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SPD489 Adult Major Depressive Disorder (MDD) Open-label Safety and Tolerability Rollover Extension Study

This study is enrolling participants by invitation only.
Sponsor:
Information provided by (Responsible Party):
Shire Development LLC
ClinicalTrials.gov Identifier:
NCT01436175
First received: September 15, 2011
Last updated: April 26, 2013
Last verified: April 2013
History of Changes
  Purpose

This study is an optional continuation of previous short-term adult major depressive disorder (MDD) augmentation studies. Patients may only take part in this long-term, open-label research study if they completed a previous double-blind MDD augmentation study using SPD489.


Condition Intervention Phase
Major Depressive Disorder
 Drug: SPD489 (Lisdexamfetamine dimesylate) + Antidepressant
 Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase 3, Open-label, Multicenter, 12-month Extension Safety and Tolerability Study of SPD489 in Combination With an Antidepressant in the Treatment of Adults With Major Depressive Disorder With Residual Symptoms or Inadequate Response Following Treatment With an Antidepressant

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Shire Development LLC:

Primary Outcome Measures:
  • Columbia-Suicide Severity Rating Scale (C-SSRS) [ Time Frame: up to 52 weeks ] [ Designated as safety issue: Yes ]
  • Change From Baseline in Systolic Blood Pressure at up to 52 Weeks [ Time Frame: Baseline and up to 52 weeks ] [ Designated as safety issue: Yes ]
  • Change From Baseline in Diastolic Blood Pressure at up to 52 Weeks [ Time Frame: Baseline and up to 52 weeks ] [ Designated as safety issue: Yes ]
  • Change From Baseline in Pulse Rate at up to 52 Weeks [ Time Frame: Baseline and up to 52 weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Change from Baseline in Sheehan Disability Scale (SDS) Total Score at up to 52 Weeks [ Time Frame: Baseline and up to 52 weeks ] [ Designated as safety issue: No ]
  • Clinical Global Impressions - Global Improvement (CGI-I) [ Time Frame: up to 52 weeks ] [ Designated as safety issue: No ]
  • Short Form-12 Health Survey V2 (SF-12V2) [ Time Frame: up to 52 weeks ] [ Designated as safety issue: No ]
  • EuroQoL Group 5-Dimension Self Report Questionnaire (EQ-5D-5L index score) [ Time Frame: up to 52 weeks ] [ Designated as safety issue: No ]
  • Quick Inventory of Depressive Symptomatology - Self Report (QIDS-SR) [ Time Frame: up to 52 weeks ] [ Designated as safety issue: No ]
  • Quality of Life Enjoyment Satisfaction Questionnaire Short Form (Q-LES-Q-SF) [ Time Frame: up to 52 weeks ] [ Designated as safety issue: No ]
  • Changes in Sexual Functioning Questionnaire - 14 item Scale (CSFQ-14) [ Time Frame: up to 52 weeks ] [ Designated as safety issue: No ]
  • Patient Resource Utilization Questionnaire (PRUQ) [ Time Frame: up to 52 weeks ] [ Designated as safety issue: No ]
  • Amphetamine Cessation Symptom Assessment (ACSA) [ Time Frame: up to 52 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 1700
Study Start Date: February 2012
Estimated Study Completion Date: January 2015
Estimated Primary Completion Date: January 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: SPD489 + Antidepressant Drug: SPD489 (Lisdexamfetamine dimesylate) + Antidepressant
SPD489 20mg, 30mg, 50mg, or 70mg + Antidepressant (either escitalopram oxalate, sertraline hydrochloride, venlafaxine hydrochloride extended release or duloxetine hydrochloride) oral, once daily for 52 weeks
Other Name: Vyvanse, LDX

  Eligibility

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

Inclusion Criteria:

  • Subject has completed 1 of the respective short-term antecedent SPD489 MDD studies and did not experience any clinically significant AEs in the antecedent study that would preclude exposure to SPD489.

Exclusion Criteria:

  • Subject has any current co-morbid Axis I or Axis II psychiatric disorder (including a lifetime history of psychosis) which was not present or recognized at entry into the antecedent study or has a concurrent chronic or acute illness or unstable medical condition that may deteriorate that could confound the results of safety assessments, increase risk to the subject or lead to difficulty complying with the protocol
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01436175

  Show 187 Study Locations
Sponsors and Collaborators
Shire Development LLC
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 Development LLC
ClinicalTrials.gov Identifier: NCT01436175     History of Changes
Other Study ID Numbers: SPD489-329
Study First Received: September 15, 2011
Last Updated: April 26, 2013
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on May 22, 2013