DepressionNCT02804347
The Effects of ECT and/or iTBS on Olfaction and Cognition in Patients With Depression
An observational study of Depression, run by Queen's University.
Trial summary
The sense of smell and cognition are known to be closely associated with mood and emotional processes. However, despite the clear links between olfaction and cognitive processes with emotional states, research into the role of olfaction, cognition, and mood disorders has so far yielded variable results. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Depression
- What is being tested?
- Cognitive Function Imaging and Battery, Sniffin Sticks and Cognitive Batteries
- Type of treatment
- Medical device
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- Mar 2016to Jul 2017
- Phase
- Observational
- 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 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: The study population will consist of patients receiving iTBS or ECT at Providence Continuing Care Mental Health Services Site and healthy controls recruited from the Kingston Area. Patients may originate from a number of locations and clinics in the area but receive their treatment at Providence Care and have been referred to this location for such. Controls should be age and gender matched to participants and will be recruited from the Kingston region.
Who may be able to join
- Signed Patient Informed Consent
- Patients with MDD (DSM-IV-TR - criteria used) OR Patients with bipolar depression (DSM-IV-TR - criteria used)
- Males or females over 18 years of age
- In-patients or out-patients currently scheduled to receive ECT or rTMS
Who cannot join
- Patients suffering from other neurological or endocrine disorders known to affect olfactory functioning.
- Patients suffering from a respiratory tract infection or other respiratory disorder known to affect olfactory functioning at investigator's discretion
- Schizophrenia, Schizoaffective or other Psychotic Disorder
- Patients over 65 years of age
- Patients with significant allergies
- Patients with environmental sensitivities (e.g. perfumes)
- Patients with mechanical obstruction of the nasal passages (e.g. deviated septum)
- Patients with congenital anosmia or other previous primary olfactory dysfunction
About this study
Official title: The Effects of Electroconvulsive Therapy (ECT) and/or Intermittent Theta Burst Stimulation (iTBS) on Olfaction and Cognition in Patients With Depression
The sense of smell and cognition are known to be closely associated with mood and emotional processes. However, despite the clear links between olfaction and cognitive processes with emotional states, research into the role of olfaction, cognition, and mood disorders has so far yielded variable results. This study proposes to investigate the ability to detect and identify odours and assess cognition in a group of patients with unipolar and bipolar depression prior to and after receiving their scheduled electroconvulsive therapy (ECT) or intermittent theta burst stimulation (iTBS) treatments. Olfaction will be evaluated utilizing standard olfactory testing protocols using commercially available kits. Cognition will be evaluated utilizing standard cognitive test protocols in a functional magnetic resonance imaging protocol. The results will potentially shed light on the link between olfaction, cognition and mood disorders.
Read the detailed description
The research to date indicates that olfactory sensitivity and cognition are reduced in depressed patients. The data also suggest that higher order cognitive odour evaluation, measured via identification testing, is not altered in depression. Furthermore, research into the effect (if any) of treatment on olfactory performance (sensitivity and identification) has been sparse. Researchers have called for studies that examine olfactory sensitivity prior to psychiatric treatment and post-remission. To the best of our knowledge there has yet to be a study on the effect of electroconvulsive therapy (ECT) or intermittent theta burst stimulation (iTBS) treatments on the olfactory performance of patients with treatment refractory Major Depressive Disorder (MDD) and bipolar depression. ECT has been identified as today's most effective treatment for severe depression due to the remission rates, speed of response, and the completeness of remission. iTBS is a new remittent transcranial magnetic stimulation (rTMS) protocol that has gained more notoriety within the field for the speed of administration, effectiveness of the treatment, and speed of response. Unlike rTMS, TBS mimics the endogenous theta rhythms of the brain, which results in greater potency in inducing long-term potentiation of synaptic connections in the targeted brain regions. iTBS has been shown to be effective in treating mood disturbances, and increasing plasticity and inducing neurogenesis in patients. People with MDD often struggle with cognitive impairments such as decreased executive functioning, attention, concentration, speed of processing, and working memory. The brain areas associated with cognition, such as the prefrontal cortex and hippocampus are negatively affected by depression; studies have shown decreased volume, activity, and disturbed brain connectivity in those two areas. Currently, there is a lack of treatment options for improving cognition in depressed patients. The investigators are focussing on exploring the therapeutic potential of iTBS on cognition.The preliminary evidence from our study will add to scientists' understanding of the short and long term effects of iTBS treatment on the cognitive related areas in the brain through the use of fMRI. The investigators also hope our research will allow psychiatrists to deliver better care to patients with debilitating cognitive impairments associated with depression. Overall, a study examining the olfactory and cognitive performance of patients with treatment resistant MDD and bipolar depression, pre-ECT/iTBS, post-ECT/iTBS, and post-remission would yield valuable insight into the link between olfaction and mood disorders as well as cognition and mood disorders.
