Trial · NCT03395314
Registered outcomes21
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 20 of 21
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change 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. | The MADRS test includes 10 items and uses a 0 to 6 severity scale for each item, with higher scores indicating increasing depressive symptoms. Scores are averaged across items and can range from 0 to 6 (with 0 indicating enjoying life, and 6 indicating explicit plans for suicide). Outcome description updated when results were entered. |
| Primary | Change 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. | Suicide Rating Scale from 1-5; higher numbers indicate increased suicidal thinking. |
| Primary | Change 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. | The Quick Inventory of Depressive Symptomatology (QIDS SR-16) is a a self-report measure of depression. Each item is scored from 0-3. Higher scores denote more severe load of depressive symptoms. Item 12 measures thoughts of death or suicide from 0 (no thoughts) to 3 (specific suicide plan or action.). Presented is the mean score across items with a range of 0 to 3 where the higher score indicates greater depressive symptoms. Outcome description was updated at the time of results entry. |
| Primary | Change in Suicidality as Measured by Item 9 on Beck Depression Inventory | Timepoints will be baseline, 1hr post-infusion and at 1, 3, 7, 14, & 28 days after infusion. | When the test is scored, a value of 0 to 3 is assigned for each answer and then the total score is used to quantify the participant's degree of depression from 0 = no depression to 63 = maximally severe depression. Item 9 measures degree of suicidal thoughts or wishes from 0 = no thoughts to 3 = suicidal intent. |
| Secondary | Change in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score | Timepoints will be baseline, 1hr post-infusion and at 1, 3, 7, 14, & 28 days after infusion. | The MADRS scale measures the depression level of a participant. The total score was derived by adding the scores of the following 10 items: 1, Apparent sadness; 2, Reported sadness; 3, Inner tension; 4, Reduced sleep; 5, Reduced appetite; 6, Concentration difficulties; 7, Lassitude; 8, Inability to feel; 9, Pessimistic thoughts; 10, Suicidal thoughts. Each item was scored using a scale of 0 to 6 (a higher score indicates increased severity). The maximum total score is 60; 0, no depression; 60, severely depressed. |
| Secondary | Change in Beck Depression Inventory Score | Timepoints will be baseline, 1hr post-infusion and at 1, 3, 7, 14, & 28 days after infusion. | The Beck Depression Inventory (BDI) consisted of twenty-one questions about how the subject has been feeling in the last week. Each question has a set of at least four possible answer choices, ranging in intensity. When the test is scored, a value of 0 to 3 is assigned for each answer and then the total score is used to quantify the participant's degree of depression from 0 = no depression to 63 = maximally severe depression. |
| Secondary | Change in Beck Anxiety Inventory Score | Timepoints will be baseline, 1hr post-infusion and at 1, 3, 7, 14, & 28 days after infusion. | The Beck Anxiety Inventory (BDI) consisted of twenty-one questions about how the subject has been feeling in the last week. Each question has a set of at least four possible answer choices, ranging in intensity. When the test is scored, a value of 0 to 3 is assigned for each answer and then the total score is used to quantify the participant's degree of anxiety from 0 = no anxiety to 63 = maximally severe anxiety. |
| Secondary | Change in Zanarini Rating Scale for Borderline Personality Disorder | Timepoints will be baseline and at 1, 3, 7, 14, & 28 days after infusion. | A dimensional self-report measure of BPD symptoms that consists of 9 items scored on a 4 point likert scale. Scores range of 0 = minimally symptomatic to 28 = maximally symptomatic for symptoms of Borderline Personality Disorder. Originally, 1hr post-infusion was included as a time frame but this was not collected at this time frame. |
| Secondary | Change in Preferred Distance in Stop-distance Paradigm (SDP) | Timepoints will be at baseline and 3, 7, 14, 28 days after infusion | The stop-distance paradigm is a measure of preferred interpersonal distance (PID). Subjects begin the task standing face-to-face and 6 feet away from a test confederate. On each of 3 trials, the confederate slowly approaches the subject. The subjects are instructed to say "stop" to indicate their 1) preferred conversational distance, then a closer distance 2) "if you start to feel uncomfortable". After each "stop", toe to toe distance is measured using a tape measure, and mean PID for the three trials is computed separately for conversational and uncomfortable distance. A computerized version of the task may also be implemented for remote visits and administered in place of the in-person task. |
