A study to see if the medication Ketamine can relieve depression in people who have not responded to another class of medication called Selective Serotonin Re-uptake Inhibitors (SSRIs)

A Preliminary Study of Intravenous Ketamine in Selective Serotonin Reuptake Inhibitor (SSRI)-Resistant Depression

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2011-003654-40-IE

Enrollment

Registered

2011-08-08

Start date

2011-10-21

Completion date

Unknown

Last updated

2022-04-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Depression MedDRA version: 14.0 Level: PT Classification code 10012378 Term: Depression System Organ Class: 10037175 - Psychiatric disorders

Interventions

Trade Name: ketalar Pharmaceutical Form: Solution for injection/infusion INN or Proposed INN: KETAMINE HYDROCHLORIDE CAS Number: 1867-66-9 Current Sponsor code: not applicable Other descriptive name:

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: •Be able to give written informed consent, •Be between the ages of 18 and 65 years of age, male or female •DSM-IV major depression with a Hamilton depression score greater than 17 •Failed trial of an SSRI antidepressant at an adequate dose for at least 6 weeks duration Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 20 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: •Are less than 18 and greater than 65 years of age, •Have a significant acute or chronic coexisting illness [cardiovascular, gastrointestinal, immunological, or any condition which contraindicates, in the investigators judgement, entry to the study]. •Having a condition or taking a medication that the investigator believes would interfere with the objectives of the study, pose a safety risk or confound the interpretation of the study results; to include, anti-inflammatory medications to include aspirin and steroids. •Have evidence of immunodeficiency; bleeding disorder or coagulopathy. •Pregnancy •Family or Personal history of psychosis

Design outcomes

Secondary

Measure	Time frame
Secondary end point(s): When biomarkers i.e. cytokines, tryptophan metabolism markers and endocrine parameters have been measured pre and post ketamine treatment for the 20 patients;Timepoint(s) of evaluation of this end point: one year	—

Primary

Measure	Time frame
Main Objective: To evaluate if IV ketamine treatment given weekly over 3 weeks relieves depressive symptoms in patients who have not responded to SSRI (Selective Serotoninn Reuptake Inhibitors) Antidepressants. ;Secondary Objective: To evaluate biomarkers such as cytokines, tryptophan metabolism and endocrine parameters pre and post ketamine treatment;Primary end point(s): When 20 patients with SSRI- (Antidepressant) resistant Depression have completed 3 sessions of weekly IV Ketamine and have been evaluated 2 weeks post-last ketamine infusion. ;Timepoint(s) of evaluation of this end point: 2 weeks following last ketamine infusion for last of 20 patients	—

Measure

Time frame

Main Objective: To evaluate if IV ketamine treatment given weekly over 3 weeks relieves depressive symptoms in patients who have not responded to SSRI (Selective Serotoninn Reuptake Inhibitors) Antidepressants. ;Secondary Objective: To evaluate biomarkers such as cytokines, tryptophan metabolism and endocrine parameters pre and post ketamine treatment;Primary end point(s): When 20 patients with SSRI- (Antidepressant) resistant Depression have completed 3 sessions of weekly IV Ketamine and have been evaluated 2 weeks post-last ketamine infusion. ;Timepoint(s) of evaluation of this end point: 2 weeks following last ketamine infusion for last of 20 patients

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Countries

Ireland

Contacts

Public ContactKetamine Trial Information

Department of Psychiatry

m.naughton@ucc.ie003532149012201759

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026