Efficacy Study of Lisdexamfetamine to Treat Bipolar Depression

This study has been terminated.
(Enrollment goals not met)
Sponsor:
Collaborators:
Shire
University of Cincinnati
Information provided by (Responsible Party):
Lindner Center of HOPE
ClinicalTrials.gov Identifier:
NCT01093963
First received: March 25, 2010
Last updated: March 28, 2014
Last verified: March 2014
  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
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 the Montgomery-Asberg Depression Rating Scale [ Time Frame: 30-36 months ] [ Designated as safety issue: Yes ]
    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

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Lindner Center of HOPE
ClinicalTrials.gov Identifier: NCT01093963     History of Changes
Other Study ID Numbers: LDX BP
Study First Received: March 25, 2010
Last Updated: March 28, 2014
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on August 28, 2014