- Conditions
- Depression
- Being tested
- Cognitive Function Imaging and Battery, Sniffin Sticks, Cognitive Batteries
- Keywords
- Olfactory Dysfunction, Electroconvulsive Therapy, Theta Burst Stimulation
- Medical subject headings
- Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive Function Imaging and BatteryDevice
Individuals will be placed in the fMRI scanner and complete the NBACK Cognitive Task
Sniffin SticksDevice
Using Sniffin Sticks, olfactory functioning will be assessed using three tests: identification, discrimination, and threshold.
Cognitive BatteriesOther
Participants will conduct the following cognitive batteries: DSST, TMT A \& B, RAVLT
| Study group | Role | What they receive |
|---|---|---|
| Patient | Patients will be receiving either ECT or iTBS as a depression management. Olfactory functioning will be assessed at pre-treatment and 6 weeks later at post-treatment using Sniffin Sticks. Cognition will also be tested using Cognitive Function Imaging and Battery in the fMRI as well as Cognitive Batteries outside of the scanner at pre-treatment, 6 weeks later at post-treatment, and 3 months after the final treatment session. Receives: Device: Cognitive Function Imaging and Battery; Device: Sniffin Sticks; Other: Cognitive Batteries | |
| Control | Controls will have their olfactory functioning assessed at baseline and 6 weeks after the baseline assessment using Sniffin Sticks. Cognition will also be tested using Cognitive Function Imaging and Battery in the fMRI as well as Cognitive Batteries outside of the scanner at pre-treatment, 6 weeks later at post-treatment, and 3 months after the final treatment session. Receives: Device: Cognitive Function Imaging and Battery; Device: Sniffin Sticks; Other: Cognitive Batteries |
What is being measured
The primary outcome is the main question the study is designed to answer.
Olfactory Function Change using Burghart's Sniffin' Sticks
Measured: Baseline and 6 weeks
Cognitive Function Change using NBACK, Shopping List, and Symbol Span Tests
Measured: Baseline, 6 weeks, 3 months
Secondary outcomes (3)
Participant's Olfactory Identification using Sniffin' Sticks Identification Test
Measured: Baseline and 6 weeks
Participant's Olfactory Threshold using Sniffin' Sticks Threshold Test
Measured: Baseline and 6 weeks
Participant's Olfactory Discrimination using Sniffin' Sticks DiscriminationTest
Measured: Baseline and 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2016 (estimated)
- Study startMar 2016
- Primary completionJul 2017
- Study completionJul 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (33)Papers the sponsor has linked to this study.
- Other trials for DepressionStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Queen's University
- Sponsor type
- University, hospital or other
- Collaborators
- Providence Healthcare
- Responsible party
- Principal investigator, Dr. Roumen Milev, Queen's University
- Investigators
- Roumen V Milev, MD FRCPC, Principal investigator, Queen's University Department of Psychiatry
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02804347
- Sponsor's protocol ID
- 6006093
- Status last verified
- Sep 2017
- First submitted
- 2 Jun 2016
- Last updated
- 6 Sep 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Publications
Ludvigson, H.W., & Rottman, T.R. (1989). Effects of ambient odours of lavender and cloves on cognition, memory, affect, and mood. Chemical Senses, 14(4), 525-536.
Albrecht J, Wiesmann M. [The human olfactory system. Anatomy and physiology]. Nervenarzt. 2006 Aug;77(8):931-9. doi: 10.1007/s00115-006-2121-z. German.
PubMed 16871378Amsterdam JD, Settle RG, Doty RL, Abelman E, Winokur A. Taste and smell perception in depression. Biol Psychiatry. 1987 Dec;22(12):1481-5. doi: 10.1016/0006-3223(87)90108-9. No abstract available.
PubMed 3676376Austin MP, Mitchell P, Goodwin GM. Cognitive deficits in depression: possible implications for functional neuropathology. Br J Psychiatry. 2001 Mar;178:200-6. doi: 10.1192/bjp.178.3.200.
PubMed 11230029Berendse HW, Ponsen MM. Detection of preclinical Parkinson's disease along the olfactory trac(t). J Neural Transm Suppl. 2006;(70):321-5. doi: 10.1007/978-3-211-45295-0_48.
