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Efficacy Study of Lisdexamfetamine to Treat Bipolar Depression

This study has been terminated.
(Enrollment goals not met)
Sponsor:
ClinicalTrials.gov Identifier:
NCT01093963
First Posted: March 26, 2010
Last Update Posted: September 2, 2015
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.
Collaborators:
Shire
University of Cincinnati
Information provided by (Responsible Party):
Lindner Center of HOPE
  Purpose
The specific aim of this study is to evaluate the efficacy and tolerability of a stimulant (lisdexamfetamine) in the adjunctive treatment of bipolar disorder.

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

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Adjunctive Lisdexamfetamine in Bipolar Depression

Resource links provided by NLM:


Further study details as provided by Lindner Center of HOPE:

Primary Outcome Measures:
  • Change in the Montgomery-Asberg Depression Rating Scale [ Time Frame: 30-36 months ]
    Efficacy will be assessed by measuring the baseline-to-endpoint change in the Montgomery-Asberg Depression Rating Scale (MADRS)


Enrollment: 25
Study Start Date: January 2010
Study Completion Date: February 2014
Primary Completion Date: February 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Lisdexamfetamine
Drug
Drug: Lisdexamfetamine
oral; 20-70mg/day
Placebo Comparator: Placebo
Drug
Drug: Placebo
oral; 20-70mg/day

  Eligibility

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
Criteria

Inclusion Criteria:

  • Men and women, through the ages of 18 and 55 years, inclusive.

Exclusion Criteria:

  • Women who are pregnant, lactating, or of childbearing potential who are not using adequate contraceptive measures.
  • Subjects who are displaying clinically significant homicidality or suicidality
  • 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
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 ClinicalTrials.gov identifier (NCT number): NCT01093963


Locations
United States, Ohio
Lindner Center of HOP
Mason, Ohio, United States, 45040
Sponsors and Collaborators
Lindner Center of HOPE
Shire
University of Cincinnati
  More Information

Publications:
Responsible Party: Lindner Center of HOPE
ClinicalTrials.gov Identifier: NCT01093963     History of Changes
Other Study ID Numbers: LDX BP
First Submitted: March 25, 2010
First Posted: March 26, 2010
Last Update Posted: September 2, 2015
Last Verified: August 2015

Additional relevant MeSH terms:
Depression
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