SPD489 Low Dose and High Dose Ranges When Added to Stable Doses of Antipsychotic Medications in Clinically Stable Adults With Negative Symptoms of Schizophrenia

NCT01760889 | Terminated Phase 3 Results DMC

• 2 other identifiers: SPD489-3352012-003919-57
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 4

Brief Summary

The primary purpose of this study is to determine whether SPD489 low dose range (40, 80, or 100mg) and high dose range (120, 140, or 160mg) are effective in the treatment of Negative Symptoms.

Conditions

Schizophrenia

Outcome Measures

Primary Outcomes (1)

• Change From Baseline in Negative Symptom Assessment (NSA-16) Total Score at 26 Weeks

  Baseline and 26 weeks

Secondary Outcomes (13)

• Change From Baseline in the Personal and Social Performance (PSP) Scale Score at 26 Weeks

  Baseline and 26 weeks

• Change From Baseline in Simpson Angus Scale (SAS) Total Score at 26 Weeks

  Baseline and 26 weeks

• Change From Baseline in Barnes Akathisia Scale (BAS) Total Score at 26 Weeks

  Baseline and 26 weeks

• Change From Baseline in the Abnormal Involuntary Movement Scale (AIMS) at 26 Weeks

  Baseline and 26 weeks

• Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Scores at 26 Weeks

  Baseline and 26 weeks

Study Arms (3)

SPD489 Low Dose Range

EXPERIMENTAL

Drug: SPD489 low dose range (40mg, 80mg, and 100mg)

SPD489 High Dose Range

EXPERIMENTAL

Drug: SPD489 high dose range (120mg, 140mg and 160mg)

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

SPD489 low dose range (40mg, 80mg, and 100mg) DRUG

Capsule, dose titration, * 40 mg capsule once-daily for 1 week; then * 80 mg capsule once-daily for 4 weeks; then, * 100 mg capsule once-daily (if unable to tolerate 100 mg dose between weeks 5 to 6, then dose to be decreased to 80 mg once-daily for the remaining 21 weeks; * if able to tolerate 100 mg dose then will continue on 100 mg capsule once-daily for 21 weeks

Also known as: lisdexamfetamine dimesylate, LDX, Vyvanse

SPD489 Low Dose Range

SPD489 high dose range (120mg, 140mg and 160mg) DRUG

Capsule, dose titration, * 40 mg capsule once-daily for 1 week; then * 80 mg capsule once daily for 1 week; then * 120 mg capsule once-daily for 1 week, then, * 140 mg capsule once-daily for 2 weeks, then * 160 mg once capsule once-daily (if unable to tolerate 160 mg dose between weeks 5 to 6, then dose to be decreased to 140 mg once-daily for the remaining 21 weeks; * if able to tolerate 160 mg dose then will continue on 160 mg capsule once-daily for 21 weeks

Also known as: lisdexamfetamine dimesylate, LDX, Vyvanse

SPD489 High Dose Range

Placebo DRUG

One capsule a day for 26 weeks

Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \- 18 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 days

Sponsors & Collaborators

• Shire: lead

Study Sites (4)

Galiz Research

Miami Springs, Florida, 33166, United States

Location

Psychiatric Care and Research Center

O'Fallon, Missouri, 63368, United States

Location

St. Charles Psychiatric Associates

Saint Charles, Missouri, 63304, United States

Location

CRI Lifetree

Philadelphia, Pennsylvania, 19139, United States

Location

MeSH Terms

Conditions

Schizophrenia

Interventions

Lisdexamfetamine Dimesylate

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Dextroamphetamine; Amphetamine; Amphetamines; Phenethylamines; Ethylamines; Amines; Organic 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: January 2, 2013
• First Posted: January 4, 2013
• Study Start: February 1, 2013
• 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 (4)