SPD489 as Adjunctive Treatment in Adults With Negative Sy... | NCT01234298

Studies
SPD489 as Adjunctive Treatment in Adults With Negative Symptoms of Schizophrenia

NCT01234298

Sponsor

Shire

Status

Withdrawn

Last Update Posted

Jun 3, 2021Actual

Enrollment

0Actual

Phase

Phase 3

Conditions

Negative Symptoms of Schizophrenia

Interventions

SPD489 Low-Dose
SPD489 High-Dose
Placebo

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Official Title

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 Module

Record Verification Date

May 2021

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Study was discontinued due to non-safety related business prioritization decisions

Expanded Access Info

Start Date

Jan 27, 2012Estimated

Primary Completion Date

Feb 24, 2014Estimated

Completion Date

Feb 24, 2014Estimated

First Submitted Date

Oct 29, 2010

First Submission Date that Met QC Criteria

Nov 2, 2010

First Posted Date

Nov 4, 2010Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 1, 2021

Last Update Posted Date

Jun 3, 2021Actual

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

0Actual

Arms/Interventions Module

Arm Groups

Label	Type	Intervention Names
SPD489 Low-Dose	Experimental	Drug: SPD489 Low-Dose
SPD489 High-Dose	Experimental	Drug: SPD489 High-Dose
Placebo	Placebo Comparator	Drug: Placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
SPD489 Low-Dose	Drug	SPD489 20, 30, or 40 mg capsules taken once-daily for up to 26 weeks	SPD489 Low-Dose

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

55 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Name	Affiliation	Role
Study Director	Takeda	Study Director

Intervention Browse Module

MeSH Terms

ID	Term
D000069478	Lisdexamfetamine Dimesylate

Ancestor Terms

ID	Term
D003913	Dextroamphetamine
D000661	Amphetamine
D000662	Amphetamines
D010627	Phenethylamines

Browse Leaves

Not provided

Browse Branches

Not provided