NCT01093963

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
25

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Jan 2010

Typical duration for phase_3

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2010

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

March 25, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 26, 2010

Completed
3.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2014

Completed
Last Updated

September 2, 2015

Status Verified

August 1, 2015

Enrollment Period

4.1 years

First QC Date

March 25, 2010

Last Update Submit

August 31, 2015

Conditions

Bipolar Depression

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (2)

Lisdexamfetamine

ACTIVE COMPARATOR

Drug

Drug: Lisdexamfetamine

Placebo

PLACEBO COMPARATOR

Drug

Drug: Placebo

Interventions

LisdexamfetamineDRUG

oral; 20-70mg/day

Lisdexamfetamine
PlaceboDRUG

oral; 20-70mg/day

Placebo

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Lindner Center of HOP

Mason, Ohio, 45040, United States

Location

Related 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.0000000000000051.

    PMID: 25340384RESULT

MeSH Terms

Conditions

Bipolar Disorder

Interventions

Lisdexamfetamine Dimesylate

Condition Hierarchy (Ancestors)

Bipolar and Related DisordersMood DisordersMental Disorders

Intervention Hierarchy (Ancestors)

DextroamphetamineAmphetamineAmphetaminesPhenethylaminesEthylaminesAminesOrganic Chemicals

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 25, 2010

First Posted

March 26, 2010

Study Start

January 1, 2010

Primary Completion

February 1, 2014

Study Completion

February 1, 2014

Last Updated

September 2, 2015

Record last verified: 2015-08

Locations

US(1)