Functional and Metabolic Changes in the Course of Antidepressive Treatment
The study will investigate functional and metabolic changes in the course of antidepressive treatments.
The investigators will apply different imaging methods to investigate the effects of antidepressive interventions on resting state neural activity, functional activation during cognitive and emotional stimulation, neurotransmitter concentrations as well as concentrations of brain- derived neurotrophic factor.
Panoramica dello studio
Stato
Condizioni
Descrizione dettagliata
The study will investigate functional and metabolic changes in the course of antidepressive treatments.
The investigators will apply different imaging methods to investigate the effects of antidepressive interventions on resting state neural activity, functional activiation during cognitive and emotional stimulation, neurotransmitter concentrations as well as concentrations of brain- derived neurotrophic factor.
The investigators hypothesize that antidepressive interventions modulate the excitatory glutamatergic system and thereby increase either the concentration of glutamate or the glutamate/ glutamine ratio. These metabolic changes are accompanied by altered functional activation in medial and lateral prefrontal areas during emotional and cognitive stimulation, respectively. After longterm treatment, excitatory glutamate and inhibitory gamma-aminobutyric acid concentrations adapt to a new homeostatic level which is reflected in antidepressive response or remission of symptoms. The investigators assume that the levels of glutamate and gamma-aminobutyric acid determine the amplitude of BOLD responses during emotional and cognitive stimulation. Furthermore, the investigators hypothesize that the plasma concentration of brain- derived neurotrophic factor might be a predictor for therapy response and changes in the course of treatment.
With our protocol we adhere to the rules of good scientific practice and observe all relevant laws, regulations and guidelines that pertain to the project. The investigators' study is in compliance with the Declaration of Helsinki and approved by the local ethics committee. Storage of data is in accordance with german privacy laws.
Tipo di studio
Iscrizione (Effettivo)
Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Metodo di campionamento
Popolazione di studio
Descrizione
Inclusion Criteria:
- age 18- 65 years
- current depressive episode
- males and females
- Intelligence quotient > 80
- written informed consent
Exclusion Criteria:
- neurological or psychiatric disease other than major depressive disorder
- metal implants, pacemaker, intracranial clips
- agoraphobia
- history of serious head injury
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Change in neurotransmitter concentrations (glutamate, glutamine, gamma-aminobutyric acid) from baseline to response to antidepressive intervention
Lasso di tempo: Neurotransmitter concentrations will be measured at baseline (T0), after the first antidepressive intervention (T1; 24- 48 hrs. after baseline measurement) and after patients show response or remission of symptoms (T2; an expected average of 2- 4 weeks)
|
Neurotransmitter concentrations will be measured at 3 timepoints (at baseline, after the first antidepressive intervention and after patients show response or remission of symptoms).
Measurements will show whether antidepressive interventions modulate the excitatory glutamatergic system and thereby increase either the concentration of glutamate or the glutamate/ glutamine ratio.
After longterm treatment, excitatory glutamate and inhibitory gamma-aminobutyric acid concentrations are hypothesized to adapt to a new homeostatic level which is reflected in antidepressive response or remission of symptoms.
|
Neurotransmitter concentrations will be measured at baseline (T0), after the first antidepressive intervention (T1; 24- 48 hrs. after baseline measurement) and after patients show response or remission of symptoms (T2; an expected average of 2- 4 weeks)
|
Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Change in neuronal activation patterns from baseline to response to antidepressive intervention
Lasso di tempo: Measurements will be conducted at baseline (T0), after the first antidepressive intervention (T1; 24- 48 hrs. after baseline measurement) and after patients show response or remission of symptoms (T2; an expected average of 2- 4 weeks)
|
Neuronal activation patterns will be measured at 3 timepoints (at baseline, after the first antidepressive intervention and after patients show response or remission of symptoms).
Measurements will show whether antidepressive interventions modulate resting state neural activity and functional activiation during cognitive and emotional stimulation.
We expect changes in neurotransmitter concentrations to be accompanied by altered functional activation in medial and lateral prefrontal areas during emotional and cognitive stimulation, respectively.
Furthermore, levels of glutamate and gamma-aminobutyric acid are hypothesized to determine the amplitude of BOLD responses during emotional and cognitive stimulation.
|
Measurements will be conducted at baseline (T0), after the first antidepressive intervention (T1; 24- 48 hrs. after baseline measurement) and after patients show response or remission of symptoms (T2; an expected average of 2- 4 weeks)
|
Altre misure di risultato
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Change in brain- derived neurotrophic factor concentration from baseline to response to antidepressive intervention
Lasso di tempo: Measurements will be conducted at baseline (T0), after the first antidepressive intervention (T1; 24- 48 hrs. after baseline measurement) and after patients show response or remission of symptoms (T2; an expected average of 2- 4 weeks)
|
Brain- derived neurotrophic factor concentrations will be measured at 3 timepoints (at baseline, after the first antidepressive intervention and after patients show response or remission of symptoms).
Measurements will show whether the plasma concentration of brain- derived neurotrophic factor might be a predictor for therapy response and changes in the course of treatment.
|
Measurements will be conducted at baseline (T0), after the first antidepressive intervention (T1; 24- 48 hrs. after baseline measurement) and after patients show response or remission of symptoms (T2; an expected average of 2- 4 weeks)
|
Collaboratori e investigatori
Pubblicazioni e link utili
Pubblicazioni generali
- Herrera-Melendez A, Stippl A, Aust S, Scheidegger M, Seifritz E, Heuser-Collier I, Otte C, Bajbouj M, Grimm S, Gartner M. Gray matter volume of rostral anterior cingulate cortex predicts rapid antidepressant response to ketamine. Eur Neuropsychopharmacol. 2021 Feb;43:63-70. doi: 10.1016/j.euroneuro.2020.11.017. Epub 2020 Dec 11.
- Gartner M, Aust S, Bajbouj M, Fan Y, Wingenfeld K, Otte C, Heuser-Collier I, Boker H, Hattenschwiler J, Seifritz E, Grimm S, Scheidegger M. Functional connectivity between prefrontal cortex and subgenual cingulate predicts antidepressant effects of ketamine. Eur Neuropsychopharmacol. 2019 Apr;29(4):501-508. doi: 10.1016/j.euroneuro.2019.02.008. Epub 2019 Feb 26.
- Basso L, Bonke L, Aust S, Gartner M, Heuser-Collier I, Otte C, Wingenfeld K, Bajbouj M, Grimm S. Antidepressant and neurocognitive effects of serial ketamine administration versus ECT in depressed patients. J Psychiatr Res. 2020 Apr;123:1-8. doi: 10.1016/j.jpsychires.2020.01.002. Epub 2020 Jan 16. Erratum In: J Psychiatr Res. 2020 May;124:143.
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Completamento primario (Effettivo)
Completamento dello studio (Effettivo)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Stima)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- EMOKET-103/13
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .
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