Adjunctive Lisdexamfetamine (LDX) in Bipolar Depression

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01131559
Recruitment Status : Terminated (Sponsor halted study.)
First Posted : May 27, 2010
Last Update Posted : March 5, 2014
University of Cincinnati
Information provided by (Responsible Party):
Lindner Center of HOPE

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

Condition or disease Intervention/treatment Phase
Bipolar Depression Drug: Lisdexamfetamine Drug: Placebo control Phase 3

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Adjunctive Lisdexamfetamine in Bipolar Depression
Study Start Date : January 2010
Actual Primary Completion Date : February 2014
Actual Study Completion Date : February 2014

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Active Comparator: Lisdexamfetamine
Drug: Lisdexamfetamine
Oral; 20-70mg/day
Other Name: Vyvanse
Placebo Comparator: Placebo
Drug: Placebo control
Oral; 20-70mg/day
Other Name: Sugar pill, fake pill with no active medication

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01131559

United States, Ohio
Lindner Center of HOPE
Mason, Ohio, United States, 45040
Sponsors and Collaborators
Lindner Center of HOPE
University of Cincinnati

Additional Information:
Responsible Party: Lindner Center of HOPE Identifier: NCT01131559     History of Changes
Other Study ID Numbers: Adjunctive LDX in BP
First Posted: May 27, 2010    Key Record Dates
Last Update Posted: March 5, 2014
Last Verified: March 2014

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

Additional relevant MeSH terms:
Depressive Disorder
Bipolar Disorder
Behavioral Symptoms
Mood Disorders
Mental Disorders
Bipolar and Related Disorders
Lisdexamfetamine Dimesylate
Central Nervous System Stimulants
Physiological Effects of Drugs
Dopamine Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Dopamine Agents
Neurotransmitter Agents