SPD489 in Combination With an Antidepressant in the Treatment of Adults With Major Depressive Disorder

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Shire
ClinicalTrials.gov Identifier:
NCT01435759
First received: September 15, 2011
Last updated: June 6, 2014
Last verified: February 2014
  Purpose

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. 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 SPD489 help patients with depression who are also 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?

Condition Intervention Phase
Major Depressive Disorder
Drug: Antidepressant + SPD489 (Lisdexamfetamine dimesylate) 10 mg
Drug: Antidepressant + SPD489 (Lisdexamfetamine dimesylate) 30 mg
Drug: Antidepressant + SPD489 (Lisdexamfetamine dimesylate) 50 mg
Drug: Antidepressant + SPD489 (Lisdexamfetamine dimesylate) 70 mg
Drug: Antidepressant + Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase 2, Multicenter, Double- Blind, Parallel-group, Randomized, Placebo-controlled, Forced-dose Titration, Dose-ranging 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

Resource links provided by NLM:


Further study details as provided by Shire:

Primary Outcome Measures:
  • Change from Augmentation Baseline in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score at up to 8 Weeks [ Time Frame: Augmentation baseline and up to 8 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change from Augmentation Baseline in Systolic Blood Pressure at up to 8 Weeks [ Time Frame: Augmentation baseline and up to 8 weeks ] [ Designated as safety issue: Yes ]
  • Change from Augmentation Baseline in Diastolic Blood Pressure at up to 8 Weeks [ Time Frame: Augmentation baseline and up to 8 weeks ] [ Designated as safety issue: Yes ]
  • Change from Augmentation Baseline in Pulse Rate at up to 8 Weeks [ Time Frame: Augmentation baseline and up to 8 weeks ] [ Designated as safety issue: Yes ]

Enrollment: 1197
Study Start Date: October 2011
Study Completion Date: January 2014
Primary Completion Date: January 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Antidepressant + SPD489 10 mg Drug: Antidepressant + SPD489 (Lisdexamfetamine dimesylate) 10 mg
Antidepressant + SPD489 oral, 10 mg, once daily for 8 weeks
Other Name: Vyvanse
Experimental: Antidepressant + SPD489 30 mg Drug: Antidepressant + SPD489 (Lisdexamfetamine dimesylate) 30 mg
Antidepressant + SPD489 oral, 30 mg, once daily for 8 weeks
Other Name: Vyvanse
Experimental: Antidepressant + SPD489 50 mg Drug: Antidepressant + SPD489 (Lisdexamfetamine dimesylate) 50 mg
Antidepressant + SPD489 oral, 50 mg, once daily for 8 weeks
Other Name: Vyvanse
Experimental: Antidepressant + SPD489 70 mg Drug: Antidepressant + SPD489 (Lisdexamfetamine dimesylate) 70 mg
Antidepressant + SPD489 oral, 70 mg, once daily for 8 weeks
Other Name: Vyvanse
Placebo Comparator: Antidepressant + Placebo Drug: Antidepressant + Placebo
oral, once daily for 8 weeks

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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 18-65 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 (HCG) pregnancy test and a negative urine pregnancy test and agrees to comply with any applicable contraceptive requirements.
  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.
  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 comorbid 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.
  11. Subject has known history of symptomatic cardiovascular disease, advanced arteriosclerosis, structural cardiac abnormality, cardiomyopathy, serious heart rhythm abnormalities, coronary artery disease, or other serious cardiac problems that may place them at increased vulnerability to the sympathomimetic effects of a stimulant medication.
  12. Subject has a history of thyroid disorder that has not been stabilized on thyroid medication or treatment within 3 months prior to the Screening Visit.
  13. Subject has a known family history of sudden cardiac death or ventricular arrhythmia.
  14. Subject has glaucoma.
  15. Subject has any clinically significant ECG or clinical laboratory abnormalities at the Screening Visit.
  16. Subject has a history of moderate to severe hypertension.
  17. Current use of any other medication (including over-the-counter [OTC], herbal or homeopathic preparations) that has central nervous system effects.
  18. Subject has the potential to need to initiate or modify frequency of psychotherapy or to continue or initiate other treatments for depression, outside of those allowed in this protocol.
  19. Subject has had electroconvulsive therapy for the current depressive episode 3 months prior to the Lead-in Baseline Visit.
  20. The subject has a known or suspected intolerance or hypersensitivity to the investigational product.
  21. The subject has a known or suspected intolerance or hypersensitivity to any of the possible antidepressant treatments (escitalopram oxalate or venlafaxine HCL extended release.
  22. Subject has a positive urine drug result.
  23. Subject has a body mass index of <18.5 or >40.
  24. Subject is female and is pregnant or nursing.
  25. Subject has participated in another clinical study involving SPD489/NRP104 or has previously used commercial lisdexamfetamine dimesylate.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01435759

  Show 82 Study Locations
Sponsors and Collaborators
Shire
Investigators
Principal Investigator: Madhukar H Trivedi, M.D. University of Texas Southwestern Medical School, Dallas, Texas 75235
  More Information

No publications provided

Responsible Party: Shire
ClinicalTrials.gov Identifier: NCT01435759     History of Changes
Other Study ID Numbers: SPD489-209, 2011-003615-28
Study First Received: September 15, 2011
Last Updated: June 6, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Depressive Disorder, Major
Depressive Disorder
Depression
Disease
Mood Disorders
Mental Disorders
Behavioral Symptoms
Pathologic Processes
Antidepressive Agents
Dextroamphetamine
Psychotropic Drugs
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Central Nervous System Stimulants
Physiological Effects of Drugs
Dopamine Uptake Inhibitors
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Uptake Inhibitors

ClinicalTrials.gov processed this record on September 22, 2014