Trial Outcomes & Findings for Ketamine Plus Lithium in Treatment-Resistant Depression (NCT NCT01880593)

NCT ID: NCT01880593

Last Updated: 2018-07-31

Results Overview

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).

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

34 participants

Primary outcome timeframe

2 weeks after last ketamine infusion

Results posted on

2018-07-31

Participant Flow

Recruitment from May 2013 through Sept 2016

Participant milestones

Participant milestones
Measure	Ketamine and Lithium 600-1200mg of Lithium pills at night for duration of the study	Ketamine and Placebo Placebo pills at night for duration of the study
Overall Study STARTED	18	16
Overall Study COMPLETED	10	10
Overall Study NOT COMPLETED	8	6

Reasons for withdrawal

Reasons for withdrawal
Measure	Ketamine and Lithium 600-1200mg of Lithium pills at night for duration of the study	Ketamine and Placebo Placebo pills at night for duration of the study
Overall Study Adverse Event	1	0
Overall Study Lack of Efficacy	1	5
Overall Study Withdrawal by Subject	6	1

Baseline Characteristics

Ketamine Plus Lithium in Treatment-Resistant Depression

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Ketamine and Lithium n=18 Participants 600-1200mg of Lithium pills at night for duration of the study	Ketamine and Placebo n=16 Participants Placebo pills at night for duration of the study	Total n=34 Participants Total of all reporting groups
Age, Continuous	45 years STANDARD_DEVIATION 12.65 • n=5 Participants	45.87 years STANDARD_DEVIATION 10.94 • n=7 Participants	45.41 years STANDARD_DEVIATION 11.70 • n=5 Participants
Sex: Female, Male Female	9 Participants n=5 Participants	9 Participants n=7 Participants	18 Participants n=5 Participants
Sex: Female, Male Male	9 Participants n=5 Participants	7 Participants n=7 Participants	16 Participants n=5 Participants
MADRS	32.39 units on a scale STANDARD_DEVIATION 3.87 • n=5 Participants	32.81 units on a scale STANDARD_DEVIATION 5.61 • n=7 Participants	32.58 units on a scale STANDARD_DEVIATION 4.69 • n=5 Participants
QIDS	16.22 units on a scale STANDARD_DEVIATION 4.33 • n=5 Participants	18.19 units on a scale STANDARD_DEVIATION 3.082 • n=7 Participants	17.16 units on a scale STANDARD_DEVIATION 4.32 • n=5 Participants
CGI-S	4.66 units on a scale STANDARD_DEVIATION .59 • n=5 Participants	5 units on a scale STANDARD_DEVIATION .52 • n=7 Participants	4.92 units on a scale STANDARD_DEVIATION .57 • n=5 Participants
BSS	5.89 units on a scale STANDARD_DEVIATION 7.71 • n=5 Participants	7.56 units on a scale STANDARD_DEVIATION 8.31 • n=7 Participants	7.24 units on a scale STANDARD_DEVIATION 8.10 • n=5 Participants
HAM-A	18.78 units on a scale STANDARD_DEVIATION 7.02 • n=5 Participants	20.31 units on a scale STANDARD_DEVIATION 5.11 • n=7 Participants	19.5 units on a scale STANDARD_DEVIATION 6.15 • n=5 Participants
CSSRS (lifetime)	2.5 units on a scale STANDARD_DEVIATION 2.7 • n=5 Participants	2.06 units on a scale STANDARD_DEVIATION 2.02 • n=7 Participants	2.29 units on a scale STANDARD_DEVIATION 2.28 • n=5 Participants

PRIMARY outcome

Timeframe: 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).

Outcome measures

Outcome measures
Measure	Ketamine and Lithium n=18 Participants 600-1200mg of Lithium pills at night for duration of the study	Ketamine and Placebo n=16 Participants Placebo pills at night for duration of the study
MADRS-S Score	22.56 units on a scale Standard Deviation 11.22	23 units on a scale Standard Deviation 12.6

SECONDARY outcome

Timeframe: 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).

