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Trial · NCT05710250

Registered outcomes15

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

ListOutcomeTime frameDescription
PrimaryChange from Baseline in Glumatate concentrations (mM) at 8 Weeksbaseline and 8 weeksGlumatate concentrations (mM) are measured by magnetic resonance spectrocopy in left hippocampal formation
SecondaryChange in left hippocampal formation volumes (mm^3) measured on MRI 3D T1w sequencebaseline and 8 weeks
SecondaryChange in right amygdala volumes (mm^3) measured on MRI 3D T1w sequencebaseline and 8 weeks
SecondaryChange in posterior cingulate volumes (mm^3) measured on MRI 3D T1w sequencebaseline and 8 weeks
SecondaryChang in overall brain volume measured on MRI 3D T1w sequencebaseline and 8 weeks
SecondaryChange in score the Feeling of knowing task (FOK task)baseline and 8 weks
FOK task for episodic memory performance includes 4 distincts steps : (1) a learning phase of a 60 pairs of words, (2) a cued recall phase (number of correct recalls /60 ; number of incorrect recalls /60), (3) feeling of knowing phase, (4) recognition phase (number of correct recognition /60 ; number of incorrect recognition /60)
SecondaryChange in score of the Trail Making Test (TMT)baseline and 8 weeks
TMT consists of two parts. In the first part (A), the subject must connect with a pen in the correct order 25 numbers from 1 to 25, which are distributed randomly. In the second part (B), the subject must connect with a pencil in the correct order an alternation of 13 numbers from 1 to 13 and 12 letters from A to L, which are also distributed randomly. The time in seconds to complete each part is measured.
SecondaryChange in score of Stroop testbaseline and 8 weeksThe test includes 3 phases. In each one, participant have to give maximum of correct answer. Score ranges from 0 to 100 for each phase
SecondaryChange in score of N-Back testBaseline and at 8 weeksNumber of correct answer (yes or no). Total score /23
SecondaryChange in score of attentional network test (ANT)baseline and 8 weeks
Test (ANT) is a computerized testing measure that analyses the three components of attention network : alerting, orienting, executive control. Each of these three attention components is measured in time.
SecondaryChange in score of the number memory taskbaseline and 8 weeksNumber memory score in direct order, ranges from 0 to 16. Number memory score in indirect order, ranges from 0 to 16
SecondaryChange in score of the Hospital Anxiety and Depression Scale (HADS)baseline and 8 weeks
Anxio-depressive symptomatology based on the HADS score. The questionnaire is divided in two subscales, one for anxiety and one for depression. Each subscore ranges from 0 to 21. Scores greater than or equal to 11 on either scale indicate anxious or depressive symptomatology.
SecondaryChange in score of the Perceived Stress Scale (PSS)baseline and 8 weeksAnxio-depressive symptomatology based on the PSS score. The total score ranges from 0 to 40. Higher scores reflect greater stress level.
SecondaryChange in score of the Columbia Suicide Severity Rating Scale (C-SSRS)baseline and 8 weeks
Evaluation of suicidality through the C-SSRS. The suicidal ideation severity subscale ranges from 1 to 5 (with higher number indicating more severe ideation). The intensity of ideation subscale includes 5 questions each one ranging from 1 to 5 (with higher number indicating more intense ideation). The suicidal behavior subscale includes 4 yes/no questions. The suicidal behavior lethality subscale inquires about the level of actual or potential medical damage.
SecondaryChange in score of the World Health Organization Quality of Life (WHOQOL)baseline and 8 weeksQuality of life based on the WHOQOL score. The total score ranges from 0 to 100. Higher scores reflect better health.

Source ClinicalTrials.govtrials-2026-11-12-0.5.0

Sources 3

  • ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
  • ClinicalTrials.govNo license stated
  • NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
  • ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
  • ClinicalTrials.govnone stated
  • NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

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