Phase 1
Completed N=31
Assess the Safety and Pharmacokinetics of Ascending, Multiple Oral Doses of SPD489 in Adults With Schizophrenia
Source: ClinicalTrials.gov NCT01457339 ↗Enrolled (actual)
31
Serious AEs
0.0%
Results posted
Jan 2013
Primary outcomePrimary: Change From Baseline in Systolic Blood Pressure at Day 5: 50 mg — -0.14; 8.94 mmHg
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Systolic Blood Pressure at Day 5: 50 mg |
-0.14; 8.94 | — |
| PRIMARY Change From Baseline in Systolic Blood Pressure at Day 5: 70 mg |
1.43; 3.82 | — |
| PRIMARY Change From Baseline in Systolic Blood Pressure at Day 5: 100 mg |
0.43; 4.96 | — |
| PRIMARY Change From Baseline in Systolic Blood Pressure at Day 5: 150 mg |
-2.81; 6.43 | — |
| PRIMARY Change From Baseline in Systolic Blood Pressure at Day 5: 200 mg |
-2.38; 5.28 | — |
| PRIMARY Change From Baseline in Systolic Blood Pressure at Day 5: 250 mg |
-0.28; 7.36 | — |
| PRIMARY Change From Baseline in Diastolic Blood Pressure at Day 5: 50 mg |
2.86; 5.22 | — |
| PRIMARY Change From Baseline in Diastolic Blood Pressure at Day 5: 70 mg |
2.38; 2.14 | — |
| PRIMARY Change From Baseline in Diastolic Blood Pressure at Day 5: 100 mg |
2.14; 4.55 | — |
| PRIMARY Change From Baseline in Diastolic Blood Pressure at Day 5: 150 mg |
2.67; 2.43 | — |
| PRIMARY Change From Baseline in Diastolic Blood Pressure at Day 5: 200 mg |
2.76; 3.77 | — |
| PRIMARY Change From Baseline in Diastolic Blood Pressure at Day 5: 250 mg |
3.67; 3.79 | — |
| PRIMARY Change From Baseline in Pulse Rate at Day 5: 50 mg |
2.62; 3.78 | — |
| PRIMARY Change From Baseline in Pulse Rate at Day 5: 70 mg |
-0.95; 5.07 | — |
| PRIMARY Change From Baseline in Pulse Rate at Day 5: 100 mg |
0.19; 5.72 | — |
| PRIMARY Change From Baseline in Pulse Rate at Day 5: 150 mg |
-1.05; 6.41 | — |
| PRIMARY Change From Baseline in Pulse Rate at Day 5: 200 mg |
2.38; 8.88 | — |
| PRIMARY Change From Baseline in Pulse Rate at Day 5: 250 mg |
2.06; 12.39 | — |
| SECONDARY Area Under the Steady-state Plasma Concentration-time Curve (AUC) of Lisdexamfetamine Dimesylate on Day 5: 50 mg |
25.6 | — |
| SECONDARY Area Under the Steady-state Plasma Concentration-time Curve (AUC) of Lisdexamfetamine Dimesylate on Day 5: 70 mg |
43.7 | — |
| SECONDARY Area Under the Steady-state Plasma Concentration-time Curve (AUC) of Lisdexamfetamine Dimesylate on Day 5: 100 mg |
80.5 | — |
| SECONDARY Area Under the Steady-state Plasma Concentration-time Curve (AUC) of Lisdexamfetamine Dimesylate on Day 5: 150 mg |
144.9 | — |
| SECONDARY Area Under the Steady-state Plasma Concentration-time Curve (AUC) of Lisdexamfetamine Dimesylate on Day 5: 200 mg |
230.2 | — |
| SECONDARY Area Under the Steady-state Plasma Concentration-time Curve (AUC) of Lisdexamfetamine Dimesylate on Day 5: 250 mg |
301.5 | — |
| SECONDARY Maximum Plasma Concentration (Cmax) of Lisdexamfetamine Dimesylate on Day 5: 50 mg |
21.93 | — |
| SECONDARY Maximum Plasma Concentration (Cmax) of Lisdexamfetamine Dimesylate on Day 5: 70 mg |
35.02 | — |
| SECONDARY Maximum Plasma Concentration (Cmax) of Lisdexamfetamine Dimesylate on Day 5: 100 mg |
50.6 | — |
| SECONDARY Maximum Plasma Concentration (Cmax) of Lisdexamfetamine Dimesylate on Day 5: 150 mg |
90.34 | — |
| SECONDARY Maximum Plasma Concentration (Cmax) of Lisdexamfetamine Dimesylate on Day 5: 200 mg |
133.3 | — |
| SECONDARY Maximum Plasma Concentration (Cmax) of Lisdexamfetamine Dimesylate on Day 5: 250 mg |
181.53 | — |
| SECONDARY Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score at Day 5: 50 mg |
0.6; -1.9 | — |
