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

Purpose

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.

Condition	Intervention	Phase
Schizophrenia	Drug: SPD489 low dose range (40mg, 80mg, and 100mg) Drug: SPD489 high dose range (120mg, 140mg and 160mg) Drug: Placebo	Phase 3


Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment
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

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 Negative Symptom Assessment (NSA-16) Total Score at 26 Weeks [ Time Frame: Baseline and 26 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Change From Baseline in the Personal and Social Performance (PSP) Scale Score at 26 Weeks [ Time Frame: Baseline and 26 weeks ] [ Designated as safety issue: No ]
Change From Baseline in Simpson Angus Scale (SAS) Total Score at 26 Weeks [ Time Frame: Baseline and 26 weeks ] [ Designated as safety issue: Yes ]
Change From Baseline in Barnes Akathisia Scale (BAS) Total Score at 26 Weeks [ Time Frame: Baseline and 26 weeks ] [ Designated as safety issue: Yes ]
Change From Baseline in the Abnormal Involuntary Movement Scale (AIMS) at 26 Weeks [ Time Frame: Baseline and 26 weeks ] [ Designated as safety issue: Yes ]
Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Scores at 26 Weeks [ Time Frame: Baseline and 26 weeks ] [ Designated as safety issue: No ]
Change From Baseline in Cognitive Test Battery (CogState Battery) Score at 26 Weeks [ Time Frame: Baseline and 26 weeks ] [ Designated as safety issue: No ]
Change From Baseline in Social Functioning Scale (SFS) at 26 Weeks [ Time Frame: Baseline and 26 weeks ] [ Designated as safety issue: No ]
Clinical Global Impression-Schizophrenia Severity of Illness (CGI-SCH-S) Scale [ Time Frame: Baseline and week 26 ] [ Designated as safety issue: No ]
Clinical Global Impression-Schizophrenia Degree of Change (CGI-SCH-C) Scale [ Time Frame: Up to 26 weeks ] [ Designated as safety issue: No ]
Change From Baseline in Amphetamine Cessation Symptom Assessment (ACSA) Total Score at 26 Weeks [ Time Frame: Baseline and 26 weeks ] [ Designated as safety issue: Yes ]
Change From Baseline in Clinical Evaluation of Harmful Behavior (CEHB) Scale at 26 Weeks [ Time Frame: Baseline and 26 weeks ] [ Designated as safety issue: Yes ]
Columbia-Suicide Severity Rating Scale (C-SSRS) [ Time Frame: Up to 26 weeks ] [ Designated as safety issue: Yes ]
Change From Baseline in Calgary Depression Scale for Schizophrenia (CDSS) at 26 Weeks [ Time Frame: Baseline and 26 weeks ] [ Designated as safety issue: Yes ]


Enrollment:	1
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 Low Dose Range	Drug: SPD489 low dose range (40mg, 80mg, and 100mg) 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 Other Name: lisdexamfetamine dimesylate, LDX, Vyvanse
Experimental: SPD489 High Dose Range	Drug: SPD489 high dose range (120mg, 140mg and 160mg) 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 Other Name: lisdexamfetamine dimesylate, LDX, Vyvanse
Placebo Comparator: Placebo	Drug: Placebo One capsule a day for 26 weeks

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: NCT01760889

Locations


United States, Florida
Galiz Research
Miami Springs, Florida, United States, 33166
United States, Missouri
Psychiatric Care and Research Center
O'Fallon, Missouri, United States, 63368
St. Charles Psychiatric Associates
St. Charles, Missouri, United States, 63304
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 Semel Institute for Neuroscience at UCLA

More Information

No publications provided


Responsible Party:	Shire
ClinicalTrials.gov Identifier:	NCT01760889 History of Changes
Other Study ID Numbers:	SPD489-335, 2012-003919-57
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

Additional relevant MeSH terms:


Schizophrenia Mental Disorders Schizophrenia and Disorders with Psychotic Features Dextroamphetamine Central Nervous System Agents Central Nervous System Stimulants Dopamine Agents	Dopamine Uptake Inhibitors Molecular Mechanisms of Pharmacological Action Neurotransmitter Agents Neurotransmitter Uptake Inhibitors Pharmacologic Actions Physiological Effects of Drugs Therapeutic Uses

ClinicalTrials.gov processed this record on March 03, 2015