Trial document




This trial has been registered retrospectively.
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  DRKS00016497

Trial Description

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Title

Neuronal olfactory-emotional interaction in depression

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Trial Acronym

OLSA

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URL of the Trial

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Brief Summary in Lay Language

The present study focuses on the impact of olfactory stimulation on salience processing in people with major depressive disorder. Salience processing refers to the "relevance" of surrounding Stimuli. A warm, freshly brewed cup of coffee for example would certainly attract several people early in the morning.
Prior studies have shown, that this salience processing is impaired in major depressed patients. Especially when it comes to the presentation of positive stimuli, such as smiling facial expressions. Brain structures involved in salience processing are also involved in olfactory Information processing. Therefore we hypothesize, that olfactory stimulation can influence salience processing.

The present study will include two groups, the control group (helathy controls) and the study group (major depressed patients).
During the experimental set up, consisting of three trials, participants are asked to react to smiling facial expressions via button pressing. In one of the trials participants will perceive a lilac odor presentation.

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Brief Summary in Scientific Language

Major depressed (MD) patients present structurally and functionally altered salience processing regions. These affected brain areas receive intense input from the olfactory bulb and the primary olfactory cortex. We therefore aim to modify the salience activity in MD patients by olfactory stimulation.

The study subjects will participate in an event-related fmri design consisting of an emotional oddball paradigm with infrequent positive facial expressions embedded in frequent neutral facial expressions. The experiment will consist of three trials: 1) a blank trial with facial expressions only, 2) facial expressions presented in the same paradigm as in the blank trial, this time accompanied by olfactory stimulation and 3) a control condition based on mechanical trigeminal Stimulation. The mechanical Stimulation will be done by an air flow on the forehead.

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Do you plan to share individual participant data with other researchers?

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Description IPD sharing plan:

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Organizational Data

  •   DRKS00016497
  •   2019/03/14
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  •   yes
  •   Approved
  •   EK404102017, Ethikkommission der Medizinischen Fakultät der Technischen Universität Dresden
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Secondary IDs

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Health Condition or Problem studied

  •   F32.2 -  Severe depressive episode without psychotic symptoms
  •   F32.1 -  Moderate depressive episode
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Interventions/Observational Groups

  •   Healthy controls (validated by the application of PHQ and BDI)
    Controls were recruited by public announcement in the technical University, the smell and taste Center and the Intranet of the University Hospital Dresden.
    The study participants are invited for one appointement where they go through the following steps:
    - Filling in of questionnaires on an iPad (approx. 30 min)
    - fMRI measurements (structural T1, Bulbvolume measurement, functional EPI) (approx. 45 min)
    - olfactory testing (olfactory threshold, olfactory identification) approx. 20 min
  •   Patients (F32.1/F32.2, SCID) were recruited in the University Hospital and affiliated therapists.
    The study participants are invited for one appointement where they go through the following steps:
    - Filling in of questionnaires on an ipad (approx. 30 min)
    - MRI measurements (structural T1, Bulbvolume measurement, EPI) (approx. 45 min)
    - olfactory testing (olfactory threshold, olfactory identification) (approx. 20 minutes)
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Characteristics

  •   Non-interventional
  •   Other
  •   Non-randomized controlled trial
  •   Open (masking not used)
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  •   Other
  •   Basic research/physiological study
  •   Parallel
  •   N/A
  •   N/A
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Primary Outcome

Difference in olfactory function in the peripheral vs the central dimension (olfactory identification vs olfactory threshold), changes in oddball - reaction times during the three different trials, changes of BOLD Signal according to the different trials (1) visual Stimulation only 2) visual and olfactory Stimulation 3) visual and mechanical trigeminal Stimulation).

(The exact duration is described in Arm 1 and Arm 2 above).

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Secondary Outcome

Evaluation of olfactory function in group comparison (control vs study group), evaluation of changes of BOLD Signal and oddball reaction times according to the different trials in group comparison, relation of anhedonic symptomatology and related questionnaire data to olfactory function and BOLD Signal in group comparison.

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • Medical Center 
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Recruitment

  •   Actual
  •   2018/08/17
  •   60
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   80   Years
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Additional Inclusion Criteria

For the Patient sample: a diagnosed Major Depression (SCID)

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Exclusion Criteria

Exclusion criteria are 1) patients with a history of schizophrenia and/or bipolar disorder 2) history of severe head injury; 3) dependence on alcohol or other substances; 4) concurrent neurological or otorhinolaryngical illness; 5) anosmia; 6) contraindication for MRI.

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Addresses

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    • Klinik für Psychotherapie und Psychosomatik, Uniklinikum Carl Gustav Carus Dresden
    • Ms.  Jun.-Prof.Dr.habil.  Ilona  Croy 
    • Fetscherstraße 74
    • 01307  Dresden
    • Germany
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    • Forschergruppe Neuromarker, Klinik für Psychotherapie und Psychosomatik,Uniklinikum Carl Gustav Carus Dresden
    • Ms.  Jun.-Prof.Dr.habil.  Ilona  Croy 
    • Fetscherstraße 74
    • 01307  Dresden
    • Germany
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    • Forschergruppe Neuromarker, Klinik für Psychotherapie und Psychosomatik,Uniklinikum Carl Gustav Carus Dresden
    • Ms.  Carina  Köppel 
    • Fetscherstraße 74
    • 01307  Dresden
    • Germany
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Sources of Monetary or Material Support

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    • Promotionsprogramm der Medizinischen Fakultät, TU Dresden, welches finanziell von der Dr. Georg E. und Marianne Kosing-Stiftung unterstützt wird
    • Fetscherstraße 74
    • 01307  Dresden
    • Germany
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Status

  •   Recruiting ongoing
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Trial Publications, Results and other Documents

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