Trial document
DRKS00012970
Trial Description
Title
Change in olfactory perception during psychotherapeutic treatment of patients with depressive disorder
Trial Acronym
COPD
URL of the Trial
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Brief Summary in Lay Language
Empirical studies show that patients with a depressive disorder have deficits in olfactory perception. However, the meaning of these deficits has not yet been conclusively clarified. The aim of the planned investigation is to check whether the olfactory performance is improved in the course of an improvement of the depressive symptoms, or whether the deficits persist. In addition, it should be checked whether the initial olfactory performance has an influence on the recovery potential of the patients suffering from depressive disorders. For this aim, the olfactory performance of patients with Major Depression will be examined before, during and after a psychotherapeutic treatment.
Brief Summary in Scientific Language
Deficits of olfactory perception are widespread in mental disorders, including depression, posttraumatic stress disorder, and obsessive-compulsive disorder. Especially in depressive disorder, all dimensions of olfactory perception appear to be deficient. However, the findings are heterogeneous, and there are also conflictive findings. It is also not known whether the olfactory deficits are a secondary symptom of depressive disorders, regressing in the course of the recovery from depressive symptoms, or whether the olfactory deficits represent a biological marker of dysfunctional cerebral processing. If the first assumption is true, it is expected that the olfactory performance improves in the course of the psychotherapeutic treatment. If the second assumption is true, it is expected that the severity of the olfactory deficits predicts the change of symptom severity in the course of a psychotherapeutic treatment . The aim of the planned study is to answer these questions and to examine the relationship between olfactory perception depressive symptoms.
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
- DRKS00012970
- 2017/10/24
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- yes
- Approved
- 16-11, Ethikkomission der Fakultät für Empirische Humanwissenschaften und Wirtschaftswissenschaft der Universität des Saarlandes
Secondary IDs
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Health Condition or Problem studied
- F32 - Depressive episode
- F33 - Recurrent depressive disorder
Interventions/Observational Groups
- The olfactory perception (perception threshold, discrimination, identification) of Patients with depressive disorder will be examined at three time points (before the start of a psychotherapy, after the 12th and after the 24th session). In addition, the symptom severity will be assessed by questionnaires (BDI-II and BSI) and clinical diagnostics are assessed by the SKID.
- The olfactory perception and the symptom severity of healthy controls will be assessed at the same time points and by the same measurements as described in Arm 1.
Characteristics
- Non-interventional
- Other
- Non-randomized controlled trial
- Open (masking not used)
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- Other
- Treatment
- Parallel
- N/A
- N/A
Primary Outcome
Examination of the presence of deficits in olfactory perception (perception threshold, discrimination, identification) in patients with depression compared to a healthy control group adjusted for age and sex. The olfactory perception is measured in all dimensions with the Sniffin 'Sticks.
Change of the olfactory perception (perception threshold, discrimination, identification) in the course of the therapy.
Predictability of the change in symptom stress, recorded by the BDI, in the course of the therapy based on the olfactory perception.
Three survey days: 1) before the start of therapy (during or after the probatory sessions), 2) after the 12th therapies session, 3) after the 24th therapies session.
Secondary Outcome
Diagnostic Interview using SKID. Examination of the correlation between olfactory performance and the severity of comorbidities like e.g. anxiety disorders (BSI).
Countries of Recruitment
- Germany
Locations of Recruitment
- other
Recruitment
- Actual
- 2017/10/12
- 60
- Monocenter trial
- National
Inclusion Criteria
- Both, male and female
- 18 Years
- no maximum age
Additional Inclusion Criteria
Patient sample: Depressive disorder as primary diagnosis, participation in cognitive behavioral therapy
Control group: healthy volunteers
Exclusion Criteria
Patients: Drug or substance abuse, permanent use of medication (exception: oral contraceptives or occasional use of headache tablets up to one week before the beginning of the study, prescribed psychopharmaceuticals)
Control group: Mental disorder, drug or substance abuse, permanent administration of medications (exception: oral contraceptives or occasional use of headache tablets up to one week before the start of the study)
Addresses
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start of 1:1-Block address primary-sponsor
- Universität des SaarlandesKlinische Psychologie und Psychotehrapie
- Ms. Prof. Dr. Tanja Michael
- Campus, Geb. A1.3
- 66123 Saarbrücken
- Germany
end of 1:1-Block address primary-sponsorstart of 1:1-Block address contact primary-sponsor- ++49 +681 302 71000
- ++49 +681 302 4437
- t.michael at mx.uni-saarland.de
- http://URL der Einrichtung: http://www.uni-saarland.de/lehrstuhl/michael/startseite.html
end of 1:1-Block address contact primary-sponsor -
start of 1:1-Block address scientific-contact
- Universität des SaarlandesKlinische Psychologie und Psychotherapie
- Mr. Christian Schanz
- Campus, Geb. A1.3
- 66123 Saarbrücken
- Germany
end of 1:1-Block address scientific-contactstart of 1:1-Block address contact scientific-contact- ++49 +681 302 71005
- ++49 +681 302 4437
- christian.schanz at uni-saarland.de
- http://URL der Einrichtung: http://www.uni-saarland.de/lehrstuhl/michael/startseite.html
end of 1:1-Block address contact scientific-contact -
start of 1:1-Block address public-contact
- Universität des SaarlandesKlinische Psychologie und Psychotherapie
- Mr. Christian Schanz
- Campus, Geb. A1.3
- 66123 Saarbrücken
- Germany
end of 1:1-Block address public-contactstart of 1:1-Block address contact public-contact- ++49 +681 302 71005
- ++49 +681 302 4437
- christian.schanz at uni-saarland.de
- http://URL der Einrichtung: http://www.uni-saarland.de/lehrstuhl/michael/startseite.html
end of 1:1-Block address contact public-contact
Sources of Monetary or Material Support
-
start of 1:1-Block address materialSupport
- Universität des Saarlandes, Klinische Psychologie und Psychotherapie
- Campus, Geb. A1.3
- 66123 Saarbrücken
- Germany
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Status
- Recruiting ongoing
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Trial Publications, Results and other Documents
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