Outcome measures

Outcome measures
Measure	Ketamine and Lithium n=18 Participants 600-1200mg of Lithium pills at night for duration of the study	Ketamine and Placebo n=16 Participants Placebo pills at night for duration of the study
QIDS-SR Score	9.89 units on a scale Standard Deviation 6.04	10.13 units on a scale Standard Deviation 6.47

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Ketamine and Lithium n=18 Participants 600-1200mg of Lithium pills at night for duration of the study	Ketamine and Placebo n=16 Participants Placebo pills at night for duration of the study
CGI-S Score	3.83 units on a scale Standard Deviation .86	3.875 units on a scale Standard Deviation 1.36

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Ketamine and Lithium n=18 Participants 600-1200mg of Lithium pills at night for duration of the study	Ketamine and Placebo n=16 Participants Placebo pills at night for duration of the study
HAM-A Score	13.5 units on a scale Standard Deviation 8.15	11.13 units on a scale Standard Deviation 6.08

SECONDARY outcome

Timeframe: 2 weeks after last ketamine infusion

BECK Scale for Suicidal Ideation (BSS) - 0-13 Minimal; 14-19 Mild; 20-28 Moderate; 29-63 Severe

Outcome measures

Outcome measures
Measure	Ketamine and Lithium n=18 Participants 600-1200mg of Lithium pills at night for duration of the study	Ketamine and Placebo n=16 Participants Placebo pills at night for duration of the study
BSS Score	4.94 units on a scale Standard Deviation 7.35	2.69 units on a scale Standard Deviation 5.95

SECONDARY outcome

Timeframe: 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).

Outcome measures

Outcome measures
Measure	Ketamine and Lithium n=18 Participants 600-1200mg of Lithium pills at night for duration of the study	Ketamine and Placebo n=16 Participants Placebo pills at night for duration of the study
CSSRS Score	.833 units on a scale Standard Deviation 2.12	.44 units on a scale Standard Deviation .89

SECONDARY outcome

Timeframe: 2 weeks after last ketamine infusion

Number of Participants with PRISE

Outcome measures

Outcome measures
Measure	Ketamine and Lithium n=18 Participants 600-1200mg of Lithium pills at night for duration of the study	Ketamine and Placebo n=16 Participants Placebo pills at night for duration of the study
Patient Rated Inventory of Side Effects (PRISE)	3 Participants	2 Participants

Adverse Events

Ketamine and Lithium

Serious events: 0 serious events

Other events: 15 other events

Deaths: 0 deaths

Ketamine and Placebo

Serious events: 0 serious events

Other events: 12 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Ketamine and Lithium n=18 participants at risk 600-1200mg of Lithium pills at night for duration of the study	Ketamine and Placebo n=16 participants at risk Placebo pills at night for duration of the study
Gastrointestinal disorders Nausea	44.4% 8/18	25.0% 4/16
Gastrointestinal disorders Dry Mouth	16.7% 3/18	0.00% 0/16
Gastrointestinal disorders Diarrhea	50.0% 9/18	12.5% 2/16
Gastrointestinal disorders Constipation	16.7% 3/18	0.00% 0/16
Gastrointestinal disorders Vomiting	11.1% 2/18	0.00% 0/16
Gastrointestinal disorders Abdominal Pain	16.7% 3/18	0.00% 0/16
Nervous system disorders Headache	44.4% 8/18	56.2% 9/16
Nervous system disorders Dizziness	11.1% 2/18	0.00% 0/16
Nervous system disorders Tinnitus	11.1% 2/18	0.00% 0/16
Nervous system disorders Tremor	11.1% 2/18	0.00% 0/16
Musculoskeletal and connective tissue disorders Arthralgia	11.1% 2/18	0.00% 0/16
General disorders Fatigue	11.1% 2/18	0.00% 0/16
General disorders Chest Discomfort	0.00% 0/18	12.5% 2/16
Renal and urinary disorders Pollakiuria	16.7% 3/18	6.2% 1/16
Renal and urinary disorders Polyuria	11.1% 2/18	0.00% 0/16
Psychiatric disorders Insomnia	11.1% 2/18	6.2% 1/16
Psychiatric disorders Anxiety	0.00% 0/18	12.5% 2/16
Skin and subcutaneous tissue disorders Rash	16.7% 3/18	0.00% 0/16

Additional Information

Dr. James Murrough

Icahn School of Medicine at Mount Sinai

Phone: 212-241-7574

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place