| SECONDARY Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score at Day 5: 70 mg |
-2.1; -2.9 | — |
| SECONDARY Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score at Day 5: 100 mg |
-3.6; -3.9 | — |
| SECONDARY Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score at Day 5: 150 mg |
-2.1; -4.7 | — |
| SECONDARY Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score at Day 5: 200 mg |
-2.3; -4.6 | — |
| SECONDARY Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score at Day 5: 250 mg |
-2.3; -2.4 | — |
| SECONDARY Change From Baseline in Scale for the Assessment of Negative Symptoms (SANS-18) Total Score at Day 5: 50 mg |
-1.4; -1.7 | — |
| SECONDARY Change From Baseline in Scale for the Assessment of Negative Symptoms (SANS-18) Total Score at Day 5: 70 mg |
-3.0; -3.1 | — |
| SECONDARY Change From Baseline in Scale for the Assessment of Negative Symptoms (SANS-18) Total Score at Day 5: 100 mg |
-7.0; -2.6 | — |
| SECONDARY Change From Baseline in Scale for the Assessment of Negative Symptoms (SANS-18) Total Score at Day 5: 150 mg |
-4.0; -3.0 | — |
| SECONDARY Change From Baseline in Scale for the Assessment of Negative Symptoms (SANS-18) Total Score at Day 5: 200 mg |
1.3; -2.6 | — |
| SECONDARY Change From Baseline in Scale for the Assessment of Negative Symptoms (SANS-18) Total Score at Day 5: 250 mg |
-4.2; -3.3 | — |
| SECONDARY Change From Baseline in Calgary Depression Scale for Schizophrenia (CDSS) Total Score at Day 5: 50 mg |
0.0; -0.3 | — |
| SECONDARY Change From Baseline in Calgary Depression Scale for Schizophrenia (CDSS) Total Score at Day 5: 70 mg |
-0.4; -0.7 | — |
| SECONDARY Change From Baseline in Calgary Depression Scale for Schizophrenia (CDSS) Total Score at Day 5: 100 mg |
-0.4; -0.9 | — |
| SECONDARY Change From Baseline in Calgary Depression Scale for Schizophrenia (CDSS) Total Score at Day 5: 150 mg |
-0.7; -1.0 | — |
| SECONDARY Change From Baseline in Calgary Depression Scale for Schizophrenia (CDSS) Total Score at Day 5: 200 mg |
-0.4; -0.6 | — |
| SECONDARY Change From Baseline in Calgary Depression Scale for Schizophrenia (CDSS) Total Score at Day 5: 250 mg |
-0.2; -0.3 | — |
| SECONDARY Change From Baseline in Simpson Angus Scale (SAS) Total Score at Day 5: 50 mg |
-0.4; 0.0 | — |
| SECONDARY Change From Baseline in Simpson Angus Scale (SAS) Total Score at Day 5: 70 mg |
-0.6; -0.1 | — |
| SECONDARY Change From Baseline in Simpson Angus Scale (SAS) Total Score at Day 5: 100 mg |
-0.4; 0.0 | — |
| SECONDARY Change From Baseline in Simpson Angus Scale (SAS) Total Score at Day 5: 150 mg |
-0.3; 0.1 | — |
| SECONDARY Change From Baseline in Simpson Angus Scale (SAS) Total Score at Day 5: 200 mg |
0.0; 0.0 | — |
| SECONDARY Change From Baseline in Simpson Angus Scale (SAS) Total Score at Day 5: 250 mg |
0.2; 0.0 | — |
| SECONDARY Change From Baseline in Barnes Akathisia Scale (BAS) Total Score at Day 5: 50 mg |
0.0; 0.0 | — |
| SECONDARY Change From Baseline in Barnes Akathisia Scale (BAS) Total Score at Day 5: 70 mg |
0.0; 0.0 | — |
| SECONDARY Change From Baseline in Barnes Akathisia Scale (BAS) Total Score at Day 5: 100 mg |
0.0; 0.0 | — |
| SECONDARY Change From Baseline in Barnes Akathisia Scale (BAS) Total Score at Day 5: 150 mg |
0.0; 0.0 | — |
| SECONDARY Change From Baseline in Barnes Akathisia Scale (BAS) Total Score at Day 5: 200 mg |
0.0; 0.2 | — |
| SECONDARY Change From Baseline in Barnes Akathisia Scale (BAS) Total Score at Day 5: 250 mg |
0.0; 0.0 | — |
| SECONDARY Change From Baseline in Cognitive Test Battery (CogState Battery) Score at Day 5: Groton Maze Learning Test, 50 mg |
