Clinical trial NCT01457339: Assess the Safety and Pharmacokinetics of Ascending, Multiple Oral Doses of SPD489 in Adults With Schizophrenia
Official title: A Phase 1, Randomized, Double-blind, Placebo Controlled Study to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Ascending, Multiple Oral Doses of SPD489 (Lisdexamfetamine Dimesylate) in Clinically Stable Adults With Schizophrenia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Schizophrenia
Keywords: Schizophrenia
Lead sponsor: Takeda
Sponsor class: INDUSTRY
First posted: 2011-10-21
Enrollment: 31
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: OTHER

Brief summary: This is a multiple ascending dose study; the purpose of this study is to examine the safety, tolerability and pharmacokinetics (levels of drug in the blood) of SPD489 in Schizophrenic Patients who are currently maintained on a stable dose of an antipsychotic medication.


Eligibility criteria: Subjects must be diagnosed with schizophrenia, on a stable dose of an antipsychotic and not have any cardiac risk factors

Primary outcomes:
measure: Change From Baseline in Systolic Blood Pressure at Day 5: 50 mg
timeFrame: Baseline and day 5
measure: Change From Baseline in Systolic Blood Pressure at Day 5: 70 mg
timeFrame: Baseline and day 5
measure: Change From Baseline in Systolic Blood Pressure at Day 5: 100 mg
timeFrame: Baseline and day 5
measure: Change From Baseline in Systolic Blood Pressure at Day 5: 150 mg
timeFrame: Baseline and day 5
measure: Change From Baseline in Systolic Blood Pressure at Day 5: 200 mg
timeFrame: Baseline and day 5
measure: Change From Baseline in Systolic Blood Pressure at Day 5: 250 mg
timeFrame: Baseline and day 5
measure: Change From Baseline in Diastolic Blood Pressure at Day 5: 50 mg
timeFrame: Baseline and day 5
measure: Change From Baseline in Diastolic Blood Pressure at Day 5: 70 mg
timeFrame: Baseline and day 5
measure: Change From Baseline in Diastolic Blood Pressure at Day 5: 100 mg
timeFrame: Baseline and day 5
measure: Change From Baseline in Diastolic Blood Pressure at Day 5: 150 mg
timeFrame: Baseline and day 5
measure: Change From Baseline in Diastolic Blood Pressure at Day 5: 200 mg
timeFrame: Baseline and day 5
measure: Change From Baseline in Diastolic Blood Pressure at Day 5: 250 mg
timeFrame: Baseline and day 5
measure: Change From Baseline in Pulse Rate at Day 5: 50 mg
timeFrame: Baseline and day 5
measure: Change From Baseline in Pulse Rate at Day 5: 70 mg
timeFrame: Baseline and day 5
measure: Change From Baseline in Pulse Rate at Day 5: 100 mg
timeFrame: Baseline and day 5
measure: Change From Baseline in Pulse Rate at Day 5: 150 mg
timeFrame: Baseline and day 5
measure: Change From Baseline in Pulse Rate at Day 5: 200 mg
timeFrame: Baseline and day 5
measure: Change From Baseline in Pulse Rate at Day 5: 250 mg
timeFrame: Baseline and day 5
Secondary outcomes:
measure: Area Under the Steady-state Plasma Concentration-time Curve (AUC) of Lisdexamfetamine Dimesylate on Day 5: 50 mg
timeFrame: Day 5 (12-hour sampling period post-dose)
measure: Area Under the Steady-state Plasma Concentration-time Curve (AUC) of Lisdexamfetamine Dimesylate on Day 5: 70 mg
timeFrame: Day 5 (12-hour sampling period post-dose)
measure: Area Under the Steady-state Plasma Concentration-time Curve (AUC) of Lisdexamfetamine Dimesylate on Day 5: 100 mg
timeFrame: Day 5 (12-hour sampling period post-dose)
measure: Area Under the Steady-state Plasma Concentration-time Curve (AUC) of Lisdexamfetamine Dimesylate on Day 5: 150 mg
timeFrame: Day 5 (12-hour sampling period post-dose)
measure: Area Under the Steady-state Plasma Concentration-time Curve (AUC) of Lisdexamfetamine Dimesylate on Day 5: 200 mg
timeFrame: Day 5 (12-hour sampling period post-dose)
measure: Area Under the Steady-state Plasma Concentration-time Curve (AUC) of Lisdexamfetamine Dimesylate on Day 5: 250 mg
timeFrame: Day 5 (12-hour sampling period post-dose)
measure: Maximum Plasma Concentration (Cmax) of Lisdexamfetamine Dimesylate on Day 5: 50 mg
timeFrame: Day 5 (12-hour sampling period post-dose)
measure: Maximum Plasma Concentration (Cmax) of Lisdexamfetamine Dimesylate on Day 5: 70 mg
