Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Prevention of Seasonal Affective Disorder

This study has been completed.
Sponsor:
Information provided by:
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00046449
First received: September 30, 2002
Last updated: July 26, 2010
Last verified: July 2010
  Purpose

A Placebo Controlled Study Evaluating The Effectivess Of Medication In Preventing Seasonal Affective Disorder


Condition Intervention Phase
Seasonal Affective Disorder (SAD)
Drug: Investigational Seasonal Affective Disorder (SAD) Drug
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria: (Patient must meet these criteria in order to be eligible for this study.)

  • Patient has a history of Major Depressive Disorder (MDD) with a seasonal pattern.

Exclusion Criteria: (Patient cannot meet these criteria in order to be eligible for this study.)

  • Patient has a current or past history of seizure disorder or brain injury.
  • Patient has a history or current diagnosis of anorexia nervousa or bulimia.
  • Patient has recurrent summer depression more frequently than winter depression.
  • Patient has primary diagnosis of panic disorder, Obsessive Compulsive Disorder (OCD), Posttraumatic Stress Disorder (PTSD), acute distress disorder, bipolar II disorder or other psychotic disorders.
  • Patient has initiated psychotherapy within the last 3 months.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00046449

  Show 54 Study Locations
Sponsors and Collaborators
GlaxoSmithKline
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00046449     History of Changes
Obsolete Identifiers: NCT00300144
Other Study ID Numbers: 398149
Study First Received: September 30, 2002
Last Updated: July 26, 2010
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Disease
Mood Disorders
Seasonal Affective Disorder
Depressive Disorder
Mental Disorders
Pathologic Processes

ClinicalTrials.gov processed this record on November 25, 2014