| Secondary | Change in Behavior in the Economic Trust Game - Cooperation | Timepoints will be at baseline and 3, 7, 14, 28 days after infusion | The trust game is a multi-round economic exchange game. There are two roles in the game: investor and trustee. Study participants will play as the trustee. Each round, the investor is given a set number of points and can send any amount to the trustee. The investment triples and the trustee decides how much to repay the investor. Outcome measures are cooperation (amount returned to the investor) and coaxing (amount returned to investor on trials when poor prior returns from trustee have led investor to decrease investment). Cooperation was used as part of the evaluation in this study- coaxing was not. Outcome measure description was updated at the time of results entry. |
| Secondary | Change in Social Adjustment Scale Self Report (SAS-SR) Short Version Score | Timepoints will be at baseline and 3, 7, 14, 28 days after infusion | This questionaire measures expressive and instrumental performance over the past two weeks in six role areas: (1) work, either as a paid worker, unpaid homemaker, or student, (2) social and leisure activities, (3) relationships with extended family, (4) role as a marital partner, (5) parental role, and (6) role within the family unit, including perceptions about economic functioning.Each question is rated on a five-point scale from which role area means and an overall mean can be obtained, with higher scores denoting greater impairment. Role areas not relevant to the respondent can be skipped. Overall means are based on all items completed by the respondent. Scores range from 0 = no difficulties to 125 = broad difficulties in multiple domains. An overall adjustment |
| Secondary | Change in Brief Pain Inventory Score - Intensity | Timepoints will be at baseline, and post-infusion 1hr, and days 1, 3, 7, 14, & 28. | Self report inventory that assesses intensity of pain and its interference with everyday life. Intensity: pain severity as measured by a 0 to 10 visual analogue scale. 0 = no pain, 10 = worst pain imaginable. Interference score: Interference as measured by a 0 to 10 numerical rating scale. 0 = does not interfere, 10 = completely interferes |
| Secondary | Change in Brief Pain Inventory Score - Interference | Timepoints will be at baseline, and post-infusion 1hr, and days 1, 3, 7, 14, & 28. | Self report inventory that assesses intensity of pain and its interference with everyday life. Intensity: pain severity as measured by a 0 to 10 visual analogue scale. 0 = no pain, 10 = worst pain imaginable. Interference score: Interference as measured by a 0 to 10 numerical rating scale. 0 = does not interfere, 10 = completely interferes |
| Secondary | Change in Clinician-Administered Dissociative States Scale (CADSS) Score | Timepoints: pre- infusion, during infusion +20, +40 minutes, and post-infusion 40 minutes. | This scale captures the range of possible subjective side effects of ketamine or Midazolam. This consists of 23 questions and scores for each question range from 0-4. The maximum score is 92 with higher scores indicating more dissociative symptoms. |
| Secondary | Change in Adverse Events | Timepoints: Continuous monitoring throughout infusion; post-infusion days 1, 3, 7, 14, 28. | Adverse events were tracked in a log of treatment emergent adverse events, EKG, pulse oximetry, vital signs. A count of any treatment emergent adverse events is presented through Day 28. The outcome measure description as updated when results were entered. |
| Secondary | Change in 'Reading the Mind in the Eyes' Test (RMET) Score | Timepoints: at baseline and 3, 7, 14, 28 days after infusion. | The RMET is an advanced test of theory of mind. It is widely used to assess individual differences in social cognition and emotion recognition across different groups and cultures. This is a score from 0-36 where higher score indicates better performance. |
| Secondary | Change in Brief Psychiatric Rating Scale (BPRS) Total Scores | Timepoints: pre-infusion, during infusion +20, +40 minutes, post-infusion +40 minutes | BPRS is an 18-item clinician rated scale with 11 general symptom items, 5 positive-symptom items, and 2 negative symptom items scored on a 7-point scale (1=not present and 7=extremely severe), with higher score indicating greater severity of symptom. Total possible score range=18 to 126. |
| Secondary | Change in Beck Suicide Scale Total Score | Timepoints will be baseline, 1hr post-infusion and at 1, 3, 7, 14, & 28 days after infusion. | The Beck Suicide Scale is a 23 item self report scale with items to specifically assess the presence and intensity of thoughts and actions related to suicidality. Each item response is on a 3 point likert (0-2) for each of 21 items, so possible totals range from 0-42. Higher scores indicate higher suicidality. The description was updated when results were entered. |
| Other | Change 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. | The Implicit Association Test measures implicit automatic associations by tracking the speed at which participants associate different groups of words. The scale is delivered electronically using an open-source software. Three distinct IATs will be administered to assess participant's implicit associations with death, escape, and self harm imagery respectively. |
| Other | Change in Resting State Electroencephalography (EEG) | Timepoints: at baseline and 1 and/or 7 days after infusion. | measurement of electrical patterns in the brain while subject is at rest with eyes open looking at fixation cross |
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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