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Trial · NCT03395314

Outcomes21

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

TypeOutcomeTime framePopulationUnitsMeasured as
PRIMARYChange in Suicidal Thoughts as Measured by Item 10 on the Montgomery-Asberg Depression Scale (MADRS)Timepoints will be baseline, 1hr post-infusion and at 1, 3, 7, 14, & 28 days after infusion.Intention to treat.units on a scaleLEAST_SQUARES_MEAN
PRIMARYChange in Suicidality as Measured by the Columbia Suicide Severity Rating Scale (C-SSRS)Timepoints will be baseline, 1hr post-infusion and at 1, 3, 7, 14, & 28 days after infusion.Intention to treat.score on a scaleLEAST_SQUARES_MEAN
PRIMARYChange in Suicidality as Measured by Item-12 on the Quick Inventory of Depressive Symptomatology (QIDS SR-16)Timepoints will be baseline, 1hr post-infusion and at 1, 3, 7, 14, & 28 days after infusion.Intention to treat.score on a scaleLEAST_SQUARES_MEAN
PRIMARYChange in Suicidality as Measured by Item 9 on Beck Depression InventoryTimepoints will be baseline, 1hr post-infusion and at 1, 3, 7, 14, & 28 days after infusion.Intention to treat.units on a scaleLEAST_SQUARES_MEAN
SECONDARYChange in Montgomery-Asberg Depression Rating Scale (MADRS) Total ScoreTimepoints will be baseline, 1hr post-infusion and at 1, 3, 7, 14, & 28 days after infusion.Intention to treat.score on a scaleLEAST_SQUARES_MEAN
SECONDARYChange in Beck Depression Inventory ScoreTimepoints will be baseline, 1hr post-infusion and at 1, 3, 7, 14, & 28 days after infusion.Intention to treat.score on a scaleLEAST_SQUARES_MEAN
SECONDARYChange in Beck Anxiety Inventory ScoreTimepoints will be baseline, 1hr post-infusion and at 1, 3, 7, 14, & 28 days after infusion.Intention to treat.score on a scaleLEAST_SQUARES_MEAN
SECONDARYChange in Zanarini Rating Scale for Borderline Personality DisorderTimepoints will be baseline and at 1, 3, 7, 14, & 28 days after infusion.Intention to treat.score on a scaleLEAST_SQUARES_MEAN
SECONDARYChange in Preferred Distance in Stop-distance Paradigm (SDP)Timepoints will be at baseline and 3, 7, 14, 28 days after infusionIntention to treat.distance in inchesLEAST_SQUARES_MEAN
SECONDARYChange in Behavior in the Economic Trust Game - CooperationTimepoints will be at baseline and 3, 7, 14, 28 days after infusionIntention to treat.proportion of amount returnedLEAST_SQUARES_MEAN
SECONDARYChange in Social Adjustment Scale Self Report (SAS-SR) Short Version ScoreTimepoints will be at baseline and 3, 7, 14, 28 days after infusionIntention to treat.score on a scaleLEAST_SQUARES_MEAN
SECONDARYChange in Brief Pain Inventory Score - IntensityTimepoints will be at baseline, and post-infusion 1hr, and days 1, 3, 7, 14, & 28.Intention to treat.score on a scaleLEAST_SQUARES_MEAN
SECONDARYChange in Brief Pain Inventory Score - InterferenceTimepoints will be at baseline, and post-infusion 1hr, and days 1, 3, 7, 14, & 28.Intention to treat.score on a scaleLEAST_SQUARES_MEAN
SECONDARYChange in Clinician-Administered Dissociative States Scale (CADSS) ScoreTimepoints: pre- infusion, during infusion +20, +40 minutes, and post-infusion 40 minutes.Intention to treat.score on a scaleLEAST_SQUARES_MEAN
SECONDARYChange in Adverse EventsTimepoints: Continuous monitoring throughout infusion; post-infusion days 1, 3, 7, 14, 28.ParticipantsCOUNT_OF_PARTICIPANTS
SECONDARYChange in 'Reading the Mind in the Eyes' Test (RMET) ScoreTimepoints: at baseline and 3, 7, 14, 28 days after infusion.Intention to treat.score on a scaleLEAST_SQUARES_MEAN
SECONDARYChange in Brief Psychiatric Rating Scale (BPRS) Total ScoresTimepoints: pre-infusion, during infusion +20, +40 minutes, post-infusion +40 minutesIntention to treat.score on a scaleLEAST_SQUARES_MEAN
SECONDARYChange in Beck Suicide Scale Total ScoreTimepoints will be baseline, 1hr post-infusion and at 1, 3, 7, 14, & 28 days after infusion.Intention to treat.score on a scaleLEAST_SQUARES_MEAN
OTHER_PRE_SPECIFIEDChange in Bias Scores on the Implicit Association Tests (IAT) of Death, Escape and Self Harm Imagery.Timepoints: at baseline and 1, 3, 7, 28 days after infusion.
OTHER_PRE_SPECIFIEDChange in Resting State Electroencephalography (EEG)Timepoints: at baseline and 1 and/or 7 days after infusion.

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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