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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
This study has been terminated.
(Study was discontinued due to non-safety related business prioritization decisions. No subjects were randomized.)
Sponsor:
Shire
Information provided by (Responsible Party):
Shire
ClinicalTrials.gov Identifier:
NCT01760993
First received: January 2, 2013
Last updated: May 1, 2014
Last verified: May 2014
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Purpose
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 | Intervention | Phase |
|---|---|---|
| Schizophrenia | Drug: SPD489 | Phase 3 |
| Study Type: | Interventional |
| Study Design: | Intervention Model: Single Group Assignment Masking: 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 |
Resource links provided by NLM:
Genetics Home Reference related topics:
schizophrenia
MedlinePlus related topics:
Schizophrenia
Drug Information available for:
Lisdexamfetamine dimesylate
U.S. FDA Resources
Further study details as provided by Shire:
Primary Outcome Measures:
- Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Scores at 52 Weeks [ Time Frame: Basline and 52 weeks ]
- Change From Baseline in Cognitive Test Battery (CogState Battery) Score at 52 Weeks [ Time Frame: Baseline and 52 weeks ]
- Columbia-Suicide Severity Rating Scale (C-SSRS) [ Time Frame: Up to 52 weeks ]
- Change From Baseline in Calgary Depression Scale for Schizophrenia (CDSS) at 52 Weeks [ Time Frame: Baseline and 52 weeks ]
- Change From Baseline in Simpson Angus Scale (SAS) Total Score at 52 Weeks [ Time Frame: Baseline and 52 weeks ]
- Change From Baseline in Barnes Akathisia Scale (BAS) Total Score at 52 Weeks [ Time Frame: Baseline and 52 weeks ]
- Change From Baseline in the Abnormal Involuntary Movement Scale (AIMS) at 52 Weeks [ Time Frame: Baseline and 52 weeks ]
- Change From Baseline in Clinical Evaluation of Harmful Behavior (CEHB) Scale at 52 Weeks [ Time Frame: Baseline and 52 weeks ]
- Change From Baseline in Amphetamine Cessation Symptom Assessment (ACSA) Total Score at 52 Weeks [ Time Frame: Baseline and 52 weeks ]
Secondary Outcome Measures:
- Change From Baseline in Negative Symptom Assessment (NSA-16) Total Score at 52 Weeks [ Time Frame: Baseline and 52 weeks ]
- Change From Baseline in the Personal and Social Performance (PSP) Scale Score at 52 Weeks [ Time Frame: Baseline and 52 weeks ]
- Clinical Global Impression-Schizophrenia Severity of Illness (CGI-SCH-S) Scale [ Time Frame: Baseline and week 52 ]
- Clinical Global Impression-Schizophrenia Degree of Change (CGI-SCH-C) Scale [ Time Frame: Up to 52 weeks ]
- Change From Baseline in Social Functioning Scale (SFS) at 52 Weeks [ Time Frame: Baseline and 52 weeks ]
| Enrollment: | 2 |
| 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 |
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
|
Detailed Description:
Not required
Eligibility| Ages Eligible for Study: | 18 Years to 65 Years (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
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: NCT01760993
Please refer to this study by its ClinicalTrials.gov identifier: NCT01760993
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 ) |
| Study First Received: | January 2, 2013 |
| Results First Received: | May 1, 2014 |
| Last Updated: | May 1, 2014 |
Keywords provided by Shire:
|
Not Required |
Additional relevant MeSH terms:
|
Schizophrenia Schizophrenia Spectrum and Other Psychotic Disorders Mental Disorders Lisdexamfetamine Dimesylate Antipsychotic Agents Central Nervous System Stimulants Physiological Effects of Drugs Dopamine Uptake Inhibitors |
Neurotransmitter Uptake Inhibitors Membrane Transport Modulators Molecular Mechanisms of Pharmacological Action Dopamine Agents Neurotransmitter Agents Tranquilizing Agents Central Nervous System Depressants Psychotropic Drugs |
ClinicalTrials.gov processed this record on June 23, 2017