Clinical trial NCT01760889: SPD489 Low Dose and High Dose Ranges When Added to Stable Doses of Antipsychotic Medications in Clinically Stable Adults With Negative Symptoms of Schizophrenia
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 type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Schizophrenia
Lead sponsor: Takeda
Sponsor class: INDUSTRY
First posted: 2013-01-04
Enrollment: 1
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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 Negative Symptom Assessment (NSA-16) Total Score at 26 Weeks
timeFrame: Baseline and 26 weeks
Secondary outcomes:
measure: Change From Baseline in the Personal and Social Performance (PSP) Scale Score at 26 Weeks
timeFrame: Baseline and 26 weeks
measure: Change From Baseline in Simpson Angus Scale (SAS) Total Score at 26 Weeks
timeFrame: Baseline and 26 weeks
measure: Change From Baseline in Barnes Akathisia Scale (BAS) Total Score at 26 Weeks
timeFrame: Baseline and 26 weeks
measure: Change From Baseline in the Abnormal Involuntary Movement Scale (AIMS) at 26 Weeks
timeFrame: Baseline and 26 weeks
measure: Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Scores at 26 Weeks
timeFrame: Baseline and 26 weeks
measure: Change From Baseline in Cognitive Test Battery (CogState Battery) Score at 26 Weeks
timeFrame: Baseline and 26 weeks
measure: Change From Baseline in Social Functioning Scale (SFS) at 26 Weeks
timeFrame: Baseline and 26 weeks
measure: Clinical Global Impression-Schizophrenia Severity of Illness (CGI-SCH-S) Scale
timeFrame: Baseline and week 26
measure: Clinical Global Impression-Schizophrenia Degree of Change (CGI-SCH-C) Scale
timeFrame: Up to 26 weeks
measure: Change From Baseline in Amphetamine Cessation Symptom Assessment (ACSA) Total Score at 26 Weeks
timeFrame: Baseline and 26 weeks
measure: Change From Baseline in Clinical Evaluation of Harmful Behavior (CEHB) Scale at 26 Weeks
timeFrame: Baseline and 26 weeks
measure: Columbia-Suicide Severity Rating Scale (C-SSRS)
timeFrame: Up to 26 weeks
measure: Change From Baseline in Calgary Depression Scale for Schizophrenia (CDSS) at 26 Weeks
timeFrame: Baseline and 26 weeks
Other outcomes:
Locations:
city: Miami Springs
country: United States
facility: Galiz Research
state: Florida
city: O'Fallon
country: United States
facility: Psychiatric Care and Research Center
state: Missouri
city: Saint Charles
country: United States
facility: St. Charles Psychiatric Associates
state: Missouri
city: Philadelphia
country: United States
facility: CRI Lifetree
state: Pennsylvania
Study officials:
affiliation: Takeda
name: Study Director
role: STUDY_DIRECTOR
References: