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Adjunctive Lisdexamfetamine (LDX) in Bipolar Depression

This study is currently recruiting participants.
Verified May 2013 by Lindner Center of HOPE
Sponsor:
Collaborators:
Shire Development LLC
University of Cincinnati
Information provided by (Responsible Party):
Lindner Center of HOPE
ClinicalTrials.gov Identifier:
NCT01131559
First received: March 19, 2010
Last updated: May 8, 2013
Last verified: May 2013
History of Changes
  Purpose

The specific aim of this study is to evaluate the efficacy and tolerability of lisdexamfetamine in the adjunctive treatment of bipolar disorder.


Condition Intervention Phase
Bipolar
Depression
 Drug: Lisdexamfetamine
Drug: Placebo control
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Adjunctive Lisdexamfetamine in Bipolar Depression

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Lindner Center of HOPE:

Primary Outcome Measures:
  • Change in MADRS score [ Time Frame: 30-36 months ] [ Designated as safety issue: Yes ]
    The primary efficacy variable is baseline-to-endpoint change in Montgomery-Asberg Depression Rating Scale (MADRS) score.


Estimated Enrollment: 50
Study Start Date: January 2010
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: August 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Lisdexamfetamine
Drug
 Drug: Lisdexamfetamine
Oral; 20-70mg/day
Other Name: Vyvanse
Placebo Comparator: Placebo
Drug
 Drug: Placebo control
Oral; 20-70mg/day
Other Name: Sugar pill, fake pill with no active medication

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Subjects will meet DSM-IV-TR criteria bipolar I or II disorder,

Exclusion Criteria:

  • Women who are pregnant, lactating, or of childbearing potential who are not using adequate contraceptive measures.
  • Clinically unstable medical disease, including cardiovascular, hepatic, renal, gastrointestinal, pulmonary, metabolic, endocrine or other systemic disease. Subjects should be biochemically euthyroid to enter the study.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01131559

Contacts
Contact: Brian Martens, MS 513-536-0720 brian.martens@lindnercenter.org

Locations
United States, Ohio
Lindner Center of HOPE Recruiting
Mason, Ohio, United States, 45040
Contact: Brian Martens, MS     513-536-0720     brian.martens@lindnercenter.org    
Principal Investigator: Susan L McElroy, MD            
Sponsors and Collaborators
Lindner Center of HOPE
Shire Development LLC
University of Cincinnati
  More Information

Additional Information:
Link to facility where study is conducted  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Lindner Center of HOPE
ClinicalTrials.gov Identifier: NCT01131559     History of Changes
Other Study ID Numbers: Adjunctive LDX in BP
Study First Received: March 19, 2010
Last Updated: May 8, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Lindner Center of HOPE:
bipolar disorder
manic depression
depression
Bipolar I or II

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

ClinicalTrials.gov processed this record on May 23, 2013