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Ramelteon in the Treatment of Sleep and Mood in Patients With Seasonal Affective Disorder

NCT00502320 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2009-10-06

Study results available
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Summary

The purpose of this study is to determine whether treating sleep difficulties in patients with seasonal affective disorder also improves their depressive symptoms.

Conditions

  • Seasonal Affective Disorder

Interventions

DRUG

Ramelteon

one 8 mg tablet at bed for up to 4 months

DRUG

Placebo

one tablet at bedtime for up to 4 months

Sponsors & Collaborators

  • Takeda Pharmaceuticals North America, Inc.

    collaborator INDUSTRY

  • Lehigh Valley Hospital

    lead OTHER

Principal Investigators

  • Edward R. Norris, MD · Lehigh Valley Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2006-09-30
Primary Completion
2008-04-30
Completion
2008-07-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

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 NCT00502320 on ClinicalTrials.gov