Long-term Safety of SPD489 When Added to Stable Doses of Antipsychotic Medications in Clinically Stable Adults With Negative Symptoms of Schizophrenia

Schizophrenia Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01760993
• Other study ID #: SPD489-336
• Secondary ID: 2012-003920-18
• Status: Terminated
• Phase: Phase 3
• Start date: February 1, 2013
• Est. completion date: April 1, 2013

Study information

• Verified date: May 2021
• Source: Takeda
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

Not required

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 2
• Est. completion date: April 1, 2013
• Est. primary completion date: April 1, 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Schizophrenia

Intervention

Drug:
• SPD489
Once-daily oral optimized doses of SPD489 (either 40 mg, 80 mg, 100 mg, 120 mg, 140 mg, or 160 mg) for 52 weeks

Locations

Country	Name	City	State
United States	SP Research PLLC/Oklahoma Clinical Research Center	Oklahoma City	Oklahoma
United States	CRI Lifetree	Philadelphia	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Shire

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Scores at 52 Weeks		Basline and 52 weeks
Primary	Change From Baseline in Cognitive Test Battery (CogState Battery) Score at 52 Weeks		Baseline and 52 weeks
Primary	Columbia-Suicide Severity Rating Scale (C-SSRS)		Up to 52 weeks
Primary	Change From Baseline in Calgary Depression Scale for Schizophrenia (CDSS) at 52 Weeks		Baseline and 52 weeks
Primary	Change From Baseline in Simpson Angus Scale (SAS) Total Score at 52 Weeks		Baseline and 52 weeks
Primary	Change From Baseline in Barnes Akathisia Scale (BAS) Total Score at 52 Weeks		Baseline and 52 weeks
Primary	Change From Baseline in the Abnormal Involuntary Movement Scale (AIMS) at 52 Weeks		Baseline and 52 weeks
Primary	Change From Baseline in Clinical Evaluation of Harmful Behavior (CEHB) Scale at 52 Weeks		Baseline and 52 weeks
Primary	Change From Baseline in Amphetamine Cessation Symptom Assessment (ACSA) Total Score at 52 Weeks		Baseline and 52 weeks
Secondary	Change From Baseline in Negative Symptom Assessment (NSA-16) Total Score at 52 Weeks		Baseline and 52 weeks
Secondary	Change From Baseline in the Personal and Social Performance (PSP) Scale Score at 52 Weeks		Baseline and 52 weeks
Secondary	Clinical Global Impression-Schizophrenia Severity of Illness (CGI-SCH-S) Scale		Baseline and week 52
Secondary	Clinical Global Impression-Schizophrenia Degree of Change (CGI-SCH-C) Scale		Up to 52 weeks
Secondary	Change From Baseline in Social Functioning Scale (SFS) at 52 Weeks		Baseline and 52 weeks