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Adjunctive Lisdexamfetamine (LDX) in Bipolar Depression

This study has been terminated.
(Sponsor halted study.)
University of Cincinnati
Information provided by (Responsible Party):
Lindner Center of HOPE Identifier:
First received: March 19, 2010
Last updated: March 4, 2014
Last verified: March 2014
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
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:

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
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: 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


Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Genders Eligible for Study:   Both
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.
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Please refer to this study by its identifier: NCT01131559

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

Additional Information:
Responsible Party: Lindner Center of HOPE Identifier: NCT01131559     History of Changes
Other Study ID Numbers: Adjunctive LDX in BP 
Study First Received: March 19, 2010
Last Updated: March 4, 2014
Health Authority: United States: Institutional Review Board

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 processed this record on October 28, 2016