSA) Total Score at 26 Weeks

Change From Baseline in Clinical Evaluation of Harmful Behavior (CEHB) Scale at 26 Weeks

Columbia-Suicide Severity Rating Scale (C-SSRS)

Change From Baseline in Calgary Depression Scale for Schizophrenia (CDSS) at 26 Weeks

Full Information

NCT ID

NCT01760889

First Posted

January 2, 2013

Last Updated

May 29, 2021

Sponsor

Shire

1. Study Identification

Unique Protocol Identification Number

NCT01760889

Brief Title

SPD489 Low Dose and High Dose Ranges When Added to Stable Doses of Antipsychotic Medications in Clinically Stable Adults With Negative Symptoms of Schizophrenia

Official Title

A Phase 3 Multicenter, Randomized, Double-blind, Parallel-group, Placebo-controlled, 26-week, Dose-optimization Study to Evaluate the Efficacy, Safety, and Tolerability of SPD489 Low Dose Range (40mg, 80mg, 100mg) and High Dose Range (120mg, 140mg, 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

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 whether SPD489 low dose range (40, 80, or 100mg) and high dose range (120, 140, or 160mg) are effective in the treatment of Negative Symptoms.

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

1 (Actual)

8. Arms, Groups, and Interventions

Arm Title

SPD489 Low Dose Range

Arm Type

Experimental

Arm Title

SPD489 High Dose Range

Arm Type

Experimental

Arm Title

Placebo

Arm Type

Placebo Comparator

Intervention Type

Drug

Intervention Name(s)

SPD489 low dose range (40mg, 80mg, and 100mg)

Other Intervention Name(s)

lisdexamfetamine dimesylate, LDX, Vyvanse

Intervention Description

Capsule, dose titration, 40 mg capsule once-daily for 1 week; then 80 mg capsule once-daily for 4 weeks; then, 100 mg capsule once-daily (if unable to tolerate 100 mg dose between weeks 5 to 6, then dose to be decreased to 80 mg once-daily for the remaining 21 weeks; if able to tolerate 100 mg dose then will continue on 100 mg capsule once-daily for 21 weeks

Intervention Type

Drug

Intervention Name(s)

SPD489 high dose range (120mg, 140mg and 160mg)

Other Intervention Name(s)

lisdexamfetamine dimesylate, LDX, Vyvanse

Intervention Description

Capsule, dose titration, 40 mg capsule once-daily for 1 week; then 80 mg capsule once daily for 1 week; then 120 mg capsule once-daily for 1 week, then, 140 mg capsule once-daily for 2 weeks, then 160 mg once capsule once-daily (if unable to tolerate 160 mg dose between weeks 5 to 6, then dose to be decreased to 140 mg once-daily for the remaining 21 weeks; if able to tolerate 160 mg dose then will continue on 160 mg capsule once-daily for 21 weeks

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

One capsule a day for 26 weeks

Primary Outcome Measure Information:

Title

Change From Baseline in Negative Symptom Assessment (NSA-16) Total Score at 26 Weeks

Time Frame

Baseline and 26 weeks

Secondary Outcome Measure Information:

Title

Change From Baseline in the Personal and Social Performance (PSP) Scale Score at 26 Weeks

Time Frame

Baseline and 26 weeks

Title

Change From Baseline in Simpson Angus Scale (SAS) Total Score at 26 Weeks

Time Frame

Baseline and 26 weeks

Title

Change From Baseline in Barnes Akathisia Scale (BAS) Total Score at 26 Weeks

Time Frame

Baseline and 26 weeks

Title

Change From Baseline in the Abnormal Involuntary Movement Scale (AIMS) at 26 Weeks

Time Frame

Baseline and 26 weeks

Title

Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Scores at 26 Weeks

Time Frame

Baseline and 26 weeks

Title

Change From Baseline in Cognitive Test Battery (CogState Battery) Score at 26 Weeks

Time Frame

Baseline and 26 weeks

Title

Change From Baseline in Social Functioning Scale (SFS) at 26 Weeks

Time Frame

Baseline and 26 weeks

Title

Clinical Global Impression-Schizophrenia Severity of Illness (CGI-SCH-S) Scale

Time Frame

Baseline and week 26

Title

Clinical Global Impression-Schizophrenia Degree of Change (CGI-SCH-C) Scale

Time Frame

Up to 26 weeks

Title

Change From Baseline in Amphetamine Cessation Symptom Assessment (ACSA) Total Score at 26 Weeks

Time Frame

Baseline and 26 weeks

Title

Change From Baseline in Clinical Evaluation of Harmful Behavior (CEHB) Scale at 26 Weeks

Time Frame

Baseline and 26 weeks

Title

Columbia-Suicide Severity Rating Scale (C-SSRS)

Time Frame

Up to 26 weeks

Title

Change From Baseline in Calgary Depression Scale for Schizophrenia (CDSS) at 26 Weeks

Time Frame

Baseline and 26 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

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

Galiz Research

City

Miami Springs

State/Province

Florida

ZIP/Postal Code

33166

Country

United States

Facility Name

Psychiatric Care and Research Center

City

O'Fallon

State/Province

Missouri

ZIP/Postal Code

63368

Country

United States

Facility Name

St. Charles Psychiatric Associates

City

Saint Charles

State/Province

Missouri

ZIP/Postal Code

63304

Country

United States

Facility Name

CRI Lifetree

City

Philadelphia

State/Province

Pennsylvania

ZIP/Postal Code

19139

Country

United States

12. IPD Sharing Statement

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SPD489 Low Dose and High Dose Ranges When Added to Stable Doses of Antipsychotic Medications in Clinically Stable Adults With Negative Symptoms of Schizophrenia

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