timeFrame: Day 5 (12-hour sampling period post-dose)
measure: Maximum Plasma Concentration (Cmax) of Lisdexamfetamine Dimesylate on Day 5: 100 mg
timeFrame: Day 5 (12-hour sampling period post-dose)
measure: Maximum Plasma Concentration (Cmax) of Lisdexamfetamine Dimesylate on Day 5: 150 mg
timeFrame: Day 5 (12-hour sampling period post-dose)
measure: Maximum Plasma Concentration (Cmax) of Lisdexamfetamine Dimesylate on Day 5: 200 mg
timeFrame: Day 5 (12-hour sampling period post-dose)
measure: Maximum Plasma Concentration (Cmax) of Lisdexamfetamine Dimesylate on Day 5: 250 mg
timeFrame: Day 5 (12-hour sampling period post-dose)
measure: Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score at Day 5: 50 mg
timeFrame: Baseline and Day 5
measure: Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score at Day 5: 70 mg
timeFrame: Baseline and Day 5
measure: Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score at Day 5: 100 mg
timeFrame: Baseline and Day 5
measure: Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score at Day 5: 150 mg
timeFrame: Baseline and Day 5
measure: Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score at Day 5: 200 mg
timeFrame: Baseline and Day 5
measure: Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score at Day 5: 250 mg
timeFrame: Baseline and Day 5
measure: Change From Baseline in Scale for the Assessment of Negative Symptoms (SANS-18) Total Score at Day 5: 50 mg
timeFrame: Baseline and Day 5
measure: Change From Baseline in Scale for the Assessment of Negative Symptoms (SANS-18) Total Score at Day 5: 70 mg
timeFrame: Baseline and Day 5
measure: Change From Baseline in Scale for the Assessment of Negative Symptoms (SANS-18) Total Score at Day 5: 100 mg
timeFrame: Baseline and Day 5
measure: Change From Baseline in Scale for the Assessment of Negative Symptoms (SANS-18) Total Score at Day 5: 150 mg
timeFrame: Baseline and Day 5
measure: Change From Baseline in Scale for the Assessment of Negative Symptoms (SANS-18) Total Score at Day 5: 200 mg
timeFrame: Baseline and Day 5
measure: Change From Baseline in Scale for the Assessment of Negative Symptoms (SANS-18) Total Score at Day 5: 250 mg
timeFrame: Baseline and Day 5
measure: Change From Baseline in Calgary Depression Scale for Schizophrenia (CDSS) Total Score at Day 5: 50 mg
timeFrame: Baseline and Day 5
measure: Change From Baseline in Calgary Depression Scale for Schizophrenia (CDSS) Total Score at Day 5: 70 mg
timeFrame: Baseline and Day 5
measure: Change From Baseline in Calgary Depression Scale for Schizophrenia (CDSS) Total Score at Day 5: 100 mg
timeFrame: Baseline and Day 5
measure: Change From Baseline in Calgary Depression Scale for Schizophrenia (CDSS) Total Score at Day 5: 150 mg
timeFrame: Baseline and Day 5
measure: Change From Baseline in Calgary Depression Scale for Schizophrenia (CDSS) Total Score at Day 5: 200 mg
timeFrame: Baseline and Day 5
measure: Change From Baseline in Calgary Depression Scale for Schizophrenia (CDSS) Total Score at Day 5: 250 mg
timeFrame: Baseline and Day 5
measure: Change From Baseline in Simpson Angus Scale (SAS) Total Score at Day 5: 50 mg
timeFrame: Baseline and Day 5
measure: Change From Baseline in Simpson Angus Scale (SAS) Total Score at Day 5: 70 mg
timeFrame: Baseline and Day 5
measure: Change From Baseline in Simpson Angus Scale (SAS) Total Score at Day 5: 100 mg
timeFrame: Baseline and Day 5
measure: Change From Baseline in Simpson Angus Scale (SAS) Total Score at Day 5: 150 mg
timeFrame: Baseline and Day 5
measure: Change From Baseline in Simpson Angus Scale (SAS) Total Score at Day 5: 200 mg
timeFrame: Baseline and Day 5
measure: Change From Baseline in Simpson Angus Scale (SAS) Total Score at Day 5: 250 mg
timeFrame: Baseline and Day 5
measure: Change From Baseline in Barnes Akathisia Scale (BAS) Total Score at Day 5: 50 mg
timeFrame: Baseline and Day 5
measure: Change From Baseline in Barnes Akathisia Scale (BAS) Total Score at Day 5: 70 mg
timeFrame: Baseline and Day 5
measure: Change From Baseline in Barnes Akathisia Scale (BAS) Total Score at Day 5: 100 mg
timeFrame: Baseline and Day 5
measure: Change From Baseline in Barnes Akathisia Scale (BAS) Total Score at Day 5: 150 mg