PubMed 17017547Brand G, Millot JL, Henquell D. Complexity of olfactory lateralization processes revealed by functional imaging: a review. Neurosci Biobehav Rev. 2001 Mar;25(2):159-66. doi: 10.1016/s0149-7634(01)00005-7.
PubMed 11323080Castaneda AE, Tuulio-Henriksson A, Marttunen M, Suvisaari J, Lonnqvist J. A review on cognitive impairments in depressive and anxiety disorders with a focus on young adults. J Affect Disord. 2008 Feb;106(1-2):1-27. doi: 10.1016/j.jad.2007.06.006. Epub 2007 Aug 20.
PubMed 17707915Doty RL, Shaman P, Dann M. Development of the University of Pennsylvania Smell Identification Test: a standardized microencapsulated test of olfactory function. Physiol Behav. 1984 Mar;32(3):489-502. doi: 10.1016/0031-9384(84)90269-5.
PubMed 6463130Drevets WC. Functional anatomical abnormalities in limbic and prefrontal cortical structures in major depression. Prog Brain Res. 2000;126:413-31. doi: 10.1016/S0079-6123(00)26027-5.
PubMed 11105660Frodl T, Meisenzahl EM, Zetzsche T, Born C, Groll C, Jager M, Leinsinger G, Bottlender R, Hahn K, Moller HJ. Hippocampal changes in patients with a first episode of major depression. Am J Psychiatry. 2002 Jul;159(7):1112-8. doi: 10.1176/appi.ajp.159.7.1112.
PubMed 12091188Fung PK, Robinson PA. Neural field theory of synaptic metaplasticity with applications to theta burst stimulation. J Theor Biol. 2014 Jan 7;340:164-76. doi: 10.1016/j.jtbi.2013.09.021. Epub 2013 Sep 21.
PubMed 24060620Gentner R, Wankerl K, Reinsberger C, Zeller D, Classen J. Depression of human corticospinal excitability induced by magnetic theta-burst stimulation: evidence of rapid polarity-reversing metaplasticity. Cereb Cortex. 2008 Sep;18(9):2046-53. doi: 10.1093/cercor/bhm239. Epub 2007 Dec 28.
PubMed 18165282Golinkoff M, Sweeney JA. Cognitive impairments in depression. J Affect Disord. 1989 Sep-Oct;17(2):105-12. doi: 10.1016/0165-0327(89)90032-3.
PubMed 2527885Gross-Isseroff R, Luca-Haimovici K, Sasson Y, Kindler S, Kotler M, Zohar J. Olfactory sensitivity in major depressive disorder and obsessive compulsive disorder. Biol Psychiatry. 1994 May 15;35(10):798-802. doi: 10.1016/0006-3223(94)91142-8.
PubMed 8043710Hawkes C. Olfaction in neurodegenerative disorder. Mov Disord. 2003 Apr;18(4):364-72. doi: 10.1002/mds.10379.
PubMed 12671941
Study at a glance
From the registry record, last updated by the sponsor on 6 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Electroconvulsive Therapy (ECT) and/or Intermittent Theta Burst Stimulation (iTBS) on Olfaction and Cognition in Patients With Depression
- ClinicalTrials.gov ID
- NCT02804347
- Acronym / sponsor ID
- 6006093
- Conditions
- Depression
- Keywords
- Olfactory Dysfunction, Electroconvulsive Therapy, Theta Burst Stimulation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Queen's UniversityUniversity, hospital or other
- Collaborators
- Providence Healthcare
- Study start
- Mar 2016
- Primary completion
- Jul 2017 (actual)
- Study completion
- Jul 2017 (actual)
- First posted
- 17 Jun 2016 (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 sense of smell and cognition are known to be closely associated with mood and emotional processes. However, despite the clear links between olfaction and cognitive processes with emotional states, research into the role of olfaction, cognition, and mood disorders has so far yielded variable results. This study proposes to investigate the ability to detect and identify odours and assess cognition in a group of patients with unipolar and bipolar depression prior to and after receiving their scheduled electroconvulsive therapy (ECT) or intermittent theta burst stimulation (iTBS) treatments. Olfaction will be evaluated utilizing standard olfactory testing protocols using commercially available kits. Cognition will be evaluated utilizing standard cognitive test protocols in a functional magnetic resonance imaging protocol. The results will potentially shed light on the link between olfaction, cognition and mood disorders.
