Adjunctive SPD489 to Antipsychotic Medication in Clinically Stable Adults With Persistent Predominant Negative Symptoms of Schizophrenia

Schizophrenia Clinical Trial

Official title:

A Phase 3 Multicenter, Randomized, Double-blind, Parallel-group, Placebo-controlled, 12-week, Forced-dose Titration Study to Evaluate the Efficacy, Safety, and Tolerability of SPD489 40mg, 100mg, or 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: NCT01738698
• Other study ID #: SPD489-338
• Secondary ID: 2012-003918-14
• Status: Terminated
• Phase: Phase 3
• Start date: November 1, 2012
• 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 40 mg, 100 mg, and 160 mg are effective and safe in the treatment of Negative Symptoms of Schizophrenia (NSS).

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 4
• 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 day

Related Conditions & MeSH terms

• Schizophrenia

Intervention

Drug:
• SPD489 40mg
Oral administration of 40 mg once-daily for up to 12 weeks
• SPD489 100mg
Oral administration of 100 mg once-daily for up to 12 weeks
• SPD489 160mg
Oral administration of 160 mg once-daily for up to 12 weeks
• Placebo
Oral administration once-daily for 12 weeks

Locations

Country	Name	City	State
United States	University Hills Clinical Research	Irving	Texas

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 - 16-item (NSA-16) Total Score at 12 Weeks		Baseline and 12 weeks
Secondary	Change From Baseline in the Personal and Social Performance Scale (PSP) Score at 12 Weeks		Baseline and 12 weeks
Secondary	Change From Baseline in Simpson Angus Scale (SAS) Total Score at 12 Weeks		Baseline and 12 weeks
Secondary	Change From Baseline in Barnes Akathisia Scale (BAS) Total Score at 12 Weeks		Baseline and 12 weeks
Secondary	Change From Baseline in Amphetamine Cessation Symptom Assessment (ACSA) Total Score at 12 Weeks		Baseline and 12 weeks
Secondary	Change From Baseline in the Abnormal Involuntary Movement Scale (AIMS) at 12 Weeks		Baseline and 12 weeks
Secondary	Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Scores at 12 Weeks		Baseline and 12 weeks
Secondary	Change From Baseline in Cognitive Test Battery (CogState Battery) Score at 12 Weeks		Baseline and 12 weeks
Secondary	Change From Baseline in Social Functioning Scale (SFS) at 12 Weeks		Baseline and 12 weeks
Secondary	Change From Baseline in Clinical Evaluation of Harmful Behavior (CEHB) Scale at 12 Weeks		Baseline and 12 weeks
Secondary	Clinical Global Impression-Schizophrenia Severity of Illness (CGI-SCH-S) Scale		Baseline and week 12
Secondary	Clinical Global Impression-Schizophrenia Degree of Change (CGI-SCH-C) Scale		Up to 12 weeks
Secondary	Columbia-Suicide Severity Rating Scale (C-SSRS)		Up to 12 weeks
Secondary	Change From Baseline in Calgary Depression Scale for Schizophrenia (CDSS) at 12 Weeks		Baseline and 12 weeks
Secondary	Ambulatory Blood Pressure Monitoring (ABPM)		Baseline and Weeks 4 and 10