Trial · NCT01880593

Ketamine Plus Lithium in Treatment-Resistant Depression

NCT01880593, Phase 2, Completed, Icahn School of Medicine at Mount Sinai; results first posted 2018-07-31

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Ketamine Plus Lithium in Treatment-Resistant Depression. Trials, record NCT01880593. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01880593

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Trial

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

Title: Ketamine Plus Lithium in Treatment-Resistant Depression
NCT number: NCT01880593
Status: Completed
Phases: Phase 2
Enrollment: 34 participants, actual
Lead sponsor: Icahn School of Medicine at Mount Sinai
Conditions: Depression
Interventions: Lithium, Ketamine, Placebo
First posted: 2013-06-19
Last updated: 2018-07-31
Results first posted: 2018-07-31

Source ClinicalTrials.gov

Registered outcomes7

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

List	Outcome	Time frame	Description
Primary	MADRS-S Score	2 weeks after last ketamine infusion	The Montgomery Asberg Depression Rating Scale (MADRS-S) has 10-items which are based on mood symptoms over the past 7 days. Each items is scored 0 (normal) to 6 (severe depression) with overall score ranges from 0 (normal) to 60 (severe depression).
Secondary	QIDS-SR Score	2 weeks after last ketamine infusion	Quick Inventory of Depressive Symptomatology, Self-Report (QIDS-SR) score - Each item is rated 0 (no depression) to 3 (severe depression), for a total score range of 0 (no depression) to 27 (severe depression).
Secondary	CGI-S Score	2 weeks after last ketamine infusion	The Clinical Global Impression - Severity scale (CGI-S) is a 7-point scale that requires the clinician to rate the severity of the patient's illness at the time of assessment, relative to the clinician's past experience with patients who have the same diagnosis. Considering total clinical experience, a patient is assessed on severity of mental illness at the time of rating 1, normal, not at all ill; 2, borderline mentally ill; 3, mildly ill; 4, moderately ill; 5, markedly ill; 6, severely ill; or 7, extremely ill.
Secondary	HAM-A Score	2 weeks after last ketamine infusion	Each item is scored on a scale of 0 (not present) to 4 (severe), with a total score range of 0-56, where \<17 indicates mild severity, 18-24 mild to moderate severity and 25-30 moderate to severe.
Secondary	BSS Score	2 weeks after last ketamine infusion	BECK Scale for Suicidal Ideation (BSS) - 0-13 Minimal; 14-19 Mild; 20-28 Moderate; 29-63 Severe
Secondary	CSSRS Score	2 weeks after last ketamine infusion	Columbia Suicide Severity Rating Scale (CSSRS) - Full range from 0 (low intensity suicidal ideation to 9 (high intensity suicidal ideation).
Secondary	Patient Rated Inventory of Side Effects (PRISE)	2 weeks after last ketamine infusion	Number of Participants with PRISE

Source ClinicalTrials.gov

Outcomes7

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

Type	Outcome	Time frame	Units	Measured as
PRIMARY	MADRS-S Score	2 weeks after last ketamine infusion	units on a scale	MEAN
SECONDARY	QIDS-SR Score	2 weeks after last ketamine infusion	units on a scale	MEAN
SECONDARY	CGI-S Score	2 weeks after last ketamine infusion	units on a scale	MEAN
SECONDARY	HAM-A Score	2 weeks after last ketamine infusion	units on a scale	MEAN
SECONDARY	BSS Score	2 weeks after last ketamine infusion	units on a scale	MEAN
SECONDARY	CSSRS Score	2 weeks after last ketamine infusion	units on a scale	MEAN
SECONDARY	Patient Rated Inventory of Side Effects (PRISE)	2 weeks after last ketamine infusion	Participants	COUNT_OF_PARTICIPANTS

Source ClinicalTrials.gov

Results by group14

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

Outcome	Group	Value	Spread	Units
MADRS-S Score	Ketamine and Lithium	22.56	Standard Deviation 11.22	units on a scale
MADRS-S Score	Ketamine and Placebo	23	Standard Deviation 12.6	units on a scale
QIDS-SR Score	Ketamine and Lithium	9.89	Standard Deviation 6.04	units on a scale
QIDS-SR Score	Ketamine and Placebo	10.13	Standard Deviation 6.47	units on a scale
CGI-S Score	Ketamine and Lithium	3.83	Standard Deviation .86	units on a scale
CGI-S Score	Ketamine and Placebo	3.875	Standard Deviation 1.36	units on a scale
HAM-A Score	Ketamine and Lithium	13.5	Standard Deviation 8.15	units on a scale
HAM-A Score	Ketamine and Placebo	11.13	Standard Deviation 6.08	units on a scale
BSS Score	Ketamine and Lithium	4.94	Standard Deviation 7.35	units on a scale
BSS Score	Ketamine and Placebo	2.69	Standard Deviation 5.95	units on a scale

1 to 10 of 14Source ClinicalTrials.gov

See all 14 results by group

Participant flow6

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

Period	Milestone	Group	Participants
Overall Study	STARTED	Ketamine and Lithium	18
Overall Study	STARTED	Ketamine and Placebo	16
Overall Study	COMPLETED	Ketamine and Lithium	10
Overall Study	COMPLETED	Ketamine and Placebo	10
Overall Study	NOT COMPLETED	Ketamine and Lithium	8
Overall Study	NOT COMPLETED	Ketamine and Placebo	6

Source ClinicalTrials.gov

Adverse events36

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
other	Nausea	Gastrointestinal disorders	Ketamine and Lithium	8	18
other	Nausea	Gastrointestinal disorders	Ketamine and Placebo	4	16
other	Dry Mouth	Gastrointestinal disorders	Ketamine and Lithium	3	18
other	Dry Mouth	Gastrointestinal disorders	Ketamine and Placebo	0	16
other	Diarrhea	Gastrointestinal disorders	Ketamine and Lithium	9	18
other	Diarrhea	Gastrointestinal disorders	Ketamine and Placebo	2	16
other	Constipation	Gastrointestinal disorders	Ketamine and Lithium	3	18
other	Constipation	Gastrointestinal disorders	Ketamine and Placebo	0	16
other	Vomiting	Gastrointestinal disorders	Ketamine and Lithium	2	18
other	Vomiting	Gastrointestinal disorders	Ketamine and Placebo	0	16

1 to 10 of 36Source ClinicalTrials.gov

See all 36 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Ketamine and Lithium	0	18
Total, all-cause mortality	Ketamine and Placebo	0	16
Total, other adverse events	Ketamine and Lithium	15	18
Total, other adverse events	Ketamine and Placebo	12	16
Total, serious adverse events	Ketamine and Lithium	0	18
Total, serious adverse events	Ketamine and Placebo	0	16

Source ClinicalTrials.gov

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
22840761	BACKGROUND

Source PubMed

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 comparisons3

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

Comparison	Source
Ketamine and Lithium vs Ketamine and Placebo: Patient Rated Inventory of Side Effects (PRISE)	Trial comparisons
Ketamine and Lithium vs Ketamine and Placebo: deaths from any cause	Trial comparisons
Ketamine and Lithium vs Ketamine and Placebo: serious adverse events	Trial 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/NCT01880593

GET https://conductscience.org/api/trials/v1/NCT01880593/events?page=2

API reference For AI assistants