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Functional and Metabolic Changes in the Course of Antidepressive Treatment

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ClinicalTrials.gov Identifier: NCT02099630
Recruitment Status : Completed
First Posted : March 31, 2014
Last Update Posted : February 7, 2020
Sponsor:
Information provided by (Responsible Party):
Simone Grimm, Charite University, Berlin, Germany

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
Major Depressive Disorder

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.

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Study Type : Observational [Patient Registry]
Actual Enrollment : 40 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 3 Months
Study Start Date : March 2014
Actual Primary Completion Date : November 2019
Actual Study Completion Date : February 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Antidepressants




Primary Outcome Measures :
  1. Change in neurotransmitter concentrations (glutamate, glutamine, gamma-aminobutyric acid) from baseline to response to antidepressive intervention [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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.


Biospecimen Retention:   Samples With DNA
whole blood


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
depressive patients from a primary care clinic
Criteria

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
Additional Information:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Simone Grimm, Research Fellow, Charite University, Berlin, Germany
ClinicalTrials.gov Identifier: NCT02099630    
Other Study ID Numbers: EMOKET-103/13
First Posted: March 31, 2014    Key Record Dates
Last Update Posted: February 7, 2020
Last Verified: February 2020
Additional relevant MeSH terms:
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Depressive Disorder
Depressive Disorder, Major
Mood Disorders
Mental Disorders