SPD489 as Adjunctive Treatment in Adults With Negative Symptoms of Schizophrenia
NCT ID: NCT01234298
Last Updated: 2021-06-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
WITHDRAWN
PHASE3
INTERVENTIONAL
2012-01-27
2014-02-24
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
A Study of the Safety, PK, and Exploratory Efficacy of SP-624 in Acutely Psychotic Adult Subjects With Schizophrenia
NCT04510298
Double Blind, Randomized, 3 Week Inpatient Study To Evaluate The Safety & Efficacy Of PF-02545920 Compared With Placebo
NCT00570063
Safety and Efficacy of Study Drug Versus Placebo for Negative Symptoms of Schizophrenia
NCT00063297
Proof of Concept Study of Cognitive Improvement in Patients With Schizophrenia
NCT00528905
ACP-104 in Acutely Psychotic Subjects With Schizophrenia
NCT00490516
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
SPD489 Low-Dose
SPD489 Low-Dose
SPD489 20, 30, or 40 mg capsules taken once-daily for up to 26 weeks
SPD489 High-Dose
SPD489 High-Dose
SPD489 50, 60, or 70 mg capsules taken once-daily for up to 26 weeks
Placebo
Placebo
Placebo capsule taken once-daily for up to 26 weeks
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
SPD489 Low-Dose
SPD489 20, 30, or 40 mg capsules taken once-daily for up to 26 weeks
SPD489 High-Dose
SPD489 50, 60, or 70 mg capsules taken once-daily for up to 26 weeks
Placebo
Placebo capsule taken once-daily for up to 26 weeks
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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 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
18 Years
55 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Shire
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Study Director
Role: STUDY_DIRECTOR
Takeda
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
SPD489-320
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.