NCT01738698

Brief Summary

The primary purpose of this study is to determine whether SPD489 40 mg, 100 mg, and 160 mg are effective and safe in the treatment of Negative Symptoms of Schizophrenia (NSS).

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
4

participants targeted

Target at below P25 for phase_3 schizophrenia

Timeline
Completed

Started Nov 2012

Shorter than P25 for phase_3 schizophrenia

Geographic Reach
1 country

1 active site

Status
terminated

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

Study Start

First participant enrolled

November 1, 2012

Completed
27 days until next milestone

First Submitted

Initial submission to the registry

November 28, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 30, 2012

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2013

Completed
1.2 years until next milestone

Results Posted

Study results publicly available

May 29, 2014

Completed
Last Updated

June 22, 2021

Status Verified

May 1, 2021

Enrollment Period

5 months

First QC Date

November 28, 2012

Results QC Date

May 1, 2014

Last Update Submit

May 29, 2021

Conditions

Schizophrenia

Outcome Measures

Primary Outcomes (1)

  • Change From Baseline in Negative Symptom Assessment - 16-item (NSA-16) Total Score at 12 Weeks

    Baseline and 12 weeks

Secondary Outcomes (14)

  • Change From Baseline in the Personal and Social Performance Scale (PSP) Score at 12 Weeks

    Baseline and 12 weeks

  • Change From Baseline in Simpson Angus Scale (SAS) Total Score at 12 Weeks

    Baseline and 12 weeks

  • Change From Baseline in Barnes Akathisia Scale (BAS) Total Score at 12 Weeks

    Baseline and 12 weeks

  • Change From Baseline in Amphetamine Cessation Symptom Assessment (ACSA) Total Score at 12 Weeks

    Baseline and 12 weeks

  • Change From Baseline in the Abnormal Involuntary Movement Scale (AIMS) at 12 Weeks

    Baseline and 12 weeks

  • +9 more secondary outcomes

Study Arms (4)

SPD489 40mg

EXPERIMENTAL
Drug: SPD489 40mg

SPD489 100mg

EXPERIMENTAL
Drug: SPD489 100mg

SPD489 160mg

EXPERIMENTAL
Drug: SPD489 160mg

Placebo

PLACEBO COMPARATOR
Drug: Placebo

Interventions

SPD489 40mgDRUG

Oral administration of 40 mg once-daily for up to 12 weeks

Also known as: lisdexamfetamine dimesylate, LDX, Vyvanse
SPD489 40mg
SPD489 100mgDRUG

Oral administration of 100 mg once-daily for up to 12 weeks

Also known as: lisdexamfetamine dimesylate, LDX, Vyvanse
SPD489 100mg
SPD489 160mgDRUG

Oral administration of 160 mg once-daily for up to 12 weeks

Also known as: lisdexamfetamine dimesylate, LDX, Vyvanse
SPD489 160mg
PlaceboDRUG

Oral administration once-daily for 12 weeks

Placebo

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • to 65 years of age
  • Has a reliable informant (eg, family member, social worker, caseworker, or nurse that spends \>4 hours/week with the subject)
  • Fixed home/place of residence and can be reached by telephone
  • On a stable dose of antipsychotic medications
  • Able to swallow capsules

You may not qualify if:

  • Taking lithium, carbamazepine, lamotrigine, gabapentin, cholinesterase inhibitors, modafinil, or other stimulants such as methylphenidate and other amphetamine products
  • Treated with clozapine in past 30 days
  • Lifetime history of stimulant, cocaine, or amphetamine abuse or dependence
  • History of seizures (other than infantile febrile seizures), any tic disorder, or current diagnosis and/or a known family history of Tourette's Disorder, serious neurological disease, history of significant head trauma, dementia, cerebrovascular disease, Parkinson's disease, or intracranial lesions
  • Uncontrolled hypertension
  • History of thyroid disorder that has not been stabilized on thyroid medication
  • Glaucoma
  • Pregnant or nursing
  • Subject has received an investigational product or participated in a clinical study within 30 day

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hills Clinical Research

Irving, Texas, 75062, United States

Location

MeSH Terms

Conditions

Schizophrenia

Interventions

Lisdexamfetamine Dimesylate

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic DisordersMental Disorders

Intervention Hierarchy (Ancestors)

DextroamphetamineAmphetamineAmphetaminesPhenethylaminesEthylaminesAminesOrganic Chemicals

Limitations and Caveats

Study was discontinued due to non-safety related business prioritization decisions. No subjects were randomized

Results Point of Contact

Title
Study Director
Organization
Shire
ClinicalTransparency@shire.com
+1 866 842 5335

Study Officials

  • Study Director

    Takeda

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

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

November 28, 2012

First Posted

November 30, 2012

Study Start

November 1, 2012

Primary Completion

April 1, 2013

Study Completion

April 1, 2013

Last Updated

June 22, 2021

Results First Posted

May 29, 2014

Record last verified: 2021-05

Locations

US(1)