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Efficacy Study of Lisdexamfetamine to Treat Bipolar Depression

NCT01093963 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 25

Last updated 2015-09-02

No results posted yet for this study

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.

Conditions

Interventions

DRUG

Lisdexamfetamine

oral; 20-70mg/day

DRUG

Placebo

oral; 20-70mg/day

Sponsors & Collaborators

  • Shire

    collaborator INDUSTRY

  • University of Cincinnati

    collaborator OTHER

  • Lindner Center of HOPE

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2010-01-31
Primary Completion
2014-02-28
Completion
2014-02-28

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01093963 on ClinicalTrials.gov