timeFrame: Baseline and Day 5
measure: Change From Baseline in Barnes Akathisia Scale (BAS) Total Score at Day 5: 200 mg
timeFrame: Baseline and Day 5
measure: Change From Baseline in Barnes Akathisia Scale (BAS) Total Score at Day 5: 250 mg
timeFrame: Baseline and Day 5
measure: Change From Baseline in Cognitive Test Battery (CogState Battery) Score at Day 5: Groton Maze Learning Test, 50 mg
timeFrame: Baseline and Day 5
measure: Change From Baseline in Cognitive Test Battery (CogState Battery) Score at Day 5: Groton Maze Learning Test, 70 mg
timeFrame: Baseline and Day 5
measure: Change From Baseline in Cognitive Test Battery (CogState Battery) Score at Day 5: Groton Maze Learning Test, 100 mg
timeFrame: Baseline and Day 5
measure: Change From Baseline in Cognitive Test Battery (CogState Battery) Score at Day 5: Groton Maze Learning Test, 150 mg
timeFrame: Baseline and Day 5
measure: Change From Baseline in Cognitive Test Battery (CogState Battery) Score at Day 5: Groton Maze Learning Test, 200 mg
timeFrame: Baseline and Day 5
measure: Change From Baseline in Cognitive Test Battery (CogState Battery) Score at Day 5: Groton Maze Learning Test, 250 mg
timeFrame: Baseline and Day 5
measure: Change From Baseline in Cognitive Test Battery (CogState Battery) Score at Day 5: Detection Task, 50 mg
timeFrame: Baseline and Day 5
measure: Change From Baseline in Cognitive Test Battery (CogState Battery) Score at Day 5: Detection Task, 70 mg
timeFrame: Baseline and Day 5
measure: Change From Baseline in Cognitive Test Battery (CogState Battery) Score at Day 5: Detection Task, 100 mg
timeFrame: Baseline and Day 5
measure: Change From Baseline in Cognitive Test Battery (CogState Battery) Score at Day 5: Detection Task, 150 mg
timeFrame: Baseline and Day 5
measure: Change From Baseline in Cognitive Test Battery (CogState Battery) Score at Day 5: Detection Task, 200 mg
timeFrame: Baseline and Day 5
measure: Change From Baseline in Cognitive Test Battery (CogState Battery) Score at Day 5: Detection Task, 250 mg
timeFrame: Baseline and Day 5
measure: Change From Baseline in Cognitive Test Battery (CogState Battery) Score at Day 5: Identification Task, 50 mg
timeFrame: Baseline and Day 5
measure: Change From Baseline in Cognitive Test Battery (CogState Battery) Score at Day 5: Identification Task, 70 mg
timeFrame: Baseline and Day 5
measure: Change From Baseline in Cognitive Test Battery (CogState Battery) Score at Day 5: Identification Task, 100 mg
timeFrame: Baseline and Day 5
measure: Change From Baseline in Cognitive Test Battery (CogState Battery) Score at Day 5: Identification Task, 150 mg
timeFrame: Baseline and Day 5
measure: Change From Baseline in Cognitive Test Battery (CogState Battery) Score at Day 5: Identification Task, 200 mg
timeFrame: Baseline and Day 5
measure: Change From Baseline in Cognitive Test Battery (CogState Battery) Score at Day 5: Identification Task, 250 mg
timeFrame: Baseline and Day 5
measure: Change From Baseline in Cognitive Test Battery (CogState Battery) Score at Day 5: One Card Learning Task, 50 mg
timeFrame: Baseline and Day 5
measure: Change From Baseline in Cognitive Test Battery (CogState Battery) Score at Day 5: One Card Learning Task, 70 mg
timeFrame: Baseline and Day 5
measure: Change From Baseline in Cognitive Test Battery (CogState Battery) Score at Day 5: One Card Learning Task, 100 mg
timeFrame: Baseline and Day 5
measure: Change From Baseline in Cognitive Test Battery (CogState Battery) Score at Day 5: One Card Learning Task, 150 mg
timeFrame: Baseline and Day 5
measure: Change From Baseline in Cognitive Test Battery (CogState Battery) Score at Day 5: One Card Learning Task, 200 mg
timeFrame: Baseline and Day 5
measure: Change From Baseline in Cognitive Test Battery (CogState Battery) Score at Day 5: One Card Learning Task, 250 mg
timeFrame: Baseline and Day 5
Other outcomes:
Locations:
city: Glendale
country: United States
facility: California Clinical Trials
state: California
city: Long Beach
country: United States
facility: Collaborative Neuroscience Network, Inc
state: California
Study officials:
affiliation: Takeda
name: Study Director
role: STUDY_DIRECTOR
References: