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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ClinicalTrials.gov Identifier: NCT01760889 |
Recruitment Status :
Terminated
(Study was discontinued due to non-safety related business prioritization decisions. No subjects were randomized)
First Posted : January 4, 2013
Results First Posted : May 29, 2014
Last Update Posted : May 29, 2014
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Condition or disease | Intervention/treatment | 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 (Clinical Trial) |
Actual Enrollment : | 1 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Quadruple (Participant, Care Provider, 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 |
Study Start Date : | February 2013 |
Actual Primary Completion Date : | April 2013 |
Actual Study Completion Date : | April 2013 |

Arm | Intervention/treatment |
---|---|
Experimental: SPD489 Low Dose Range |
Drug: SPD489 low dose range (40mg, 80mg, and 100mg)
Capsule, dose titration,
Other Name: lisdexamfetamine dimesylate, LDX, Vyvanse |
Experimental: SPD489 High Dose Range |
Drug: SPD489 high dose range (120mg, 140mg and 160mg)
Capsule, dose titration,
Other Name: lisdexamfetamine dimesylate, LDX, Vyvanse |
Placebo Comparator: Placebo |
Drug: Placebo
One capsule a day for 26 weeks |
- Change From Baseline in Negative Symptom Assessment (NSA-16) Total Score at 26 Weeks [ Time Frame: Baseline and 26 weeks ]
- Change From Baseline in the Personal and Social Performance (PSP) Scale Score at 26 Weeks [ Time Frame: Baseline and 26 weeks ]
- Change From Baseline in Simpson Angus Scale (SAS) Total Score at 26 Weeks [ Time Frame: Baseline and 26 weeks ]
- Change From Baseline in Barnes Akathisia Scale (BAS) Total Score at 26 Weeks [ Time Frame: Baseline and 26 weeks ]
- Change From Baseline in the Abnormal Involuntary Movement Scale (AIMS) at 26 Weeks [ Time Frame: Baseline and 26 weeks ]
- Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Scores at 26 Weeks [ Time Frame: Baseline and 26 weeks ]
- Change From Baseline in Cognitive Test Battery (CogState Battery) Score at 26 Weeks [ Time Frame: Baseline and 26 weeks ]
- Change From Baseline in Social Functioning Scale (SFS) at 26 Weeks [ Time Frame: Baseline and 26 weeks ]
- Clinical Global Impression-Schizophrenia Severity of Illness (CGI-SCH-S) Scale [ Time Frame: Baseline and week 26 ]
- Clinical Global Impression-Schizophrenia Degree of Change (CGI-SCH-C) Scale [ Time Frame: Up to 26 weeks ]
- Change From Baseline in Amphetamine Cessation Symptom Assessment (ACSA) Total Score at 26 Weeks [ Time Frame: Baseline and 26 weeks ]
- Change From Baseline in Clinical Evaluation of Harmful Behavior (CEHB) Scale at 26 Weeks [ Time Frame: Baseline and 26 weeks ]
- Columbia-Suicide Severity Rating Scale (C-SSRS) [ Time Frame: Up to 26 weeks ]
- Change From Baseline in Calgary Depression Scale for Schizophrenia (CDSS) at 26 Weeks [ Time Frame: Baseline and 26 weeks ]

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Ages Eligible for Study: | 18 Years to 65 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01760889
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 |
Principal Investigator: | Stephen R. Marder, MD | Desert Pacific Mental Illness Research Education and Clinical Center Semel Institute for Neuroscience at UCLA |
Responsible Party: | Shire |
ClinicalTrials.gov Identifier: | NCT01760889 |
Other Study ID Numbers: |
SPD489-335 2012-003919-57 ( EudraCT Number ) |
First Posted: | January 4, 2013 Key Record Dates |
Results First Posted: | May 29, 2014 |
Last Update Posted: | May 29, 2014 |
Last Verified: | May 2014 |
Schizophrenia Schizophrenia Spectrum and Other Psychotic Disorders Mental Disorders Lisdexamfetamine Dimesylate 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 |