NCT01529905

Brief Summary

The goal of this project is to study the course and outcome of illness in individuals who present with a first episode of depression or mania, or who have a recurrent disorder but have never received treatment. We plan to examine psychological, physical, social and environmental factors that may affect long-term outcome in these disorders

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 1999

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 1999

Completed
10.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2009

Completed
2.4 years until next milestone

First Submitted

Initial submission to the registry

February 7, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 9, 2012

Completed
2.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2014

Completed
Last Updated

February 9, 2012

Status Verified

June 1, 2005

Enrollment Period

10.3 years

First QC Date

February 7, 2012

Last Update Submit

February 8, 2012

Conditions

Keywords

depressionmaniabipolaroutcomecognitive

Eligibility Criteria

Age16 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodProbability Sample
Study Population

patients who present to a tertiary care clinic for first treatment of depression or mania

You may qualify if:

  • Primary Mood Disorder,
  • Age 16-50
  • No previous treatment with psychotropic medication (may have had a max. of 5 days treatment with antidepressants/mood stabilizer \&/or they may have Haldol \&/or Lorazepam for clear restraint)

You may not qualify if:

  • History of CNS illness (except migraines),
  • Thyroid Disease,
  • Neoplastic illness
  • History of, or currently being treated for, Anorexia or Bulimia
  • History of Traumatic Brain Injury
  • Current treatment of Attention-Deficit Hyperactivity Disorder (ADHD)
  • Previous diagnosis of OCD or primary Anxiety disorder
  • Axis-II diagnosis that would suggest non-responsiveness to pharmacotherapy.
  • Substance dependence

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

St. Joseph's Healthcare, Centre for Mountain Health Services

Hamilton, Ontario, L8N 3K7, Canada

RECRUITING

Related Publications (3)

  • Judd LL, Akiskal HS, Maser JD, Zeller PJ, Endicott J, Coryell W, Paulus MP, Kunovac JL, Leon AC, Mueller TI, Rice JA, Keller MB. A prospective 12-year study of subsyndromal and syndromal depressive symptoms in unipolar major depressive disorders. Arch Gen Psychiatry. 1998 Aug;55(8):694-700. doi: 10.1001/archpsyc.55.8.694.

    PMID: 9707379BACKGROUND
  • Solomon DA, Keller MB, Leon AC, Mueller TI, Shea MT, Warshaw M, Maser JD, Coryell W, Endicott J. Recovery from major depression. A 10-year prospective follow-up across multiple episodes. Arch Gen Psychiatry. 1997 Nov;54(11):1001-6. doi: 10.1001/archpsyc.1997.01830230033005.

    PMID: 9366656BACKGROUND
  • Mueller TI, Keller MB, Leon AC, Solomon DA, Shea MT, Coryell W, Endicott J. Recovery after 5 years of unremitting major depressive disorder. Arch Gen Psychiatry. 1996 Sep;53(9):794-9. doi: 10.1001/archpsyc.1996.01830090040006.

    PMID: 8792756BACKGROUND

MeSH Terms

Conditions

Depressive Disorder, MajorBipolar DisorderDepressionMania

Condition Hierarchy (Ancestors)

Depressive DisorderMood DisordersMental DisordersBipolar and Related DisordersBehavioral SymptomsBehaviorNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Glenda MacQueen, MD, PhD

    McMaster University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Helen Begin, RN

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 7, 2012

First Posted

February 9, 2012

Study Start

June 1, 1999

Primary Completion

September 1, 2009

Study Completion

June 1, 2014

Last Updated

February 9, 2012

Record last verified: 2005-06

Locations