SPD489 Low Dose and High Dose Ranges 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 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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01760889
• Other study ID #: SPD489-335
• Secondary ID: 2012-003919-57
• 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 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 1
• 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 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
• 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
• Placebo
One capsule a day for 26 weeks

Locations

Country	Name	City	State
United States	Galiz Research	Miami Springs	Florida
United States	Psychiatric Care and Research Center	O'Fallon	Missouri
United States	CRI Lifetree	Philadelphia	Pennsylvania
United States	St. Charles Psychiatric Associates	Saint Charles	Missouri

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 Negative Symptom Assessment (NSA-16) Total Score at 26 Weeks		Baseline and 26 weeks
Secondary	Change From Baseline in the Personal and Social Performance (PSP) Scale Score at 26 Weeks		Baseline and 26 weeks
Secondary	Change From Baseline in Simpson Angus Scale (SAS) Total Score at 26 Weeks		Baseline and 26 weeks
Secondary	Change From Baseline in Barnes Akathisia Scale (BAS) Total Score at 26 Weeks		Baseline and 26 weeks
Secondary	Change From Baseline in the Abnormal Involuntary Movement Scale (AIMS) at 26 Weeks		Baseline and 26 weeks
Secondary	Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Scores at 26 Weeks		Baseline and 26 weeks
Secondary	Change From Baseline in Cognitive Test Battery (CogState Battery) Score at 26 Weeks		Baseline and 26 weeks
Secondary	Change From Baseline in Social Functioning Scale (SFS) at 26 Weeks		Baseline and 26 weeks
Secondary	Clinical Global Impression-Schizophrenia Severity of Illness (CGI-SCH-S) Scale		Baseline and week 26
Secondary	Clinical Global Impression-Schizophrenia Degree of Change (CGI-SCH-C) Scale		Up to 26 weeks
Secondary	Change From Baseline in Amphetamine Cessation Symptom Assessment (ACSA) Total Score at 26 Weeks		Baseline and 26 weeks
Secondary	Change From Baseline in Clinical Evaluation of Harmful Behavior (CEHB) Scale at 26 Weeks		Baseline and 26 weeks
Secondary	Columbia-Suicide Severity Rating Scale (C-SSRS)		Up to 26 weeks
Secondary	Change From Baseline in Calgary Depression Scale for Schizophrenia (CDSS) at 26 Weeks		Baseline and 26 weeks