NCT01477268

Brief Summary

Major depression is a very common health problem affecting older persons. The present standard of treatment is with medications called "antidepressants". Antidepressants have been studied extensively in older persons with normal brain function and have been shown to be effective. However, certain types of brain dysfunction called "executive impairment" (inability to do higher order thinking) may lead to poor treatment outcomes. This study will compare how older depressed people with different levels of executive impairment respond differently to standard antidepressant treatment. Knowing this information will lead to more rational targeting of available treatments, leading to improved treatment outcomes.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at P25-P50 for phase_4 depression

Timeline
Completed

Started Jun 2007

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2007

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2009

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

June 9, 2009

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2009

Completed
2.1 years until next milestone

First Posted

Study publicly available on registry

November 22, 2011

Completed
Last Updated

November 22, 2011

Status Verified

May 1, 2011

Enrollment Period

1.8 years

First QC Date

June 9, 2009

Last Update Submit

November 18, 2011

Conditions

Depression

Keywords

antidepressantsdepressionzoloftpsychiatrypsychology

Outcome Measures

Primary Outcomes (1)

  • depression

    June 1, 2007 - June 1, 2008

Study Arms (1)

zoloft

OTHER

Both arms of the study will include zoloft. However, the treatment response to zoloft will be compared in two different subgroups.

Drug: Zoloft (antidepressant)

Interventions

Zoloft (antidepressant)DRUG

Zoloft 50-200 mg po od x 12 weeks

Also known as: Sertraline
zoloft

Eligibility Criteria

Age65 Years - 90 Years
Sexall
Healthy VolunteersYes
Age GroupsOlder Adult (65+)

You may qualify if:

  • above the age of 65,
  • speak English fluently,
  • experience depression, AND
  • not yet on active treatment.

You may not qualify if:

  • active delirium,
  • substance abuse,
  • mental illness other than major depression,
  • active CNS disease,
  • unstable systematic medical disease, OR
  • current of past psychotic disorder.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

St Michael's Hospital

Toronto, Ontario, M5B 1W8, Canada

Location

MeSH Terms

Conditions

Depression

Interventions

SertralineAntidepressive Agents

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehavior

Intervention Hierarchy (Ancestors)

1-NaphthylamineAminesOrganic ChemicalsNaphthalenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsPolycyclic CompoundsPsychotropic DrugsCentral Nervous System AgentsTherapeutic UsesPharmacologic ActionsChemical Actions and Uses

Study Officials

  • Corinne Fischer, MD

    St. Michaels Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

June 9, 2009

First Posted

November 22, 2011

Study Start

June 1, 2007

Primary Completion

April 1, 2009

Study Completion

October 1, 2009

Last Updated

November 22, 2011

Record last verified: 2011-05

Locations

CA(1)