Back to results

Study of Depression-Ketamine-Brain Function

Primary Purpose

Major Depression

Status

Terminated

Phase

Phase 2

Locations

Switzerland

Study Type

Interventional

Intervention

Ketamine

About this trial

This is an interventional treatment trial for Major Depression focused on measuring depression, ketamine, fMRI

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Men and women aged 18 to 65 years with a diagnosis of major depressive disorder without psychotic features.
Drug-resistant depressed patients (defined as non-response to two sufficiently long (at least 6 weeks) drug trials at the maximal authorized or tolerated dose)
Score 25 or higher on the Montgomery-Asberg Depression Rating Scale
Stable psychotropic medication (antidepressants, antipsychotics, mood stabilizers) during the last 6 weeks prior to inclusion.
Legally competent subjects agreeing to comply with the requirements of the study and authorizing the transmission of relevant information to competent physicians in the case of a clinically relevant previously unknown finding during an MRI examination.

Exclusion Criteria:

Subjects with co-morbid substance abuse or dependence during the 3 months prior to inclusion, except nicotine consumption.
Patients judged to be at serious suicide risk (score ≥ 4 at item 10 of the MADRS).
Patients with any other DSM-IV axis one diagnosis including bipolar disorder except for anxiety disorder which are not dominating the clinical presentation.
History of antidepressant or substance-induced hypomania or mania.
History of psychotic symptoms.
Patients with any contra-indication to the administration of ketamine, especially present diagnosis or antecedents of clinically relevant cardiovascular disorders (clinically significant or not adequately treated hypertension, present or previous diagnosis of cardiovascular disorder such as stroke or heart attack etc).
Any MRI contraindication, especially metallic implants, pacemaker, etc.
Pregnant women, breast-feeding women, women of childbearing age without effective means of contraception.
Treatment during the last 2 weeks with thyroid hormones and sympathicomimetic drug.
Present or past diagnosis of eclampsia or preeclampsia.
Untreated or insufficiently treated hyperthyroidism.
Known hypersensitivity to ketamine or to the excipient (benzethonium chloride).
Present or past diagnosis of glaucoma, intracranial hypertension.

Sites / Locations

Service de Psychiatrie Adulte, Programme dépression

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

ketamine 0.5 mg/kg i.v.

Arm Description

Single administration of ketamine 0.5 mg/kg i.v.

Outcomes

Primary Outcome Measures

Difference of the MADRS score at baseline and after ketamine injection

Secondary Outcome Measures

Full Information

NCT ID

NCT01135758

First Posted

June 2, 2010

Last Updated

December 4, 2015

Sponsor

Markus KOSEL

1. Study Identification

Unique Protocol Identification Number

NCT01135758

Brief Title

Study of Depression-Ketamine-Brain Function

Official Title

Pilot Study Probing the Antidepressant Effects of 0.5 mg/kg Intravenous Ketamine in Drug-resistant Depressed Patients (Unipolar Depression): Efficacy, Safety, Brain Function

Study Type

Interventional

2. Study Status

Record Verification Date

December 2015

Overall Recruitment Status

Terminated

Why Stopped

End of funding of study

Study Start Date

June 2010 (undefined)

Primary Completion Date

June 2015 (Actual)

Study Completion Date

September 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Markus KOSEL

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

Targeting the glutamatergic system to treat depression is a new and promising strategy based on studies at the molecular, synaptic, and neuronal level but also on results of studies conducted in animal models and first clinical studies involving depressed patients.Ketamine has been proposed as a novel approach to induce rapid antidepressant response. In this pilot project the investigators aim to introduce this novel and promising approach into clinical practice. Besides the assessment of clinical efficacy, the investigators will put a special emphasis on the assessment of ketamine-associated effects on brain function using fMRI and cognitive testing.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Major Depression

Keywords

depression, ketamine, fMRI

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

10 (Actual)

8. Arms, Groups, and Interventions

Arm Title

ketamine 0.5 mg/kg i.v.

Arm Type

Experimental

Arm Description

Single administration of ketamine 0.5 mg/kg i.v.

Intervention Type

Drug

Intervention Name(s)

Ketamine

Intervention Description

Administration of a subanaesthetic dose of Ketamine, intravenously (0.5 mg/kg)

Primary Outcome Measure Information:

Title

Difference of the MADRS score at baseline and after ketamine injection

Time Frame

40, 80, 110, 230 min, 1, 2, 3, 6, 7, 10 d after ketamine administration

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Men and women aged 18 to 65 years with a diagnosis of major depressive disorder without psychotic features. Drug-resistant depressed patients (defined as non-response to two sufficiently long (at least 6 weeks) drug trials at the maximal authorized or tolerated dose) Score 25 or higher on the Montgomery-Asberg Depression Rating Scale Stable psychotropic medication (antidepressants, antipsychotics, mood stabilizers) during the last 6 weeks prior to inclusion. Legally competent subjects agreeing to comply with the requirements of the study and authorizing the transmission of relevant information to competent physicians in the case of a clinically relevant previously unknown finding during an MRI examination. Exclusion Criteria: Subjects with co-morbid substance abuse or dependence during the 3 months prior to inclusion, except nicotine consumption. Patients judged to be at serious suicide risk (score ≥ 4 at item 10 of the MADRS). Patients with any other DSM-IV axis one diagnosis including bipolar disorder except for anxiety disorder which are not dominating the clinical presentation. History of antidepressant or substance-induced hypomania or mania. History of psychotic symptoms. Patients with any contra-indication to the administration of ketamine, especially present diagnosis or antecedents of clinically relevant cardiovascular disorders (clinically significant or not adequately treated hypertension, present or previous diagnosis of cardiovascular disorder such as stroke or heart attack etc). Any MRI contraindication, especially metallic implants, pacemaker, etc. Pregnant women, breast-feeding women, women of childbearing age without effective means of contraception. Treatment during the last 2 weeks with thyroid hormones and sympathicomimetic drug. Present or past diagnosis of eclampsia or preeclampsia. Untreated or insufficiently treated hyperthyroidism. Known hypersensitivity to ketamine or to the excipient (benzethonium chloride). Present or past diagnosis of glaucoma, intracranial hypertension.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Markus Kosel, MD-PhD

Organizational Affiliation

Departement of Adult Psychiatry, University Hospital of Geneva

Official's Role

Principal Investigator

Facility Information:

Facility Name

Service de Psychiatrie Adulte, Programme dépression

City

Geneva

ZIP/Postal Code

1207

Country

Switzerland

12. IPD Sharing Statement

Learn more about this trial

Study of Depression-Ketamine-Brain Function

We'll reach out to this number within 24 hrs