Detailed description
The research to date indicates that olfactory sensitivity and cognition are reduced in depressed patients. The data also suggest that higher order cognitive odour evaluation, measured via identification testing, is not altered in depression. Furthermore, research into the effect (if any) of treatment on olfactory performance (sensitivity and identification) has been sparse. Researchers have called for studies that examine olfactory sensitivity prior to psychiatric treatment and post-remission. To the best of our knowledge there has yet to be a study on the effect of electroconvulsive therapy (ECT) or intermittent theta burst stimulation (iTBS) treatments on the olfactory performance of patients with treatment refractory Major Depressive Disorder (MDD) and bipolar depression. ECT has been identified as today's most effective treatment for severe depression due to the remission rates, speed of response, and the completeness of remission. iTBS is a new remittent transcranial magnetic stimulation (rTMS) protocol that has gained more notoriety within the field for the speed of administration, effectiveness of the treatment, and speed of response. Unlike rTMS, TBS mimics the endogenous theta rhythms of the brain, which results in greater potency in inducing long-term potentiation of synaptic connections in the targeted brain regions. iTBS has been shown to be effective in treating mood disturbances, and increasing plasticity and inducing neurogenesis in patients. People with MDD often struggle with cognitive impairments such as decreased executive functioning, attention, concentration, speed of processing, and working memory. The brain areas associated with cognition, such as the prefrontal cortex and hippocampus are negatively affected by depression; studies have shown decreased volume, activity, and disturbed brain connectivity in those two areas. Currently, there is a lack of treatment options for improving cognition in depressed patients. The investigators are focussing on exploring the therapeutic potential of iTBS on cognition.The preliminary evidence from our study will add to scientists' understanding of the short and long term effects of iTBS treatment on the cognitive related areas in the brain through the use of fMRI. The investigators also hope our research will allow psychiatrists to deliver better care to patients with debilitating cognitive impairments associated with depression. Overall, a study examining the olfactory and cognitive performance of patients with treatment resistant MDD and bipolar depression, pre-ECT/iTBS, post-ECT/iTBS, and post-remission would yield valuable insight into the link between olfaction and mood disorders as well as cognition and mood disorders.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patient | – | Device: Cognitive Function Imaging and Battery, Device: Sniffin Sticks, Other: Cognitive BatteriesPatients will be receiving either ECT or iTBS as a depression management. Olfactory functioning will be assessed at pre-treatment and 6 weeks later at post-treatment using Sniffin Sticks. Cognition will also be tested using Cognitive Function Imaging and Battery in the fMRI as well as Cognitive Batteries outside of the scanner at pre-treatment, 6 weeks later at post-treatment, and 3 months after the final treatment session. |
| Control | – | Device: Cognitive Function Imaging and Battery, Device: Sniffin Sticks, Other: Cognitive BatteriesControls will have their olfactory functioning assessed at baseline and 6 weeks after the baseline assessment using Sniffin Sticks. Cognition will also be tested using Cognitive Function Imaging and Battery in the fMRI as well as Cognitive Batteries outside of the scanner at pre-treatment, 6 weeks later at post-treatment, and 3 months after the final treatment session. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The study population will consist of patients receiving iTBS or ECT at Providence Continuing Care Mental Health Services Site and healthy controls recruited from the Kingston Area. Patients may originate from a number of locations and clinics in the area but receive their treatment at Providence Care and have been referred to this location for such. Controls should be age and gender matched to participants and will be recruited from the Kingston region.
Key inclusion criteria (4 listed)
- Signed Patient Informed Consent
- Patients with MDD (DSM-IV-TR - criteria used) OR Patients with bipolar depression (DSM-IV-TR - criteria used)
- Males or females over 18 years of age
- In-patients or out-patients currently scheduled to receive ECT or rTMS
Key exclusion criteria (8 listed)
- Patients suffering from other neurological or endocrine disorders known to affect olfactory functioning.
- Patients suffering from a respiratory tract infection or other respiratory disorder known to affect olfactory functioning at investigator's discretion
- Schizophrenia, Schizoaffective or other Psychotic Disorder
- Patients over 65 years of age
- Patients with significant allergies
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 |
|---|---|---|
| Cognitive Function Imaging and BatteryIndividuals will be placed in the fMRI scanner and complete the NBACK Cognitive Task | Device | Control, Patient |
| Sniffin SticksUsing Sniffin Sticks, olfactory functioning will be assessed using three tests: identification, discrimination, and threshold. | Device | Control, Patient |
| Cognitive BatteriesParticipants will conduct the following cognitive batteries: DSST, TMT A \& B, RAVLT | Other | Control, Patient |
Primary outcome
Olfactory Function Change using Burghart's Sniffin' Sticks
Time frame: Baseline and 6 weeks
Cognitive Function Change using NBACK, Shopping List, and Symbol Span Tests
Time frame: Baseline, 6 weeks, 3 months
3 secondary outcomes
Participant's Olfactory Identification using Sniffin' Sticks Identification Test
Time frame: Baseline and 6 weeks
Participant's Olfactory Threshold using Sniffin' Sticks Threshold Test
Time frame: Baseline and 6 weeks
Participant's Olfactory Discrimination using Sniffin' Sticks DiscriminationTest
Time frame: Baseline and 6 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 6 Sep 2017.
