Functional and Metabolic Changes in the Course of Antidepressive Treatment

Sponsor
Charite University, Berlin, Germany (Other)
Overall Status
Completed
CT.gov ID
NCT02099630
Collaborator
(none)
40
71.1

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    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.

    Study Design

    Study Type:
    Observational [Patient Registry]
    Actual Enrollment :
    40 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Study Start Date :
    Mar 1, 2014
    Actual Primary Completion Date :
    Nov 1, 2019
    Actual Study Completion Date :
    Feb 1, 2020

    Outcome Measures

    Primary Outcome Measures

    1. Change in neurotransmitter concentrations (glutamate, glutamine, gamma-aminobutyric acid) from baseline to response to antidepressive intervention [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.

    Secondary Outcome Measures

    1. Change in neuronal activation patterns from baseline to response to antidepressive intervention [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.

    Other Outcome Measures

    1. Change in brain- derived neurotrophic factor concentration from baseline to response to antidepressive intervention [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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 65 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Charite University, Berlin, Germany

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Simone Grimm, Research Fellow, Charite University, Berlin, Germany
    ClinicalTrials.gov Identifier:
    NCT02099630
    Other Study ID Numbers:
    • EMOKET-103/13
    First Posted:
    Mar 31, 2014
    Last Update Posted:
    Feb 7, 2020
    Last Verified:
    Feb 1, 2020
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Feb 7, 2020