Efficacy Study of Lisdexamfetamine to Treat Bipolar Depression

Bipolar Depression Clinical Trial

Official title:

Adjunctive Lisdexamfetamine in Bipolar Depression

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01093963
• Other study ID #: LDX BP
• Status: Terminated
• Phase: Phase 3
• First received: March 25, 2010
• Last updated: August 31, 2015
• Start date: January 2010
• Est. completion date: February 2014

Study information

• Verified date: August 2015
• Source: Lindner Center of HOPE
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 25
• Est. completion date: February 2014
• Est. primary completion date: February 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 55 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Bipolar Depression
• Bipolar Disorder
• Depression
• Depressive Disorder

Intervention

Drug:
• Lisdexamfetamine
oral; 20-70mg/day
• Placebo
oral; 20-70mg/day

Locations

Country	Name	City	State
United States	Lindner Center of HOP	Mason	Ohio

Sponsors (3)

Lead Sponsor	Collaborator
Lindner Center of HOPE	Shire, University of Cincinnati

Country where clinical trial is conducted

United States, 

References & Publications (1)

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.000000000000 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	30-36 months	Yes