Intramuscular Ketamine Versus Aripiprazole and Escitalopram in the Treatment of Resistant Depression
NCT04234776, Phase 4, Unknown, University of Sao Paulo
Trial 10
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
| Field | Value | Source |
|---|---|---|
| Title | Intramuscular Ketamine Versus Aripiprazole and Escitalopram in the Treatment of Resistant Depression | ClinicalTrials.gov |
| NCT number | NCT04234776 | ClinicalTrials.gov |
| Status | Unknown | ClinicalTrials.gov |
| Phases | Phase 4 | ClinicalTrials.gov |
| Enrollment | 88 participants, estimated | ClinicalTrials.gov |
| Lead sponsor | University of Sao Paulo | ClinicalTrials.gov |
| Conditions | Depressive Disorder | ClinicalTrials.gov |
| Interventions | Ketamine, Cognition, Suicide risk, Depression thoughts, Quality of life and disability, Clinical and epidemiological factors, Safety of ketamine IM, Tolerability of ketamine IM | ClinicalTrials.gov |
| First posted | 2020-01-21 | ClinicalTrials.gov |
| Last updated | 2020-01-21 | ClinicalTrials.gov |
Registered outcomes 49
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description | Source |
|---|---|---|---|---|
| Primary | Change in depressive symptoms | 3 times a week in once month (Phase II) | Montomery-Åsberg Depression Rating Scale (\[0-60\] higher scores: worse outcome). No improvement: MADRS ≤ 25% Partial response: MADRS ≥ 25% and \< 50% Response: MADRS ≥ 50% Remission: MADRS ≤10 | ClinicalTrials.gov |
| Primary | Change in depressive symptoms | Once a week in six months (Phase III) | Montgomery-Åsberg Depression Rating Scale (\[0-60\] higher scores: worse outcome). Recovery: Maintenance ≥ 6-8 months Relapse: Full return of symptoms once remission has occurred or worsening ≤ 75% with lower percentage of improvement (HAM-D inclusion criteria) | ClinicalTrials.gov |
| Primary | Change in depressive symptoms | Once a week in once month (Phase IV) | Montgomery-Åsberg Depression Rating Scale (\[0-60\] higher scores: worse outcome). Relapse: Full return of symptoms once remission has occurred or worsening ≤ 75% with lower percentage of improvement (HAM-D inclusion criteria). | ClinicalTrials.gov |
| Secondary | Depression symptoms | Through study completion, an average of 1 year. | Hamiltom Depression Ratins Scale (HAM-D \[0-50\] higher scores: worse outcome). | ClinicalTrials.gov |
| Secondary | Clinical impressions-S | Through study completion, an average of 1 year. | Clinical Global Impression Scale (CGI \[0-7\] higher scores: worse outcome). | ClinicalTrials.gov |
| Secondary | Clinical impressions-I | Through study completion, an average of 1 year. | Clinical Global Impression Scale (CGI \[0-7\] higher scores: worse outcome). | ClinicalTrials.gov |
| Secondary | Electrocardiographic monitoring | 3 times a week in once month (Fase II) and once a week in six months (Phase III) | P wave, PR interval, QRS complex, J-point, ST segment, T wave, Corrected QT interval and U wave Rhythm (irregular rhythm: worse outcome). | ClinicalTrials.gov |
| Secondary | Blood Pressure (BP [mmHg]). | 3 times a week in once month (Fase II) and once a week in six months (Phase III) | BP low \<90/60 (systolic/diastolic) mmHg and high \>140/90 mmHg ( (systolic/diastolic). | ClinicalTrials.gov |
| Secondary | Heart rate (HR [bpm]). | 3 times a week in once month (Fase II) and once a week in six months (Phase III) | Anormal HR \<60 bpm or \>100 bpm. | ClinicalTrials.gov |
| Secondary | Digital pulse oximetry (%). | 3 times a week in once month (Fase II) and once a week in six months (Phase III) | Low oxygen saturation \<95%. | ClinicalTrials.gov |
| Secondary | Respiratory rate (RR [cycles/min]) | 3 times a week in once month (Fase II) and once a week in six months (Phase III) | Anormal RR \<10 cycles/min or \>20 cycles/min. | ClinicalTrials.gov |
| Secondary | Suicide risk 1 | Through study completion, an average of 1 year. | Montgomery-Åsberg Depression Rating Scale (item 10 \[0-6\] higher scores: worse outcome). | ClinicalTrials.gov |
| Secondary | Suicide risk 2 | Through study completion, an average of 1 year. | Hamilton Depression Rating Scale (item 3 \[0-4\] higher scores: worse outcome). | ClinicalTrials.gov |
| Secondary | General side effects | 3 times a week in once month (Phase II) and once a week in six months (Phase III) | Ugvalg for Kliniske Undersgelser-Side Effect Rating Scale (UKU-SERS \[48 specific symptoms). | ClinicalTrials.gov |
| Secondary | Hypo/maniac symptoms | 3 times a week in once month (Phase II) and once a week in six months (Phase III) | Young Mania Rating Scale (YOUNG \[0-58\] higher scores: worse outcome). | ClinicalTrials.gov |
| Secondary | Dissociative symptoms | 3 times a week in once month (Phase II) and once a week in six months (Phase III) | Clinician-Administered Dissociative State Scale (CADSS \[0-108\] higher scores: worse outcome) | ClinicalTrials.gov |
| Secondary | Psychotic symptoms | 3 times a week in once month (Phase II) and once a week in six months (Phase III) | Brief Psychiatric Rating Scale (item 12 \[0-6\] higher scores: worse outcome). | ClinicalTrials.gov |
| Secondary | Depression thoughts | Through study completion, an average of 1 year. | Depression Thoughts Scale (EPD \[1-78\] higher scores: worse outcome) | ClinicalTrials.gov |
| Secondary | Stimate intelligence quocient | Through study completion, an average of 1 year. | Wechsler Abreviated Scale of Intelligence (WASI \[70-160 percentille\] higher scores: better outcomes). | ClinicalTrials.gov |
| Secondary | Intelligence quocient | Through study completion, an average of 1 year. | Wechsler Scale of Intelligence (WAIS III \[70-155 percentille\] higher scores: better outcomes). | ClinicalTrials.gov |
Outcomes 0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as | Source |
|---|
Results by group 0
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units | Source |
|---|
Participant flow 0
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted | Source |
|---|
Adverse events 0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events | Source |
|---|
Adverse event totals 0
The totals the trial posted for each group.
| Total | Group | Affected | At risk | Source |
|---|
Papers 47
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as | Source |
|---|---|---|
| 1308374 | RESULT | PubMed |
| 2650898 | RESULT | PubMed |
| 9928972 | RESULT | PubMed |
| 10686270 | RESULT | PubMed |
| 15800181 | RESULT | PubMed |
| 17074942 | RESULT | PubMed |
| 18425072 | RESULT | PubMed |
| 19897179 | RESULT | PubMed |
| 20151847 | RESULT | PubMed |
| 21292242 | RESULT | PubMed |
| 21827775 | RESULT | PubMed |
| 21907221 | RESULT | PubMed |
| 22516044 | RESULT | PubMed |
| 22840761 | RESULT | PubMed |
| 23295207 | RESULT | PubMed |
| 23380715 | RESULT | PubMed |
| 23429808 | RESULT | PubMed |
| 23554581 | RESULT | PubMed |
| 23732839 | RESULT | PubMed |
| 23866089 | RESULT | PubMed |
Grants 0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years | Source |
|---|
Trial comparisons 0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|
Tests 3
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
| Test | Named as | Source |
|---|---|---|
| Stroop Color-Word Test | Secondary outcome | ConductCognition |
| Verbal Fluency | Secondary outcome | ConductCognition |
| Verbal Learning | Secondary outcome | ConductCognition |
Source 5
| Field | Value | Source |
|---|---|---|
| Release | trials-2026-11-12-0.4.0 | ClinicalTrials.gov |
| Release manifest SHA-256 | 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4 | ClinicalTrials.gov |
| Registry capture | 2026-11-12 | ClinicalTrials.gov |
| Results copy, AACT | 2026-03-23 | ClinicalTrials.gov |
| NIH clinical studies file | 2026-11-13 | ClinicalTrials.gov |
Release trials-2026-11-12-0.4.0
ClinicalTrials.gov's posted results, through CTTI's AACT: ClinicalTrials.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.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
ClinicalTrials.gov: none stated ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
NIH RePORTER's clinical studies and project files: Public domain (NIH RePORTER)