The Effect of a Selective Serotonin Reuptake Inhibitor on Gait, Balance, and Bone Metabolism in Older Adults
1 other identifier
interventional
25
1 country
1
Brief Summary
The purpose of this study is to examine the effects of sertraline treatment of depression in older adults on gait stability, balance recovery reactions, and markers of bone metabolism. This is a pilot study that will determine feasibility and generate hypotheses for a larger definitive study.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_4 depression
Started Jul 2014
1 active site
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
July 1, 2014
CompletedFirst Submitted
Initial submission to the registry
July 23, 2014
CompletedFirst Posted
Study publicly available on registry
August 28, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2016
CompletedMay 4, 2017
December 1, 2015
2 years
July 23, 2014
May 3, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
Change in number of steps to recover balance compared to baseline
Number of steps
Baseline, 3 weeks
Secondary Outcomes (4)
Change in CTX-I (Serum collagen type-I cross-linked C-telopeptide)
12 weeks
Change in P1NP (Serum procollagen type-1 N-terminal polypeptide)
12 weeks
Change in stride variability from baseline
Baseline, 3 weeks
Change in centre of pressure sway velocity under dual task conditions
Baseline, 3 weeks
Study Arms (2)
Depression
EXPERIMENTALSertraline 50- 200mg
Comparison group (non-depressed)
NO INTERVENTIONNo intervention
Interventions
Protocolized titration from 50 to max 200mg based on response and tolerance.
Eligibility Criteria
You may qualify if:
- Clinical diagnosis of Major Depression
- English-speaking
- If currently on an antidepressant, willing to undergo a 2 week washout.
You may not qualify if:
- Lifetime bipolar disorder
- Current psychotic disorder or substance use disorder
- Dementia
- Poor baseline mobility or baseline severe gait disorder
- On treatment with fluoxetine or mood stabilizer
- Severe renal impairment, bleeding disorder, recent gastric bleeding or hemorrhagic stroke in past 3 months
- Poor response or serious adverse event with sertraline in the past.
- Comparison group
- \- English-speaking
- Lifetime diagnosis of depression or dementia
- Currently on antidepressant medication or mood stabilizer
- Poor baseline mobility or baseline severe gait disorder
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Toronto Rehabilitation Institute, University Health Network
Toronto, Ontario, M5G2A2, Canada
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Andrea Iaboni, MD DPhil
University Health Network and University of Toronto
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 23, 2014
First Posted
August 28, 2014
Study Start
July 1, 2014
Primary Completion
July 1, 2016
Study Completion
July 1, 2016
Last Updated
May 4, 2017
Record last verified: 2015-12