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Efficacy Study of Lisdexamfetamine to Treat Bipolar Depression

Primary Purpose

Bipolar Depression

Status
Terminated
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Lisdexamfetamine
Placebo
Sponsored by
Lindner Center of HOPE
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Bipolar Depression

Eligibility Criteria

18 Years - 55 Years (Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Lindner Center of HOP

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Lisdexamfetamine

Placebo

Arm Description

Drug

Drug

Outcomes

Primary Outcome Measures

Change in the Montgomery-Asberg Depression Rating Scale
Efficacy will be assessed by measuring the baseline-to-endpoint change in the Montgomery-Asberg Depression Rating Scale (MADRS)

Secondary Outcome Measures

Full Information

First Posted
March 25, 2010
Last Updated
August 31, 2015
Sponsor
Lindner Center of HOPE
Collaborators
Shire, University of Cincinnati
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1. Study Identification

Unique Protocol Identification Number
NCT01093963
Brief Title
Efficacy Study of Lisdexamfetamine to Treat Bipolar Depression
Official Title
Adjunctive Lisdexamfetamine in Bipolar Depression
Study Type
Interventional

2. Study Status

Record Verification Date
August 2015
Overall Recruitment Status
Terminated
Why Stopped
Enrollment goals not met
Study Start Date
January 2010 (undefined)
Primary Completion Date
February 2014 (Actual)
Study Completion Date
February 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Lindner Center of HOPE
Collaborators
Shire, University of Cincinnati

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bipolar Depression

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
25 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Lisdexamfetamine
Arm Type
Active Comparator
Arm Description
Drug
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Drug
Intervention Type
Drug
Intervention Name(s)
Lisdexamfetamine
Intervention Description
oral; 20-70mg/day
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
oral; 20-70mg/day
Primary Outcome Measure Information:
Title
Change in the Montgomery-Asberg Depression Rating Scale
Description
Efficacy will be assessed by measuring the baseline-to-endpoint change in the Montgomery-Asberg Depression Rating Scale (MADRS)
Time Frame
30-36 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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.
Facility Information:
Facility Name
Lindner Center of HOP
City
Mason
State/Province
Ohio
ZIP/Postal Code
45040
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
25340384
Citation
McElroy SL, Martens BE, Mori N, Blom TJ, Casuto LS, Hawkins JM, Keck PE Jr. Adjunctive lisdexamfetamine in bipolar depression: a preliminary randomized, placebo-controlled trial. Int Clin Psychopharmacol. 2015 Jan;30(1):6-13. doi: 10.1097/YIC.0000000000000051.
Results Reference
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Efficacy Study of Lisdexamfetamine to Treat Bipolar Depression

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