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Efficacy and Safety Study of SPD489 in Combination With an Antidepressant in the Treatment of Adults With Major Depressive Disorder | Clinical Trials | Clareo Health

COMPLETEDPHASE3

Efficacy and Safety Study of SPD489 in Combination With an Antidepressant in the Treatment of Adults With Major Depressive Disorder

The SPD489-323 Phase 3, Multicenter, Randomized, Double-blind, Parallel-group, Placebo-controlled, Flexible Dose Titration, Efficacy and Safety Study of SPD489 in Combination With an Antidepressant in the Treatment of Adults With Major Depressive Disorder With Inadequate Response to Prospective Treatment With an Antidepressant

NCT01436162•Shire

View on ClinicalTrials.gov

Summary

This study will examine SPD489 in subjects aged 18-65 with major depressive disorder (MDD) who are taking certain types of antidepressants but continue to have residual depression symptoms. Eligible patients will remain on their antidepressant but will be randomized to either receive supplemental SPD489 or placebo (i.e. sugar pill). The purpose of this study is to help answer the following questions: * How safe is SPD489 for the supplemental treatment of depression and what are the side effects that might be related to it? * Can supplemental SPD489 help patients who still have residual depression symptoms while taking an antidepressant? * How much SPD489 should be given to patients with depression who are also taking an antidepressant? * How does SPD489 compare to placebo in depressed patients who are also taking an antidepressant?

Eligibility

Age

18 - 65 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Subject is able to provide written, personally signed, and dated informed consent to participate in the study before completing any study-related procedures.
•2. Subject is between 18 and 65 years of age.
•3. Subject has a primary diagnosis of non-psychotic MDD.
•4. Subject has a MADRS total score \>/=24.
•5. Subject is willing and has an understanding and ability to fully comply with study procedures and restrictions defined in this protocol.
•6. Subject, who is female, must have a negative serum beta human chorionic gonadotropin (B-HCG) pregnancy test and a negative urine pregnancy test and agrees to comply with any applicable contraceptive requirements of the protocol.
•7. Subject is able to swallow a capsule.

Exclusion Criteria

•1. Subject whose current episode of MDD has not responded to an adequate treatment regimen with 2 or more approved single antidepressant agents.
•2. Subject who has a lifetime history of treatment resistant depression, defined as having not responded to adequate treatment with 2 or more treatment regimens.
•3. Subject has a current co-morbid psychiatric disorder that is either controlled with medications prohibited in this study or is uncontrolled and associated with significant symptoms.
•4. Subject has been hospitalized (within the last 12 months) for their current MDD episode.
•5. Subject has a current or lifetime history of attention-deficit/hyperactivity disorder (ADHD).
•6. Subject has a first degree relative that has been diagnosed with bipolar I disorder.
•7. Subject has a recent history (within the last 6 months) of suspected substance abuse or dependence disorder.
•8. Subject is considered a suicide risk, has previously made a suicide attempt within the past 3 years, or is currently demonstrating active suicidal ideation.
•9. Subject has a concurrent chronic or acute illness or unstable medical condition.
•10. Subject has a history of seizures (other than infantile febrile seizures), any tic disorder, or a 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.
+14 more criteria

Locations (101)

ResearchOne, Inc.

Scottsdale, Arizona, United States

K&S Professional Research Services, LLC

Little Rock, Arkansas, United States

ATP Clinical Research, Inc.

Costa Mesa, California, United States

Diligent Clinical Trials

Downey, California, United States

Synergy Clinical Reserach Center of Escondido

Escondido, California, United States

Pacific Research Partners, LLC

Oakland, California, United States

Anderson Clinical Research

Redlands, California, United States

BreakThrough Clinical Trials, LLC

San Bernardino, California, United States

MCB Clinical Research Centers

Colorado Springs, Colorado, United States

Florida Clinical Research Center, LLC

Bradenton, Florida, United States

Key Dates

Start Date

October 19, 2011

Primary Completion Date

December 10, 2013

Completion Date

December 10, 2013

Last Updated

June 9, 2021

Enrollment

1,105

ACTUAL participants

Conditions

Major Depressive Disorder

Interventions

Antidepressant + SPD489 (Lisdexamfetamine dimesylate )

DRUG

Antidepressant + Placebo

DRUG

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RECRUITINGPHASE3

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: June 9, 2021Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Efficacy and Safety Study of SPD489 in Combination With an Antidepressant in the Treatment of Adults With Major Depressive Disorder

Inclusion Criteria

Exclusion Criteria

A Phase 2 Study of Zelquistinel or Placebo for the Reduction of Symptoms of Major Depressive Disorder

A Study of a Deuterated Psilocin Analog (CYB003) in Humans With Major Depressive Disorder

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