Phase 2 N=92 Randomized Quadruple-blind Treatment

Efficacy, Safety, and Tolerability of SPD489 in Adults With Schizophrenia and Predominant Negative Symptoms

Schizophrenia and Predominant Negative Symptoms

Bottom Line

View on ClinicalTrials.gov: NCT00922272 ↗

Enrolled (actual)

Serious AEs

3.7%

Results posted

Feb 2012

Primary outcome: Primary: Change From Open-label Baseline in Modified Scale for the Assessment of Negative Symptoms (SANS-18) Total Score at Week 10 Open-label Phase, Last Observation Carried Forward (LOCF) — -12.9 Units on a scale — p=<0.0001

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: SPD489 (lisdexamfetamine dimesylate) (Drug); Placebo matching SPD489 (lisdexamfetamine dimesylate) (Drug)
Age: Adult · 18+ yrs
Sex: All
Sponsor: Shire
Primary completion: Jan 2011

Outcome Measures

Outcome	Result	p-value
PRIMARY Change From Open-label Baseline in Modified Scale for the Assessment of Negative Symptoms (SANS-18) Total Score at Week 10 Open-label Phase, Last Observation Carried Forward (LOCF)	-12.9	<0.0001 sig
PRIMARY Change From Double-blind Randomization Baseline in SANS-18 Total Score at Week 4 Double-blind Phase, Termination Observation Carried Forward (TOCF)	4.5; 2.2	0.4182
SECONDARY Percent of Participants In Open-label Phase Who Were SANS-18 Responders at Week 10 Open-label Phase	52.9	—
SECONDARY Percent of Participants In Double-blind Phase Who Maintained SANS-18 Response at Week 4 Double-blind Phase	71.4; 82.4	0.6705
SECONDARY Change From Open-label Baseline in SANS Global Scores at Week 10 Open-label Phase	-0.9; -0.9; -0.5; -0.7; -0.7	<0.0001 sig
SECONDARY Change From Double-blind Randomization Baseline in SANS Global Scores at Week 4 Double-blind Phase	0.2; 0.2; 0.5; 0.0; 0.2; 0.1	0.8771
SECONDARY Change From Open-label Baseline in Positive and Negative Syndrome Scale (PANSS) Scores at Week 10 Open-label Phase, LOCF	-1.0; -4.8; -4.0	<0.0001 sig
SECONDARY Change From Double-blind Randomization Baseline in PANSS Scores at Week 4 Double-blind Phase, TOCF	0.5; -0.1; 0.9; -0.1; 0.9; -0.9	0.1975
SECONDARY Percent of Participants With Clinical Global Impression - Severity of Illness (CGI-S) at Open-label Baseline	0; 0; 29.3; 55.4; 14.1; 1.1	—
SECONDARY Percent of Participants With CGI-S at Week 10 Open-label Phase	0; 2.9; 54.3; 38.6; 4.3; 0	—
SECONDARY Percent of Participants With CGI-S at Double-blind Randomization Baseline	0; 0; 2.9; 2.9; 50.0; 60.0	—
SECONDARY Percent of Participants With CGI-S at Week 4 Double-blind Phase	0; 0; 3.4; 13.8; 34.5; 69.0	—
SECONDARY Percent of Participants With Improvement on Clinical Global Impression - Change (CGI-C) at Week 10 Open-label Phase	30.0	—
SECONDARY Percent of Participants With Improvement on CGI-C at Week 4 Double-blind Phase	17.2; 27.6	—
SECONDARY Change From Open-label Baseline in the Brief Assessment of Cognition in Schizophrenia (BACS) Total Score at Week 10 Open-label Phase	2.3	0.0307 sig
SECONDARY Change From Double-blind Randomization Baseline in BACS Total Score at Week 4 Double-blind Phase	0.1; -2.7	0.1072
SECONDARY Change From Open-label Baseline in Letter-Number Span Test (LNS) Total Score at Week 10 Open-label Phase	0.8	0.3660
SECONDARY Change From Double-blind Randomization Baseline in LNS Total Score at Week 4 Double-blind Phase	-0.1; 1.3	0.4347
SECONDARY Change From Open-label Baseline in Hopkins Verbal Learning Test - Revised (HVLT-R) Total Score at Week 10 Open-label Phase	0.7	0.4312
SECONDARY Change From Double-blind Randomization Baseline in HVLT-R Total Scores at Week 4 Double-blind Phase	-1.5; 1.0	0.0874
SECONDARY Change From Open-label Baseline in University of California Performance-Based Skills Assessment, Brief Version (UPSA-B) Scores at Week 10 Open-label Phase, LOCF	6.2; 3.7; 2.5	<0.0001 sig
SECONDARY Change From Double-blind Randomization Baseline in UPSA-B Scores at Week 4 Double-blind Phase	-1.5; 0.0; -1.5; -0.6; -0.3; 0.9	0.4637
SECONDARY Change From Open-label Baseline in Behavioral Rating Inventory of Executive Function - Adult Version (BRIEF-A) T-scores at Week 10 Open-label Phase	-3.9; -3.1; -3.9	0.0174 sig
SECONDARY Change From Double-blind Randomization Baseline in BRIEF-A T-Scores at Week 4 Double-blind Phase	-1.7; -1.2; -0.9; -1.6; -2.0; -0.7	0.7418
SECONDARY Change From Open-label Baseline in Simpson Angus Scale (SAS) Total Score at Week 10 Open-label Phase	-0.01	—
SECONDARY Change From Open-label Baseline in SAS Total Score at Week 4 of Double-blind Phase	0.00; 0.00	—
SECONDARY Change From Open-label Baseline in Barnes Akathisia Scale (BAS) Scores at Week 10 Open-label Phase	0.0; 0.0; 0.0	—
SECONDARY Change From Open-label Baseline in BAS Scores at Week 4 of Double-blind Phase	0.0; -0.1; 0.0; -0.1; 0.0; -0.2	—
SECONDARY Change From Open-label Baseline in Amphetamine Cessation Symptom Assessment (ACSA) Total Score at Week 10 Open-label Phase	-1.8	—
SECONDARY Change From Double-blind Randomization Baseline in ACSA Total Score at Week 4 Double-blind Phase	0.4; -2.9	—
SECONDARY Change From Open-label Baseline in Pittsburgh Sleep Quality Index (PSQI) Total Global Score at Week 10 Open-label Phase	-0.7	—
SECONDARY Change From Open-label Baseline in PSQI Total Global Score at Week 4 of Double-blind Phase	0.3; -1.7	—
SECONDARY Change From Open-label Baseline in Calgary Depression Scale for Schizophrenia (CDSS) at Week 10 Open-label Phase	-0.7	—
SECONDARY Change From Open-label Baseline in CDSS at Week 4 of Double-blind Phase	-0.1; -0.7	—

Summary

To explore the efficacy of SPD489, as adjunctive therapy to a stable dose of atypical antipsychotic medication, on negative symptoms in adult subjects with clinically stable schizophrenia and predominant negative symptoms, as measured by the Scale for the Assessment of Negative Symptoms (SANS).

Eligibility Criteria

Inclusion Criteria

Adults aged 18-55
Clinically stable Schizophrenia and predominant negative symptoms
Taking a stable dose of antipsychotic medication

Exclusion Criteria

Clinically notable positive symptoms defined by PANSS

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Data sourced from ClinicalTrials.gov (NCT00922272). 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.