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The Effect of a Selective Serotonin Reuptake Inhibitor on Gait, Balance, and Bone Metabolism in Older Adults

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ClinicalTrials.gov Identifier: NCT02228005
Recruitment Status : Completed
First Posted : August 28, 2014
Last Update Posted : May 4, 2017
Sponsor:
Information provided by (Responsible Party):
University Health Network, Toronto

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.

Condition or disease Intervention/treatment Phase
Depression Drug: Sertraline Phase 4

Detailed Description:

Selective serotonin reuptake inhibitors (SSRIs) are a class of antidepressant medication frequently used to treat depressive and anxiety disorders in the elderly. Although widely considered to be a safe option, several observational studies have found that SSRIs have as strong an association with falls as other psychotropic medications including tricyclic antidepressants and benzodiazepines. However, the potential mechanism for a link between SSRIs and falls is unclear. Compared to other psychotropic medications, SSRIs have lower rates of side effects that could contribute to falls, including sedation, orthostatic blood pressure changes, and anticholinergicity. Interestingly, SSRIs have also been associated with fractures, more so than other classes of antidepressants, in both administrative database studies and prospective cohort studies that control for falls history. Serotonin is known to play a role in regulating bone mass and some studies have found a loss of bone mass in individuals on SSRI treatment.

The association of SSRIs with falls and fractures is confounded by depression which is itself associated with falls, gait instability, bone loss and fractures. The goal of this study is to disentangle the contribution of the disease versus the treatment to risk of falls and fractures. As a first step towards this goal, this pilot study will: i) estimate effect sizes for statistical power calculations for an adequately powered study; and ii) examine the feasibility of timely recruitment of older patients with major depression who have not taken antidepressant medication for a minimum of 2 weeks prior to entering the study.

To address our research question, we have designed a prospective observational pilot study. Older adults with depression will be assessed at baseline, and then 3,6, and 12 weeks after initiation of sertraline antidepressant therapy. A non-depressed comparison group will be used to control for the learning effects of repeated assessment. The outcomes of interest are changes in gait, static balance, and dynamic balance recovery reactions. Our primary outcomes are the short-term changes in these variables at 3 weeks, but we will also perform a longitudinal analysis to assess change over 12 weeks.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 25 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Effect of a Selective Serotonin Reuptake Inhibitor on Gait, Balance, and Bone Metabolism in Older Adults
Study Start Date : July 2014
Actual Primary Completion Date : July 2016
Actual Study Completion Date : July 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Depression
Sertraline 50- 200mg
Drug: Sertraline
Protocolized titration from 50 to max 200mg based on response and tolerance.
Other Name: Zoloft

No Intervention: Comparison group (non-depressed)
No intervention



Primary Outcome Measures :
  1. Change in number of steps to recover balance compared to baseline [ Time Frame: Baseline, 3 weeks ]
    Number of steps


Secondary Outcome Measures :
  1. Change in CTX-I (Serum collagen type-I cross-linked C-telopeptide) [ Time Frame: 12 weeks ]
    pg/ml

  2. Change in P1NP (Serum procollagen type-1 N-terminal polypeptide) [ Time Frame: 12 weeks ]
    ng/ml

  3. Change in stride variability from baseline [ Time Frame: Baseline, 3 weeks ]
    ms

  4. Change in centre of pressure sway velocity under dual task conditions [ Time Frame: Baseline, 3 weeks ]
    cm/s



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Ages Eligible for Study:   65 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Depressed group

Inclusion Criteria:

  • Clinical diagnosis of Major Depression
  • English-speaking
  • If currently on an antidepressant, willing to undergo a 2 week washout.

Exclusion Criteria:

  • 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

Inclusion Criteria:

- English-speaking

Exclusion Criteria:

  • Lifetime diagnosis of depression or dementia
  • Currently on antidepressant medication or mood stabilizer
  • Poor baseline mobility or baseline severe gait disorder

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02228005


Locations
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Canada, Ontario
Toronto Rehabilitation Institute, University Health Network
Toronto, Ontario, Canada, M5G2A2
Sponsors and Collaborators
University Health Network, Toronto
Investigators
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Principal Investigator: Andrea Iaboni, MD DPhil University Health Network and University of Toronto

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Responsible Party: University Health Network, Toronto
ClinicalTrials.gov Identifier: NCT02228005     History of Changes
Other Study ID Numbers: DF-2013-10
First Posted: August 28, 2014    Key Record Dates
Last Update Posted: May 4, 2017
Last Verified: December 2015
Additional relevant MeSH terms:
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Depression
Behavioral Symptoms
Sertraline
Serotonin Uptake Inhibitors
Serotonin
Antidepressive Agents
Psychotropic Drugs
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Serotonin Agents
Physiological Effects of Drugs
Serotonin Receptor Agonists