SPD489 as Adjunctive Treatment in Adults With Negative Symptoms of Schizophrenia

A Phase 3 Multicenter, Randomized, Double-blind, Parallel-group, Placebo-controlled Study to Evaluate the Efficacy, Safety, and Tolerability of Low- and High-dose Range Groups of SPD489 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

Withdrawn

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01234298

Acronym

NSS

Enrollment

Registered

2010-11-04

Start date

2012-01-27

Completion date

2014-02-24

Last updated

2021-06-03

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

Conditions

Negative Symptoms of Schizophrenia

Brief summary

To assess the safety and efficacy of SPD489 low-dose and high-dose treatment groups to placebo when given as adjunctive therapy to antipsychotic medication in clinically stable adults with persistent predominant negative symptoms of schizophrenia.

Interventions

DRUGSPD489 Low-Dose

SPD489 20, 30, or 40 mg capsules taken once-daily for up to 26 weeks

DRUGSPD489 High-Dose

SPD489 50, 60, or 70 mg capsules taken once-daily for up to 26 weeks

DRUGPlacebo

Placebo capsule taken once-daily for up to 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 55 Years

Healthy volunteers

Inclusion criteria

* Subject has diagnosis of schizophrenia for at least 2 years * Subject has persistent predominant negative symptoms * Subject has 2 or more persistent predominant negative symptoms (affective flattening, alogia, avolition apathy, and anhedonia-asociality) determined to have been present for at least 6 months * Subject is maintained on antipsychotic monotherapy or polytherapy with no more than 2 antipsychotic medications * Subject has been clinically stable and is in the non-acute phase of illness

Exclusion criteria

* Subject has clinically notable positive symptoms * Subject is considered to be treatment refractory * Subject has current history of substance abuse/dependance * Subject is considered a suicide risk or risk to harm others

Design outcomes

Primary

Measure	Time frame
Negative Symptom Assessment (NSA-16) total score	up to 26 weeks

Secondary

Measure	Time frame
Positive and Negative Syndrome Scale (PANSS)	up to 26 weeks

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026