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Trial record 6 of 1020 for:    "Depressive Disorder" [DISEASE] AND Rating AND Major Depressive Disorder AND Antidepressive Agents

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

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ClinicalTrials.gov Identifier: NCT01435759
Recruitment Status : Completed
First Posted : September 19, 2011
Results First Posted : February 19, 2015
Last Update Posted : January 8, 2019
Sponsor:
Information provided by (Responsible Party):
Shire

Tracking Information
First Submitted Date  ICMJE September 15, 2011
First Posted Date  ICMJE September 19, 2011
Results First Submitted Date  ICMJE February 3, 2015
Results First Posted Date  ICMJE February 19, 2015
Last Update Posted Date January 8, 2019
Actual Study Start Date  ICMJE May 31, 2011
Actual Primary Completion Date January 17, 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 3, 2015)
Change in Montgomery-Ǻsberg Depression Rating Scale (MADRS) Total Score From Augmentation Baseline (Week 8) to Week 16 (Double-blind Phase, Dose Response Evaluable Set) [ Time Frame: Augmentation Baseline (Week 8) to Week 16 ]
MADRS is a validated, 10-item rating scale with each item being scored on a scale from 0-6 with a total score ranging from 0-60. Lower scores indicate a decreased severity of depression. CHange in MADRS total score in Augmentsion Baseline to Week 16.
Original Primary Outcome Measures  ICMJE
 (submitted: September 16, 2011)
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 ]
Change History Complete list of historical versions of study NCT01435759 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: February 3, 2015)
  • Change in Average Systolic Blood Pressure From Augmentation Baseline (Week 8) to Week 16 [ Time Frame: From Augmentation Baseline (Week 8) to Week 16 ]
  • Change in Average Diastolic Blood Pressure From Augmentation Baseline (Week 8) to Week 16 [ Time Frame: From Augmentation Baseline (Week 8) to Week 16 ]
  • Change in Average Pulse Rate From Augmentation Baseline (Week 8) to Week 16 [ Time Frame: From Augmentation Baseline (Week 8) to Week 16 ]
Original Secondary Outcome Measures  ICMJE
 (submitted: September 16, 2011)
  • Change from Augmentation Baseline in Systolic Blood Pressure at up to 8 Weeks [ Time Frame: Augmentation baseline and up to 8 weeks ]
  • Change from Augmentation Baseline in Diastolic Blood Pressure at up to 8 Weeks [ Time Frame: Augmentation baseline and up to 8 weeks ]
  • Change from Augmentation Baseline in Pulse Rate at up to 8 Weeks [ Time Frame: Augmentation baseline and up to 8 weeks ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE SPD489 in Combination With an Antidepressant in the Treatment of Adults With Major Depressive Disorder
Official Title  ICMJE 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
Brief 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. 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?
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Major Depressive Disorder
Intervention  ICMJE
  • Drug: Antidepressant + SPD489 (Lisdexamfetamine dimesylate) 10 mg
    Antidepressant + SPD489 oral, 10 mg, once daily for 8 weeks
    Other Name: Vyvanse
  • Drug: Antidepressant + SPD489 (Lisdexamfetamine dimesylate) 30 mg
    Antidepressant + SPD489 oral, 30 mg, once daily for 8 weeks
    Other Name: Vyvanse
  • Drug: Antidepressant + SPD489 (Lisdexamfetamine dimesylate) 50 mg
    Antidepressant + SPD489 oral, 50 mg, once daily for 8 weeks
    Other Name: Vyvanse
  • Drug: Antidepressant + SPD489 (Lisdexamfetamine dimesylate) 70 mg
    Antidepressant + SPD489 oral, 70 mg, once daily for 8 weeks
    Other Name: Vyvanse
  • Drug: Antidepressant + Placebo
    oral, once daily for 8 weeks
Study Arms  ICMJE
  • Experimental: Antidepressant + SPD489 10 mg
    Intervention: Drug: Antidepressant + SPD489 (Lisdexamfetamine dimesylate) 10 mg
  • Experimental: Antidepressant + SPD489 30 mg
    Intervention: Drug: Antidepressant + SPD489 (Lisdexamfetamine dimesylate) 30 mg
  • Experimental: Antidepressant + SPD489 50 mg
    Intervention: Drug: Antidepressant + SPD489 (Lisdexamfetamine dimesylate) 50 mg
  • Experimental: Antidepressant + SPD489 70 mg
    Intervention: Drug: Antidepressant + SPD489 (Lisdexamfetamine dimesylate) 70 mg
  • Placebo Comparator: Antidepressant + Placebo
    Intervention: Drug: Antidepressant + Placebo
Publications * Richards C, Iosifescu DV, Mago R, Sarkis E, Reynolds J, Geibel B, Dauphin M. A randomized, double-blind, placebo-controlled, dose-ranging study of lisdexamfetamine dimesylate augmentation for major depressive disorder in adults with inadequate response to antidepressant therapy. J Psychopharmacol. 2017 Sep;31(9):1190-1203. doi: 10.1177/0269881117722998. Epub 2017 Aug 31.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 11, 2014)
1197
Original Estimated Enrollment  ICMJE
 (submitted: September 16, 2011)
1134
Actual Study Completion Date  ICMJE January 17, 2014
Actual Primary Completion Date January 17, 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Argentina,   Australia,   Chile,   United Kingdom,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01435759
Other Study ID Numbers  ICMJE SPD489-209
2011-003615-28 ( EudraCT Number )
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Shire
Study Sponsor  ICMJE Shire
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Study Director Shire
PRS Account Shire
Verification Date December 2018

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