- BackgroundLudvigson, H.W., & Rottman, T.R. (1989). Effects of ambient odours of lavender and cloves on cognition, memory, affect, and mood. Chemical Senses, 14(4), 525-536.
- Background: PubMed 16871378Albrecht J, Wiesmann M. [The human olfactory system. Anatomy and physiology]. Nervenarzt. 2006 Aug;77(8):931-9. doi: 10.1007/s00115-006-2121-z. German.
- Background: PubMed 3676376Amsterdam JD, Settle RG, Doty RL, Abelman E, Winokur A. Taste and smell perception in depression. Biol Psychiatry. 1987 Dec;22(12):1481-5. doi: 10.1016/0006-3223(87)90108-9. No abstract available.
- Background: PubMed 11230029Austin MP, Mitchell P, Goodwin GM. Cognitive deficits in depression: possible implications for functional neuropathology. Br J Psychiatry. 2001 Mar;178:200-6. doi: 10.1192/bjp.178.3.200.
- Background: PubMed 17017547Berendse HW, Ponsen MM. Detection of preclinical Parkinson's disease along the olfactory trac(t). J Neural Transm Suppl. 2006;(70):321-5. doi: 10.1007/978-3-211-45295-0_48.
- Background: PubMed 11323080Brand G, Millot JL, Henquell D. Complexity of olfactory lateralization processes revealed by functional imaging: a review. Neurosci Biobehav Rev. 2001 Mar;25(2):159-66. doi: 10.1016/s0149-7634(01)00005-7.
- Background: PubMed 17707915Castaneda AE, Tuulio-Henriksson A, Marttunen M, Suvisaari J, Lonnqvist J. A review on cognitive impairments in depressive and anxiety disorders with a focus on young adults. J Affect Disord. 2008 Feb;106(1-2):1-27. doi: 10.1016/j.jad.2007.06.006. Epub 2007 Aug 20.
- Background: PubMed 6463130Doty RL, Shaman P, Dann M. Development of the University of Pennsylvania Smell Identification Test: a standardized microencapsulated test of olfactory function. Physiol Behav. 1984 Mar;32(3):489-502. doi: 10.1016/0031-9384(84)90269-5.
- Background: PubMed 11105660Drevets WC. Functional anatomical abnormalities in limbic and prefrontal cortical structures in major depression. Prog Brain Res. 2000;126:413-31. doi: 10.1016/S0079-6123(00)26027-5.
- Background: PubMed 12091188Frodl T, Meisenzahl EM, Zetzsche T, Born C, Groll C, Jager M, Leinsinger G, Bottlender R, Hahn K, Moller HJ. Hippocampal changes in patients with a first episode of major depression. Am J Psychiatry. 2002 Jul;159(7):1112-8. doi: 10.1176/appi.ajp.159.7.1112.
- Background: PubMed 24060620Fung PK, Robinson PA. Neural field theory of synaptic metaplasticity with applications to theta burst stimulation. J Theor Biol. 2014 Jan 7;340:164-76. doi: 10.1016/j.jtbi.2013.09.021. Epub 2013 Sep 21.
- Background: PubMed 18165282Gentner R, Wankerl K, Reinsberger C, Zeller D, Classen J. Depression of human corticospinal excitability induced by magnetic theta-burst stimulation: evidence of rapid polarity-reversing metaplasticity. Cereb Cortex. 2008 Sep;18(9):2046-53. doi: 10.1093/cercor/bhm239. Epub 2007 Dec 28.
- Individual participant dataSharing planned: Undecided
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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.
Roumen V Milev, MD FRCPC principal investigator
Queen's University Department of Psychiatry
Questions about this trial
What is this clinical trial studying?
An observational study of Depression, run by Queen's University.
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 8 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 6 Sep 2017. Status can change between updates, so confirm with the study contact before making plans.
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.
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?
Olfactory Function Change using Burghart's Sniffin' Sticks (time frame: Baseline and 6 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02804347, which also lists 33 linked publications.
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 6 Sep 2017.