SPD489 Low Dose and High Dose Ranges When Added to Stable Doses of Antipsychotic Medications in Clinically Stable Adults With Negative Symptoms of Schizophrenia

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

Status

Terminated

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01760889

Enrollment

Registered

2013-01-04

Start date

2013-02-01

Completion date

2013-04-01

Last updated

2021-06-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Schizophrenia

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.

Interventions

DRUGSPD489 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

DRUGSPD489 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

DRUGPlacebo

One capsule a day for 26 weeks

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Change From Baseline in Negative Symptom Assessment (NSA-16) Total Score at 26 Weeks	Baseline and 26 weeks

Secondary

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

Countries

United States

Participant flow

Pre-assignment details

Study was discontinued due to non-safety related business prioritization decisions. No subjects were randomized

Participants by arm

Arm	Count
SPD489 Low Dose Range 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	0
SPD489 High Dose Range 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	0
Placebo Placebo: One capsule a day for 26 weeks	0
Total	0

Baseline characteristics

Characteristic	—
Region of Enrollment United States	—

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk	EG002 affected / at risk
deaths Total, all-cause mortality	— / —	— / —	— / —
other Total, other adverse events	0 / 0	0 / 0	0 / 0
serious Total, serious adverse events	0 / 0	0 / 0	0 / 0