Adjunctive Lisdexamfetamine (LDX) in Bipolar Depression

NCT ID: NCT01131559

Last Updated: 2014-03-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE3

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-01-31

Study Completion Date

2014-02-28

Brief Summary

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The specific aim of this study is to evaluate the efficacy and tolerability of lisdexamfetamine in the adjunctive treatment of bipolar disorder.

Detailed Description

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Conditions

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Bipolar Depression

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Lisdexamfetamine

Drug

Group Type ACTIVE_COMPARATOR

Lisdexamfetamine

Intervention Type DRUG

Oral; 20-70mg/day

Placebo

Drug

Group Type PLACEBO_COMPARATOR

Placebo control

Intervention Type DRUG

Oral; 20-70mg/day

Interventions

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Lisdexamfetamine

Oral; 20-70mg/day

Intervention Type DRUG

Placebo control

Oral; 20-70mg/day

Intervention Type DRUG

Other Intervention Names

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Vyvanse Sugar pill, fake pill with no active medication

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* 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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Shire

INDUSTRY

Sponsor Role collaborator

University of Cincinnati

OTHER

Sponsor Role collaborator

Lindner Center of HOPE

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Lindner Center of HOPE

Mason, Ohio, United States

Site Status

Countries

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United States

Related Links

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http://lindnercenterofhope.org/research

Link to facility where study is conducted

Other Identifiers

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Adjunctive LDX in BP

Identifier Type: -

Identifier Source: org_study_id

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