The Effects of ECT and/or iTBS on Olfaction and Cognition in Patients With Depression

NCT02804347 | Completed

• 1 other identifier: 6006093
• Study Type: observational
• Target: 30
• Locations: 0 countries
• Sites: N/A

Brief 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. 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.

Conditions

Depression

Keywords

Olfactory Dysfunction; Electroconvulsive Therapy; Theta Burst Stimulation

Outcome Measures

Primary Outcomes (2)

• Olfactory Function Change using Burghart's Sniffin' Sticks

  Baseline and 6 weeks

• Cognitive Function Change using NBACK, Shopping List, and Symbol Span Tests

  Baseline, 6 weeks, 3 months

Secondary Outcomes (3)

• Participant's Olfactory Identification using Sniffin' Sticks Identification Test

  Baseline and 6 weeks

• Participant's Olfactory Threshold using Sniffin' Sticks Threshold Test

  Baseline and 6 weeks

• Participant's Olfactory Discrimination using Sniffin' Sticks DiscriminationTest

  Baseline and 6 weeks

Study Arms (2)

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.

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.

Device: Cognitive Function Imaging and Battery; Device: Sniffin Sticks; Other: Cognitive Batteries

Interventions

Cognitive Function Imaging and Battery DEVICE

Individuals will be placed in the fMRI scanner and complete the NBACK Cognitive Task

Control; Patient

Sniffin Sticks DEVICE

Using Sniffin Sticks, olfactory functioning will be assessed using three tests: identification, discrimination, and threshold.

Control; Patient

Cognitive Batteries OTHER

Participants will conduct the following cognitive batteries: DSST, TMT A \& B, RAVLT

Control; Patient

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Queen's University: lead
• Providence Healthcare: collaborator

Related Publications (33)

• 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.

  BACKGROUND

• 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.

  PMID: 16871378 BACKGROUND

• Amsterdam 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.

  PMID: 3676376 BACKGROUND

• Austin 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.

  PMID: 11230029 BACKGROUND

• Berendse 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.

  PMID: 17017547 BACKGROUND

• Brand 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.

  PMID: 11323080 BACKGROUND

• Castaneda 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.

  PMID: 17707915 BACKGROUND

• Doty 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.

  PMID: 6463130 BACKGROUND

• Drevets 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.

  PMID: 11105660 BACKGROUND

• Frodl 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.

  PMID: 12091188 BACKGROUND

• Fung 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.

  PMID: 24060620 BACKGROUND

• Gentner 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.

  PMID: 18165282 BACKGROUND

• Golinkoff 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.

  PMID: 2527885 BACKGROUND

• Gross-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.

  PMID: 8043710 BACKGROUND

• Hawkes C. Olfaction in neurodegenerative disorder. Mov Disord. 2003 Apr;18(4):364-72. doi: 10.1002/mds.10379.

  PMID: 12671941 BACKGROUND

• Kellner CH, Fink M. The efficacy of ECT and "treatment resistance". J ECT. 2002 Mar;18(1):1-2. doi: 10.1097/00124509-200203000-00001. No abstract available.

  PMID: 11925510 BACKGROUND

• Lombion-Pouthier S, Vandel P, Nezelof S, Haffen E, Millot JL. Odor perception in patients with mood disorders. J Affect Disord. 2006 Feb;90(2-3):187-91. doi: 10.1016/j.jad.2005.11.012. Epub 2005 Dec 27.

  PMID: 16376994 BACKGROUND

• Martzke JS, Kopala LC, Good KP. Olfactory dysfunction in neuropsychiatric disorders: review and methodological considerations. Biol Psychiatry. 1997 Oct 15;42(8):721-32. doi: 10.1016/s0006-3223(96)00442-8. No abstract available.

  PMID: 9325566 BACKGROUND

• Negoias S, Croy I, Gerber J, Puschmann S, Petrowski K, Joraschky P, Hummel T. Reduced olfactory bulb volume and olfactory sensitivity in patients with acute major depression. Neuroscience. 2010 Aug 11;169(1):415-21. doi: 10.1016/j.neuroscience.2010.05.012. Epub 2010 May 13.

  PMID: 20472036 BACKGROUND

• Pause BM, Miranda A, Goder R, Aldenhoff JB, Ferstl R. Reduced olfactory performance in patients with major depression. J Psychiatr Res. 2001 Sep-Oct;35(5):271-7. doi: 10.1016/s0022-3956(01)00029-2.

  PMID: 11591429 BACKGROUND

• Plewnia C, Pasqualetti P, Grosse S, Schlipf S, Wasserka B, Zwissler B, Fallgatter A. Treatment of major depression with bilateral theta burst stimulation: a randomized controlled pilot trial. J Affect Disord. 2014 Mar;156:219-23. doi: 10.1016/j.jad.2013.12.025. Epub 2013 Dec 28.

