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Targeting Circadian and Cognitive Dysfunction in Bipolar Disorder With Modafinil

NCT01965925 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 18

Last updated 2018-03-21

No results posted yet for this study

Summary

This is an 8-week, randomized, placebo-controlled trial of modafinil in stable bipolar disorder patients. Results will provide information on a promising treatment for simultaneously treating both sleep and cognitive problems in stable bipolar patients. These disabling symptoms persist despite stable mood and are strongly associated with functional disability, making them important treatment targets that have not yet been adequately addressed.

Conditions

Interventions

DRUG

Modafinil

Ratio of 2:1 subjects will be in the experimental arm receiving modafinil for 8 weeks.

DRUG

Placebo

For every randomly assigned 2 subjects receiving active drug, 1 will be randomly assigned to receive placebo for 8 weeks.

Sponsors & Collaborators

Principal Investigators

  • Katherine Burdick, PhD · Icahn School of Medicine at Mount Sinai

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-01-31
Primary Completion
2017-11-09
Completion
2017-11-09

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases
Companies

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 NCT01965925 on ClinicalTrials.gov