DepressionPhase 4NCT02228005
The Effect of a Selective Serotonin Reuptake Inhibitor on Gait, Balance, and Bone Metabolism in Older Adults
A Phase 4 study testing Sertraline in people with Depression, run by University Health Network, Toronto at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- Conditions the study is for
- Depression
- What is being tested?
- Sertraline
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteCanada
- Study dates
- Jul 2014to Jul 2016
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- Clinical diagnosis of Major Depression
- English-speaking
- If currently on an antidepressant, willing to undergo a 2 week washout.
- English-speaking
Who cannot join
- 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
Show all 11Show fewer
- Poor response or serious adverse event with sertraline in the past.
- Comparison group
- Lifetime diagnosis of depression or dementia
- Currently on antidepressant medication or mood stabilizer
- Poor baseline mobility or baseline severe gait disorder
Trial locations and contacts
1 site in 1 country.
Canada1 site
Toronto Rehabilitation Institute, University Health Network
Toronto, Ontario, M5G2A2
About this study
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.
Read the 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.
- Conditions
- Depression
- Being tested
- Sertraline
- Medical subject headings
- Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SertralineDrug
Also called Zoloft
Protocolized titration from 50 to max 200mg based on response and tolerance.
| Study group | Role | What they receive |
|---|---|---|
| Depression | Experimental | Sertraline 50- 200mg Receives: Drug: Sertraline |
| Comparison group (non-depressed) | No intervention | No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in number of steps to recover balance compared to baseline
Number of steps
Measured: Baseline, 3 weeks
Secondary outcomes (4)
Change in CTX-I (Serum collagen type-I cross-linked C-telopeptide)
pg/ml
Measured: 12 weeks
Change in P1NP (Serum procollagen type-1 N-terminal polypeptide)
ng/ml
Measured: 12 weeks
Change in stride variability from baseline
ms
Measured: Baseline, 3 weeks
Change in centre of pressure sway velocity under dual task conditions
cm/s
Measured: Baseline, 3 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2014 (estimated)
- Study startJul 2014
- Primary completionJul 2016
- Study completionJul 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DepressionStudies of the same condition, open and under way.
- More trials run by University Health Network, TorontoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Health Network, Toronto
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Andrea Iaboni, MD DPhil, Principal investigator, University Health Network and University of Toronto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02228005
- Sponsor's protocol ID
- DF-2013-10
- Status last verified
- Dec 2015
- First submitted
- 23 Jul 2014
- Last updated
- 4 May 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of a Selective Serotonin Reuptake Inhibitor on Gait, Balance, and Bone Metabolism in Older Adults
- ClinicalTrials.gov ID
- NCT02228005
- Acronym / sponsor ID
- DF-2013-10
- Conditions
- Depression
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- University Health Network, TorontoUniversity, hospital or other
- Study start
- Jul 2014
- Primary completion
- Jul 2016 (actual)
- Study completion
- Jul 2016 (actual)
- First posted
- 28 Aug 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Depression | Experimental | Drug: SertralineSertraline 50- 200mg |
| Comparison group (non-depressed) | No intervention | –No intervention |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (4 listed)
- Clinical diagnosis of Major Depression
- English-speaking
- If currently on an antidepressant, willing to undergo a 2 week washout.
- English-speaking
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SertralineAlso: ZoloftProtocolized titration from 50 to max 200mg based on response and tolerance. | Drug | Depression |
Primary outcome
Change in number of steps to recover balance compared to baseline
Time frame: Baseline, 3 weeks
Number of steps
4 secondary outcomes
Change in CTX-I (Serum collagen type-I cross-linked C-telopeptide)
Time frame: 12 weeks
Change in P1NP (Serum procollagen type-1 N-terminal polypeptide)
Time frame: 12 weeks
Change in stride variability from baseline
Time frame: Baseline, 3 weeks
Change in centre of pressure sway velocity under dual task conditions
Time frame: Baseline, 3 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 May 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Andrea Iaboni, MD DPhil principal investigator
University Health Network and University of Toronto
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Sertraline in people with Depression, run by University Health Network, Toronto at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 May 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in number of steps to recover balance compared to baseline (time frame: Baseline, 3 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 May 2017.