  PMID: 24411682 BACKGROUND

• Rolls ET, Kringelbach ML, de Araujo IE. Different representations of pleasant and unpleasant odours in the human brain. Eur J Neurosci. 2003 Aug;18(3):695-703. doi: 10.1046/j.1460-9568.2003.02779.x.

  PMID: 12911766 BACKGROUND

• Satoh S, Morita N, Matsuzaki I, Konishi T, Nakano T, Minoshita S, Arizono H, Saito S, Ayabe AS. Relationship between odor perception and depression in the Japanese elderly. Psychiatry Clin Neurosci. 1996 Oct;50(5):271-5. doi: 10.1111/j.1440-1819.1996.tb00563.x.

  PMID: 9201790 BACKGROUND

• Seo HS, Jeon KJ, Hummel T, Min BC. Influences of olfactory impairment on depression, cognitive performance, and quality of life in Korean elderly. Eur Arch Otorhinolaryngol. 2009 Nov;266(11):1739-45. doi: 10.1007/s00405-009-1001-0. Epub 2009 Jun 2.

  PMID: 19488777 BACKGROUND

• Serby M, Larson P, Kalkstein D. Olfactory sense in psychoses. Biol Psychiatry. 1990 Nov 1;28(9):830. doi: 10.1016/0006-3223(90)90520-c. No abstract available.

  PMID: 2257290 BACKGROUND

• Small DM, Jones-Gotman M, Zatorre RJ, Petrides M, Evans AC. Flavor processing: more than the sum of its parts. Neuroreport. 1997 Dec 22;8(18):3913-7. doi: 10.1097/00001756-199712220-00014.

  PMID: 9462465 BACKGROUND

• Snaith RP, Hamilton M, Morley S, Humayan A, Hargreaves D, Trigwell P. A scale for the assessment of hedonic tone the Snaith-Hamilton Pleasure Scale. Br J Psychiatry. 1995 Jul;167(1):99-103. doi: 10.1192/bjp.167.1.99.

  PMID: 7551619 BACKGROUND

• Steiner JE, Lidar-Lifschitz D, Perl E. Taste and odor: reactivity in depressive disorders, a multidisciplinary approach. Percept Mot Skills. 1993 Dec;77(3 Pt 2):1331-46. doi: 10.2466/pms.1993.77.3f.1331.

  PMID: 8170789 BACKGROUND

• Swiecicki L, Zatorski P, Bzinkowska D, Sienkiewicz-Jarosz H, Szyndler J, Scinska A. Gustatory and olfactory function in patients with unipolar and bipolar depression. Prog Neuropsychopharmacol Biol Psychiatry. 2009 Aug 1;33(5):827-34. doi: 10.1016/j.pnpbp.2009.03.030. Epub 2009 Apr 5.

  PMID: 19345708 BACKGROUND

• Van Toller S, Reed MK. Brain electrical activity topographical maps produced in response to olfactory and chemosensory stimulation. Psychiatry Res. 1989 Sep;29(3):429-30. doi: 10.1016/0165-1781(89)90112-1. No abstract available.

  PMID: 2608810 BACKGROUND

• Warner MD, Peabody CA, Csernansky JG. Olfactory functioning in schizophrenia and depression. Biol Psychiatry. 1990 Feb 15;27(4):457-8. doi: 10.1016/0006-3223(90)90557-i. No abstract available.

  PMID: 2178695 BACKGROUND

• Weismann M, Yousry I, Heuberger E, Nolte A, Ilmberger J, Kobal G, Yousry TA, Kettenmann B, Naidich TP. Functional magnetic resonance imaging of human olfaction. Neuroimaging Clin N Am. 2001 May;11(2):237-50, viii.

  PMID: 11489737 BACKGROUND

• Wiesmann M, Kopietz R, Albrecht J, Linn J, Reime U, Kara E, Pollatos O, Sakar V, Anzinger A, Fesl G, Bruckmann H, Kobal G, Stephan T. Eye closure in darkness animates olfactory and gustatory cortical areas. Neuroimage. 2006 Aug 1;32(1):293-300. doi: 10.1016/j.neuroimage.2006.03.022. Epub 2006 May 2.

  PMID: 16631383 BACKGROUND

MeSH Terms

Conditions

Depression

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Study Officials

• Roumen V Milev, MD FRCPC

  Queen's University Department of Psychiatry

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr. Roumen Milev

Study Record Dates

• First Submitted: June 2, 2016
• First Posted: June 17, 2016
• Study Start: March 1, 2016
• Primary Completion: July 1, 2017
• Study Completion: July 1, 2017
• Last Updated: September 6, 2017

Record last verified: 2017-09