NCT01131559

Brief Summary

The specific aim of this study is to evaluate the efficacy and tolerability of 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
50

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 19, 2010

Completed
2 months until next milestone

First Posted

Study publicly available on registry

May 27, 2010

Completed
3.7 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

March 5, 2014

Status Verified

March 1, 2014

Enrollment Period

4.1 years

First QC Date

March 19, 2010

Last Update Submit

March 4, 2014

Conditions

BipolarDepression

Keywords

bipolar disordermanic depressiondepressionBipolar I or II

Outcome Measures

Primary Outcomes (1)

  • Change in MADRS score

    The primary efficacy variable is baseline-to-endpoint change in Montgomery-Asberg Depression Rating Scale (MADRS) score.

    30-36 months

Study Arms (2)

Lisdexamfetamine

ACTIVE COMPARATOR

Drug

Drug: Lisdexamfetamine

Placebo

PLACEBO COMPARATOR

Drug

Drug: Placebo control

Interventions

LisdexamfetamineDRUG

Oral; 20-70mg/day

Also known as: Vyvanse
Lisdexamfetamine
Placebo controlDRUG

Oral; 20-70mg/day

Also known as: Sugar pill, fake pill with no active medication
Placebo

Eligibility Criteria

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

You may qualify if:

  • Subjects will meet DSM-IV-TR criteria bipolar I or II disorder,

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Lindner Center of HOPE

Mason, Ohio, 45040, United States

Location

Related Links

MeSH Terms

Conditions

DepressionBipolar Disorder

Interventions

Lisdexamfetamine Dimesylate

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehaviorBipolar 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 19, 2010

First Posted

May 27, 2010

Study Start

January 1, 2010

Primary Completion

February 1, 2014

Study Completion

February 1, 2014

Last Updated

March 5, 2014

Record last verified: 2014-03

Locations

US(1)