-0.9; -8.2 | — |
| SECONDARY Change From Baseline in Cognitive Test Battery (CogState Battery) Score at Day 5: Groton Maze Learning Test, 70 mg |
8.7; -7.3 | — |
| SECONDARY Change From Baseline in Cognitive Test Battery (CogState Battery) Score at Day 5: Groton Maze Learning Test, 100 mg |
0.9; -15.7 | — |
| SECONDARY Change From Baseline in Cognitive Test Battery (CogState Battery) Score at Day 5: Groton Maze Learning Test, 150 mg |
21.1; -11.3 | — |
| SECONDARY Change From Baseline in Cognitive Test Battery (CogState Battery) Score at Day 5: Groton Maze Learning Test, 200 mg |
-10.3; -16.5 | — |
| SECONDARY Change From Baseline in Cognitive Test Battery (CogState Battery) Score at Day 5: Groton Maze Learning Test, 250 mg |
-5.0; -13.2 | — |
| SECONDARY Change From Baseline in Cognitive Test Battery (CogState Battery) Score at Day 5: Detection Task, 50 mg |
0.0; -0.034 | — |
| SECONDARY Change From Baseline in Cognitive Test Battery (CogState Battery) Score at Day 5: Detection Task, 70 mg |
0.017; -0.015 | — |
| SECONDARY Change From Baseline in Cognitive Test Battery (CogState Battery) Score at Day 5: Detection Task, 100 mg |
0.014; -0.047 | — |
| SECONDARY Change From Baseline in Cognitive Test Battery (CogState Battery) Score at Day 5: Detection Task, 150 mg |
0.037; -0.039 | — |
| SECONDARY Change From Baseline in Cognitive Test Battery (CogState Battery) Score at Day 5: Detection Task, 200 mg |
-0.025; -0.049 | — |
| SECONDARY Change From Baseline in Cognitive Test Battery (CogState Battery) Score at Day 5: Detection Task, 250 mg |
-0.034; -0.048 | — |
| SECONDARY Change From Baseline in Cognitive Test Battery (CogState Battery) Score at Day 5: Identification Task, 50 mg |
0.028; 0.001 | — |
| SECONDARY Change From Baseline in Cognitive Test Battery (CogState Battery) Score at Day 5: Identification Task, 70 mg |
0.015; 0.006 | — |
| SECONDARY Change From Baseline in Cognitive Test Battery (CogState Battery) Score at Day 5: Identification Task, 100 mg |
0.011; 0.001 | — |
| SECONDARY Change From Baseline in Cognitive Test Battery (CogState Battery) Score at Day 5: Identification Task, 150 mg |
0.036; -0.010 | — |
| SECONDARY Change From Baseline in Cognitive Test Battery (CogState Battery) Score at Day 5: Identification Task, 200 mg |
0.044; -0.014 | — |
| SECONDARY Change From Baseline in Cognitive Test Battery (CogState Battery) Score at Day 5: Identification Task, 250 mg |
0.005; -0.007 | — |
| SECONDARY Change From Baseline in Cognitive Test Battery (CogState Battery) Score at Day 5: One Card Learning Task, 50 mg |
0.025; 0.005 | — |
| SECONDARY Change From Baseline in Cognitive Test Battery (CogState Battery) Score at Day 5: One Card Learning Task, 70 mg |
0.015; 0.021 | — |
| SECONDARY Change From Baseline in Cognitive Test Battery (CogState Battery) Score at Day 5: One Card Learning Task, 100 mg |
0.012; 0.012 | — |
| SECONDARY Change From Baseline in Cognitive Test Battery (CogState Battery) Score at Day 5: One Card Learning Task, 150 mg |
0.026; 0.042 | — |
| SECONDARY Change From Baseline in Cognitive Test Battery (CogState Battery) Score at Day 5: One Card Learning Task, 200 mg |
-0.020; 0.046 | — |
| SECONDARY Change From Baseline in Cognitive Test Battery (CogState Battery) Score at Day 5: One Card Learning Task, 250 mg |
0.018; 0.022 | — |
Eligibility Criteria
Subjects must be diagnosed with schizophrenia, on a stable dose of an antipsychotic and not have any cardiac risk factors
Data sourced from ClinicalTrials.gov (NCT01457339). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.