A Naturalistic Study of Ketamine for Treatment Resistant Mood Disorders

NCT04226963 | Completed

• 1 other identifier: NKBBN/172-674/2019
• Study Type: observational
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

This study aims to openly test the long-term safety, tolerability and effectiveness of repeated administration of IV, nasal spray and oral ketamine for treatment-resistant mood disorders.

Conditions

Treatment Resistant Depression; Bipolar Depression; Ketamine; Major Depressive Disorder

Keywords

treatment resistant depression; bipolar depression; ketamine; multiple series; major depressive disorder

Outcome Measures

Primary Outcomes (9)

• Incidence of adverse events assessed by Clinical-Administered Dissociative Symptoms Scale (CADSS)

  Incidence of adverse events will be assessed by Clinician-Administered Dissociative Symptoms Scale (change from baseline to each measure). Higher values represent a worse severity, but not necessarily outcome. The Clinical-Administered Dissociative Symptoms Scale has 23-items based on dissociative symptoms during the assessment. Each item is scored 0 (normal) to 4 (severe symptoms) with overall score ranges from 0 (normal) to 92 (severe symptoms). Total number of assessments:18 times

  Baseline through week 5

• Incidence of adverse events assessed by 4-items positive symptoms subscale of Brief Psychiatric Rating Scale (BPRS)

  Incidence of adverse events will be assessed by 4-items positive symptoms subscale of Brief Psychiatric Rating Scale (change from baseline to each measure). Higher values represent a worse severity but not necessarily outcome. The 4-item positive symptoms subscale of Brief Psychiatric Rating Scale has 4-items based on conceptual disorganization, suspiciousness, hallucination and unusual thought content. Each item is scored 0 (normal) to 6 (severe symptoms) with overall score ranges from 0 (normal) to 24 (severe symptoms). Total number of assessments:18 times

  Baseline through week 5

• Incidence of adverse events assessed by body temperature (oral measurements)

  Incidence of adverse events assessed by body temperature (oral measurement) in Celsius degree - change from baseline to each measure. A normal range is from 36.2 to 38.0 Celsius degrees; measurements beyond those ranges are clinically significant. The total number of measurements: 44 times

  Baseline through week 5

• Incidence of adverse events assessed by blood pressure

  Incidence of adverse events assessed by blood pressure (after the participant has rested for at least 5 minutes) in mmHg - change from baseline to each measure. A normal range for systolic blood pressure is from 90 to 140 mmHg, for diastolic blood pressure is from 50 to 90 mmHg; measurements beyond those ranges are clinically significant. The total number of measurements: 44 times

  Baseline through week 5

• Incidence of adverse events assessed by respiration rate

  Incidence of adverse events assessed by respiration rate in a breath number per minute - change from baseline to each measure. A normal range for respiration is from 12 to 16 breaths per minute; measurements beyond those ranges are clinically significant. The total number of measurements: 44 times

  Baseline through week 5

• Incidence of adverse events assessed by pulse

  Incidence of adverse events assessed by pulse (beats per minute \[bpm\]) - change from baseline to each measure. A normal range for pulse is from 60 to 90 bpm; measurements beyond those ranges are clinically significant. The total number of measurements: 44 times

  Baseline through week 5

• Incidence of adverse events assessed by blood oxygen saturation

  Incidence of adverse events assessed by blood oxygen saturation in percentage - change from baseline to each measure. A normal range for blood oxygen saturation is from 95 to 100 percentage; measurements under 95% are clinically significant. The total number of measurements: 44 times

  Baseline through week 5

• Incidence of adverse events assessed by weight

  Incidence of adverse events assessed by weight in kilograms- change from baseline to each measure. Gain weight for 7% baseline weight is clinically significant. Total numbers of assessments: 2. Weight and height will be combined to report BMI in kg/m\^2

  Baseline and week 5

• Incidence of adverse events assessed by height

  Incidence of adverse events assessed by height in meters. Total numbers of assessments: 1. Weight in kilograms and height in meters will be combined to report BMI in kg/m\^2

  Baseline

Secondary Outcomes (1)

• Change in severity of depression symptoms assessed by Montgomery-Asberg Depression Rating Scale (MADRS)

  Baseline through week 5

Interventions

Ketamine DRUG

Ketamine will be infused (slow IV infusions of ketamine (0.5 mg/kg) over 40 minutes) twice weekly over a period of 4 weeks) Ketamine will be given in intranasal spray twice weekly over a period of 4 weeks Ketamine will be given orally (solution 2.0mg/kg, 2.5mg/kg) twice weekly over a period of 4 weeks.

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Inpatients with TRD referred to the tertiary-reference unit for mood disorders

You may qualify if:

• Major depressive disorder (MDD) or bipolar disorder (BD) diagnosis as provided by DSM-5 criteria
• TRD defined as the patient does not reach remission within the 8 week trial of an antidepressant or combination at a therapeutic dose of at least two trials of first-line evidence-based treatments and/or electroconvulsive therapy (ECT)

You may not qualify if:

• Pregnancy and lactation
• Hypersensitivity to ketamine
• Uncontrolled hypertension
• Other uncontrolled somatic diseases that may impact safety per investigators judgement

Sponsors & Collaborators

• Medical University of Gdansk: lead

Study Sites (1)

Department of Psychiatry, Medical University of Gdańsk

Gdansk, 80-952, Poland

Location

Related Publications (3)

• Kachlik Z, Cubala WJ, Walaszek M, Pastuszak M, Pastuszak K, Kwasny A. Nonresponse to Ketamine in Treatment-Resistant Bipolar Depression. Neuropsychopharmacol Rep. 2025 Sep;45(3):e70038. doi: 10.1002/npr2.70038.

  PMID: 40879542 DERIVED

• Wlodarczyk A, Cubala WJ, Galuszko-Wegielnik M, Szarmach J. Dissociative symptoms with intravenous ketamine in treatment-resistant depression exploratory observational study. Medicine (Baltimore). 2021 Jul 23;100(29):e26769. doi: 10.1097/MD.0000000000026769.

  PMID: 34398056 DERIVED

• Wlodarczyk A, Cubala WJ, Galuszko-Wegielnik M, Szarmach J. Central nervous system-related safety and tolerability of add-on ketamine to antidepressant medication in treatment-resistant depression: focus on the unique safety profile of bipolar depression. Ther Adv Psychopharmacol. 2021 May 19;11:20451253211011021. doi: 10.1177/20451253211011021. eCollection 2021.

  PMID: 34046159 DERIVED

MeSH Terms

Conditions

Depressive Disorder, Treatment-Resistant; Bipolar Disorder; Depressive Disorder, Major

Interventions

Ketamine

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders; Bipolar and Related Disorders

Intervention Hierarchy (Ancestors)

Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Week
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator, Clinical doctor

Study Record Dates

• First Submitted: January 2, 2020
• First Posted: January 13, 2020
• Study Start: December 4, 2019
• Primary Completion: July 4, 2022
• Study Completion: July 4, 2022
• Last Updated: September 28, 2023

Record last verified: 2023-09

Locations

PL (1)