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SPD489 Low Dose and High Dose Ranges 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:
Information provided by (Responsible Party):
Shire
ClinicalTrials.gov Identifier:
NCT01760889
First received: January 2, 2013
Last updated: May 1, 2014
Last verified: May 2014

January 2, 2013
May 1, 2014
February 2013
April 2013   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT01760889 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
SPD489 Low Dose and High Dose Ranges When Added to Stable Doses of Antipsychotic Medications in Clinically Stable Adults With Negative Symptoms of Schizophrenia
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

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.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Schizophrenia
  • 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
  • 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
  • Drug: Placebo
    One capsule a day for 26 weeks
  • Experimental: SPD489 Low Dose Range
    Intervention: Drug: SPD489 low dose range (40mg, 80mg, and 100mg)
  • Experimental: SPD489 High Dose Range
    Intervention: Drug: SPD489 high dose range (120mg, 140mg and 160mg)
  • Placebo Comparator: Placebo
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
1
April 2013
April 2013   (final data collection date for primary outcome measure)

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
Both
18 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01760889
SPD489-335, 2012-003919-57
Yes
Shire
Shire
Not Provided
Principal Investigator: Stephen R. Marder, MD Desert Pacific Mental Illness Research Education and Clinical Center Semel Institute for Neuroscience at UCLA
Shire
May 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP