Efficacy and Safety Study of 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:
NCT01436162
First received: September 15, 2011
Last updated: June 6, 2014
Last verified: December 2013

September 15, 2011
June 6, 2014
October 2011
December 2013   (final data collection date for primary outcome measure)
Change from Baseline in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score at up to 8 Weeks [ Time Frame: Baseline and up to 8 weeks ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01436162 on ClinicalTrials.gov Archive Site
  • Change from Baseline in Sheehan Disability Scale (SDS) Total Score at up to 8 Weeks [ Time Frame: Baseline and up to 8 weeks ] [ Designated as safety issue: No ]
  • Columbia Suicide Severity Rating Scale (C-SSRS) [ Time Frame: up to 8 weeks ] [ Designated as safety issue: Yes ]
  • Percent of Participants Achieving a 25% Response on the MADRS [ Time Frame: up to 8 weeks ] [ Designated as safety issue: No ]
  • Percent of Participants Achieving a 50% Response on the MADRS [ Time Frame: up to 8 weeks ] [ Designated as safety issue: No ]
  • Percent of Participants Achieving Remission on the MADRS [ Time Frame: up to 8 weeks ] [ Designated as safety issue: No ]
  • Change from Baseline Over Time in MADRS Total Score [ Time Frame: up to 8 weeks ] [ Designated as safety issue: No ]
  • Abbreviated Brief Assessment of Cognition Affective Disorders (ABAC-A). [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
  • Short Form-12 Health Survey V2 (SF-12V2) [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
  • EuroQoL Group 5-Dimension Self-Report Questionnaire (EQ-5D-5L index score) [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
  • Changes in Sexual Functioning Questionnaire - 14 item Scale (CSFQ-14) [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
  • Clinical Global Impressions - Severity of Illness (CGI-S) [ Time Frame: up to 8 weeks ] [ Designated as safety issue: No ]
  • Clinical Global Impressions - Global Improvement (CGI-I) [ Time Frame: up to 8 weeks ] [ Designated as safety issue: No ]
  • Global Fatigue Index (GFI) in the Multidimensional Assessment of Fatigue (MAF) [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
  • Amphetamine Cessation Symptom Assessment (ACSA) [ Time Frame: up to 8 weeks ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
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

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?
Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Major Depressive Disorder
  • Drug: Antidepressant + SPD489 (Lisdexamfetamine dimesylate )
    Antidepressant (either escitalopram oxalate, sertraline hydrochloride, venlafaxine hydrochloride extended release or duloxetine hydrochloride) oral, once daily + SPD489 (oral, 20, 30, 50 or 70 mg, once daily) for 8 weeks
    Other Name: Vyvanse
  • Drug: Antidepressant + Placebo
    Antidepressant (either escitalopram oxalate, sertraline hydrochloride, venlafaxine hydrochloride extended release or duloxetine hydrochloride) oral, once daily + Placebo (oral, once daily) for 8 weeks
  • Experimental: Antidepressant + SPD489
    Intervention: Drug: Antidepressant + SPD489 (Lisdexamfetamine dimesylate )
  • Placebo Comparator: Antidepressant + Placebo
    Intervention: Drug: Antidepressant + Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
1105
December 2013
December 2013   (final data collection date for primary outcome measure)

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.
  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.
  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.
  16. Subject has a history of moderate to severe hypertension.
  17. Current use of any other medications (including over-the-counter [OTC], herbal or homeopathic preparations) that have central nervous system effects.
  18. Subject has the potential 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 (ECT) 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, hypersensitivity, or contraindications to their assigned antidepressant treatments (escitalopram oxalate, sertraline HCl, venlafaxine HCl extended release, or duloxetine HCl).
  22. Subject has a positive urine drug result.
  23. Subject has a body mass index (BMI) of <18.5 or >40.
  24. Subject is female and is pregnant or nursing.
Both
18 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
United States,   Belgium,   Czech Republic,   Estonia,   Finland,   Germany,   Hungary,   Poland,   Romania,   South Africa,   Sweden
 
NCT01436162
SPD489-323, 2011-003006-25
Not Provided
Shire
Shire
Not Provided
Principal Investigator: Madhukar H Trivedi, M.D. University of Texas Southwestern Medical School, Dallas, Texas 75235
Shire
December 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP