NCT01234298

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.

Trial Health

15
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Jan 2012

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 29, 2010

Completed
6 days until next milestone

First Posted

Study publicly available on registry

November 4, 2010

Completed
1.2 years until next milestone

Study Start

First participant enrolled

January 27, 2012

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 24, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 24, 2014

Completed
Last Updated

June 3, 2021

Status Verified

May 1, 2021

Enrollment Period

2.1 years

First QC Date

October 29, 2010

Last Update Submit

June 1, 2021

Conditions

Negative Symptoms of Schizophrenia

Outcome Measures

Primary Outcomes (1)

  • Negative Symptom Assessment (NSA-16) total score

    up to 26 weeks

Secondary Outcomes (1)

  • Positive and Negative Syndrome Scale (PANSS)

    up to 26 weeks

Study Arms (3)

SPD489 Low-Dose

EXPERIMENTAL
Drug: SPD489 Low-Dose

SPD489 High-Dose

EXPERIMENTAL
Drug: SPD489 High-Dose

Placebo

PLACEBO COMPARATOR
Drug: Placebo

Interventions

SPD489 Low-DoseDRUG

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

Also known as: Vyvanse, Lisdexamfetamine dimesylate, LDX
SPD489 Low-Dose
SPD489 High-DoseDRUG

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

Also known as: Vyvanse, Lisdexamfetamine dimesylate, LDX
SPD489 High-Dose
PlaceboDRUG

Placebo capsule taken once-daily for up to 26 weeks

Placebo

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Interventions

Lisdexamfetamine Dimesylate

Intervention Hierarchy (Ancestors)

DextroamphetamineAmphetamineAmphetaminesPhenethylaminesEthylaminesAminesOrganic Chemicals

Study Officials

  • Study Director

    Takeda

    STUDY DIRECTOR
0

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 29, 2010

First Posted

November 4, 2010

Study Start

January 27, 2012

Primary Completion

February 24, 2014

Study Completion

February 24, 2014

Last Updated

June 3, 2021

Record last verified: 2021-05