Clinical trial NCT01760993: Long-term Safety of SPD489 When Added to Stable Doses of Antipsychotic Medications in Clinically Stable Adults With Negative Symptoms of Schizophrenia
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 type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Schizophrenia
Keywords: Not Required
Lead sponsor: Takeda
Sponsor class: INDUSTRY
First posted: 2013-01-04
Enrollment: 2
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Detailed description: Not required

Eligibility 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

Primary outcomes:
measure: Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Scores at 52 Weeks
timeFrame: Basline and 52 weeks
measure: Change From Baseline in Cognitive Test Battery (CogState Battery) Score at 52 Weeks
timeFrame: Baseline and 52 weeks
measure: Columbia-Suicide Severity Rating Scale (C-SSRS)
timeFrame: Up to 52 weeks
measure: Change From Baseline in Calgary Depression Scale for Schizophrenia (CDSS) at 52 Weeks
timeFrame: Baseline and 52 weeks
measure: Change From Baseline in Simpson Angus Scale (SAS) Total Score at 52 Weeks
timeFrame: Baseline and 52 weeks
measure: Change From Baseline in Barnes Akathisia Scale (BAS) Total Score at 52 Weeks
timeFrame: Baseline and 52 weeks
measure: Change From Baseline in the Abnormal Involuntary Movement Scale (AIMS) at 52 Weeks
timeFrame: Baseline and 52 weeks
measure: Change From Baseline in Clinical Evaluation of Harmful Behavior (CEHB) Scale at 52 Weeks
timeFrame: Baseline and 52 weeks
measure: Change From Baseline in Amphetamine Cessation Symptom Assessment (ACSA) Total Score at 52 Weeks
timeFrame: Baseline and 52 weeks
Secondary outcomes:
measure: Change From Baseline in Negative Symptom Assessment (NSA-16) Total Score at 52 Weeks
timeFrame: Baseline and 52 weeks
measure: Change From Baseline in the Personal and Social Performance (PSP) Scale Score at 52 Weeks
timeFrame: Baseline and 52 weeks
measure: Clinical Global Impression-Schizophrenia Severity of Illness (CGI-SCH-S) Scale
timeFrame: Baseline and week 52
measure: Clinical Global Impression-Schizophrenia Degree of Change (CGI-SCH-C) Scale
timeFrame: Up to 52 weeks
measure: Change From Baseline in Social Functioning Scale (SFS) at 52 Weeks
timeFrame: Baseline and 52 weeks
Other outcomes:
Locations:
city: Oklahoma City
country: United States
facility: SP Research PLLC/Oklahoma Clinical Research Center
state: Oklahoma
city: Philadelphia
country: United States
facility: CRI Lifetree
state: Pennsylvania
Study officials:
affiliation: Takeda
name: Study Director
role: STUDY_DIRECTOR
References: