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Trial · NCT01179009

Treatment Resistant Depression (Pilot)

NCT01179009, Not applicable, Completed, Washington University School of Medicine; results first posted 2023-09-15

3 sourcestrials-2026-11-12-0.5.0

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ConductScience Library. Treatment Resistant Depression (Pilot). Trials, record NCT01179009. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01179009

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title
Treatment Resistant Depression (Pilot)
NCT number
NCT01179009
Status
Completed
Phases
Not applicable
Enrollment
20 participants, actual
Lead sponsor
Washington University School of Medicine
Conditions
Depressive Disorder, Treatment-Resistant
Interventions
Ketamine, Clonidine, placebo
First posted
2010-08-10
Last updated
2023-09-15
Results first posted
2023-09-15
Limitations and caveats
A pilot and feasibility study with limited statistical power due to a small sample size. Another limitation was the lack of a scale specifically measuring dissociative symptoms. In addition, the allowance of co-occurring antidepressant use could result in increased heterogeneity of responses unrelated to the study medication. Finally, the sample was ethnically homogeneous.

Source ClinicalTrials.gov

Registered outcomes2

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

ListOutcomeTime frameDescription
PrimaryMontgomery-Asberg Depression Rating Scale (MADRS) Total Score8 weeks
The Montgomery-Asberg Depression Rating Scale (MADRS) is a 10-item scale that measures the severity of depression, with a higher score indicating a higher level of depression. The range of scores is 0 to 60.
PrimaryClinical Global Impression (CGI) Global Improvement Score.8 weeksThe Clinical Global Improvement is a 7-point scale where the anchors range from 1 (very much improved) to 7 (very much worse).

Source ClinicalTrials.gov

Outcomes2

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

TypeOutcomeTime framePopulationUnitsMeasured as
PRIMARYMontgomery-Asberg Depression Rating Scale (MADRS) Total Score8 weeksScores on a scaleMEAN
PRIMARYClinical Global Impression (CGI) Global Improvement Score.8 weeksParticipantsCOUNT_OF_PARTICIPANTS

Source ClinicalTrials.gov

Results by group16

Each measurement the trial posted, group by group, in the words and numbers it posted.

OutcomeGroupCategoryValueSpreadUnits
Montgomery-Asberg Depression Rating Scale (MADRS) Total ScoreKetamine 100-hour Infusion-9.0Standard Deviation 9.5Scores on a scale
Montgomery-Asberg Depression Rating Scale (MADRS) Total ScoreKetamine 40-minute Infusion-6.4Standard Deviation 8.7Scores on a scale
Clinical Global Impression (CGI) Global Improvement Score.Ketamine 100-hour InfusionVery much improved2Participants
Clinical Global Impression (CGI) Global Improvement Score.Ketamine 40-minute InfusionVery much improved1Participants
Clinical Global Impression (CGI) Global Improvement Score.Ketamine 100-hour InfusionMuch improved2Participants
Clinical Global Impression (CGI) Global Improvement Score.Ketamine 40-minute InfusionMuch improved1Participants
Clinical Global Impression (CGI) Global Improvement Score.Ketamine 100-hour InfusionMinimally improved1Participants
Clinical Global Impression (CGI) Global Improvement Score.Ketamine 40-minute InfusionMinimally improved0Participants
Clinical Global Impression (CGI) Global Improvement Score.Ketamine 100-hour InfusionNo change5Participants
Clinical Global Impression (CGI) Global Improvement Score.Ketamine 40-minute InfusionNo change5Participants

1 to 10 of 16Source ClinicalTrials.gov

See all 16 results by group

Participant flow6

How many started, completed or left each group, period by period.

PeriodMilestoneGroupParticipantsUnits counted
Overall StudySTARTEDKetamine 100-hour Infusion10
Overall StudySTARTEDKetamine 40-minute Infusion10
Overall StudyCOMPLETEDKetamine 100-hour Infusion10
Overall StudyCOMPLETEDKetamine 40-minute Infusion10
Overall StudyNOT COMPLETEDKetamine 100-hour Infusion0
Overall StudyNOT COMPLETEDKetamine 40-minute Infusion0

Source ClinicalTrials.gov

Adverse events38

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

TypeEventOrgan systemGroupAffectedAt riskEvents
otherVisual distortions and hallucinationsGeneral disordersKetamine 100-hour Infusion7107
otherVisual distortions and hallucinationsGeneral disordersKetamine 40-minute Infusion4104
otherUnusual thoughts and delusionsGeneral disordersKetamine 100-hour Infusion7107
otherUnusual thoughts and delusionsGeneral disordersKetamine 40-minute Infusion5105
otherIncoherentGeneral disordersKetamine 100-hour Infusion2102
otherIncoherentGeneral disordersKetamine 40-minute Infusion1101
otherDisorientationGeneral disordersKetamine 100-hour Infusion3103
otherDisorientationGeneral disordersKetamine 40-minute Infusion2102
otherDecreased Concentration/Memory LossGeneral disordersKetamine 100-hour Infusion101010
otherDecreased Concentration/Memory LossGeneral disordersKetamine 40-minute Infusion101010

1 to 10 of 38Source ClinicalTrials.gov

See all 38 adverse events

Adverse event totals6

The totals the trial posted for each group.

TotalGroupAffectedAt risk
Total, all-cause mortalityKetamine 100-hour Infusion010
Total, all-cause mortalityKetamine 40-minute Infusion010
Total, other adverse eventsKetamine 100-hour Infusion1010
Total, other adverse eventsKetamine 40-minute Infusion1010
Total, serious adverse eventsKetamine 100-hour Infusion010
Total, serious adverse eventsKetamine 40-minute Infusion010

Source ClinicalTrials.gov

Papers46

The papers the trial lists on ClinicalTrials.gov.

PMIDListed asSource
444788BACKGROUNDPubMed
2708545BACKGROUNDPubMed
4704758BACKGROUNDPubMed
7576011BACKGROUNDPubMed
7648766BACKGROUNDPubMed
7944874BACKGROUNDPubMed
9447860BACKGROUNDPubMed
9507131BACKGROUNDPubMed
9885791BACKGROUNDPubMed
10686270BACKGROUNDPubMed

1 to 10 of 46

See all 46 papers

Grants0

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.

None in this release.

Trial comparisons2

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

ComparisonSource
Ketamine 100-hour Infusion vs Ketamine 40-minute Infusion: deaths from any causeTrial comparisons
Ketamine 100-hour Infusion vs Ketamine 40-minute Infusion: serious adverse eventsTrial comparisons

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov
2026-11-12
ClinicalTrials.gov
Results, from AACT
2026-03-23
AACT
NIH grant links
2026-11-13
NIH RePORTER

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.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT01179009

GET https://conductscience.org/api/trials/v1/NCT01179009/events?page=2

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