The Effects of ECT and/or iTBS on Olfaction and Cognition in Patients With Depression
NCT ID: NCT02804347
Last Updated: 2017-09-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
30 participants
OBSERVATIONAL
2016-03-31
2017-07-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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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.
Cognitive Function Imaging and Battery
Individuals will be placed in the fMRI scanner and complete the NBACK Cognitive Task
Sniffin Sticks
Using Sniffin Sticks, olfactory functioning will be assessed using three tests: identification, discrimination, and threshold.
Cognitive Batteries
Participants will conduct the following cognitive batteries: DSST, TMT A \& B, RAVLT
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.
Cognitive Function Imaging and Battery
Individuals will be placed in the fMRI scanner and complete the NBACK Cognitive Task
Sniffin Sticks
Using Sniffin Sticks, olfactory functioning will be assessed using three tests: identification, discrimination, and threshold.
Cognitive Batteries
Participants will conduct the following cognitive batteries: DSST, TMT A \& B, RAVLT
Interventions
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Cognitive Function Imaging and Battery
Individuals will be placed in the fMRI scanner and complete the NBACK Cognitive Task
Sniffin Sticks
Using Sniffin Sticks, olfactory functioning will be assessed using three tests: identification, discrimination, and threshold.
Cognitive Batteries
Participants will conduct the following cognitive batteries: DSST, TMT A \& B, RAVLT
Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* 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
18 Years
65 Years
ALL
Yes
Sponsors
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Providence Healthcare
OTHER
Queen's University
OTHER
Responsible Party
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Dr. Roumen Milev
Dr. Roumen Milev
Principal Investigators
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Roumen V Milev, MD FRCPC
Role: PRINCIPAL_INVESTIGATOR
Queen's University Department of Psychiatry
References
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Other Identifiers
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6006093
Identifier Type: -
Identifier Source: org_study_id
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