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

• ClinicalTrials.gov Identifier: NCT01760889
• 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 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 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 Design

• 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

Arms and Interventions

Arm	Intervention/treatment
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

Outcome Measures

Primary Outcome Measures :

1. Change From Baseline in Negative Symptom Assessment (NSA-16) Total Score at 26 Weeks [ Time Frame: Baseline and 26 weeks ]

Secondary Outcome Measures :

1. Change From Baseline in the Personal and Social Performance (PSP) Scale Score at 26 Weeks [ Time Frame: Baseline and 26 weeks ]
2. Change From Baseline in Simpson Angus Scale (SAS) Total Score at 26 Weeks [ Time Frame: Baseline and 26 weeks ]
3. Change From Baseline in Barnes Akathisia Scale (BAS) Total Score at 26 Weeks [ Time Frame: Baseline and 26 weeks ]
4. Change From Baseline in the Abnormal Involuntary Movement Scale (AIMS) at 26 Weeks [ Time Frame: Baseline and 26 weeks ]
5. Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Scores at 26 Weeks [ Time Frame: Baseline and 26 weeks ]
6. Change From Baseline in Cognitive Test Battery (CogState Battery) Score at 26 Weeks [ Time Frame: Baseline and 26 weeks ]
7. Change From Baseline in Social Functioning Scale (SFS) at 26 Weeks [ Time Frame: Baseline and 26 weeks ]
8. Clinical Global Impression-Schizophrenia Severity of Illness (CGI-SCH-S) Scale [ Time Frame: Baseline and week 26 ]
9. Clinical Global Impression-Schizophrenia Degree of Change (CGI-SCH-C) Scale [ Time Frame: Up to 26 weeks ]
10. Change From Baseline in Amphetamine Cessation Symptom Assessment (ACSA) Total Score at 26 Weeks [ Time Frame: Baseline and 26 weeks ]
11. Change From Baseline in Clinical Evaluation of Harmful Behavior (CEHB) Scale at 26 Weeks [ Time Frame: Baseline and 26 weeks ]
12. Columbia-Suicide Severity Rating Scale (C-SSRS) [ Time Frame: Up to 26 weeks ]
13. Change From Baseline in Calgary Depression Scale for Schizophrenia (CDSS) at 26 Weeks [ Time Frame: Baseline and 26 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, 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

• Responsible Party: Shire
• ClinicalTrials.gov Identifier: NCT01760889
• Other Study ID Numbers: SPD489-335; 2012-003919-57 ( EudraCT Number )
• First Posted: January 4, 2013
• Results First Posted: May 29, 2014
• Last Update Posted: May 29, 2014
• Last Verified: May 2014

Additional relevant MeSH terms:

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