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

• ClinicalTrials.gov Identifier: NCT01760993
• Recruitment Status: Terminated
• First Posted: January 4, 2013
• Results First Posted: May 29, 2014
• Last Update Posted: May 29, 2014
• Sponsor: Shire
• Information provided by (Responsible Party): Shire

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.

Condition or disease	Intervention/treatment	Phase
Schizophrenia	Drug: SPD489	Phase 3

Detailed Description:

Not required

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 2 participants
• Intervention Model: Single Group Assignment
• Masking: None (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
• Study Start Date: February 2013
• Actual Primary Completion Date: April 2013
• Actual Study Completion Date: April 2013

Arms and Interventions

Arm	Intervention/treatment
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

Outcome Measures

Primary Outcome Measures :

1. Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Scores at 52 Weeks [ Time Frame: Basline and 52 weeks ]
2. Change From Baseline in Cognitive Test Battery (CogState Battery) Score at 52 Weeks [ Time Frame: Baseline and 52 weeks ]
3. Columbia-Suicide Severity Rating Scale (C-SSRS) [ Time Frame: Up to 52 weeks ]
4. Change From Baseline in Calgary Depression Scale for Schizophrenia (CDSS) at 52 Weeks [ Time Frame: Baseline and 52 weeks ]
5. Change From Baseline in Simpson Angus Scale (SAS) Total Score at 52 Weeks [ Time Frame: Baseline and 52 weeks ]
6. Change From Baseline in Barnes Akathisia Scale (BAS) Total Score at 52 Weeks [ Time Frame: Baseline and 52 weeks ]
7. Change From Baseline in the Abnormal Involuntary Movement Scale (AIMS) at 52 Weeks [ Time Frame: Baseline and 52 weeks ]
8. Change From Baseline in Clinical Evaluation of Harmful Behavior (CEHB) Scale at 52 Weeks [ Time Frame: Baseline and 52 weeks ]
9. Change From Baseline in Amphetamine Cessation Symptom Assessment (ACSA) Total Score at 52 Weeks [ Time Frame: Baseline and 52 weeks ]

Secondary Outcome Measures :

1. Change From Baseline in Negative Symptom Assessment (NSA-16) Total Score at 52 Weeks [ Time Frame: Baseline and 52 weeks ]
2. Change From Baseline in the Personal and Social Performance (PSP) Scale Score at 52 Weeks [ Time Frame: Baseline and 52 weeks ]
3. Clinical Global Impression-Schizophrenia Severity of Illness (CGI-SCH-S) Scale [ Time Frame: Baseline and week 52 ]
4. Clinical Global Impression-Schizophrenia Degree of Change (CGI-SCH-C) Scale [ Time Frame: Up to 52 weeks ]
5. Change From Baseline in Social Functioning Scale (SFS) at 52 Weeks [ Time Frame: Baseline and 52 weeks ]

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 65 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• 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

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

• Responsible Party: Shire
• ClinicalTrials.gov Identifier: NCT01760993 History of Changes
• Other Study ID Numbers: SPD489-336; 2012-003920-18 ( EudraCT Number )
• First Posted: January 4, 2013
• Results First Posted: May 29, 2014
• Last Update Posted: May 29, 2014
• Last Verified: May 2014

Keywords provided by Shire:

Not Required

Additional relevant MeSH terms:

Schizophrenia; Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders; Antipsychotic Agents; Lisdexamfetamine Dimesylate; Tranquilizing Agents; Central Nervous System Depressants; Physiological Effects of Drugs; Psychotropic Drugs; Central Nervous System Stimulants; Dopamine Uptake Inhibitors; Neurotransmitter Uptake Inhibitors; Membrane Transport Modulators; Molecular Mechanisms of Pharmacological Action; Dopamine Agents; Neurotransmitter Agents