Study of Depression-Ketamine-Brain Function

Major Depression Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01135758
• Other study ID #: CE09-144/Psy 09-22
• Status: Terminated
• Phase: Phase 2
• First received: June 2, 2010
• Last updated: December 4, 2015
• Start date: June 2010
• Est. completion date: September 2015

Study information

• Verified date: December 2015
• Source: University Hospital, Geneva
• Contact: n/a
• Is FDA regulated: No
• Health authority: Switzerland: Swissmedic
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 10
• Est. completion date: September 2015
• Est. primary completion date: June 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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.

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Depressive Disorder, Major
• Major Depression

Intervention

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

Locations

Country	Name	City	State
Switzerland	Service de Psychiatrie Adulte, Programme dépression	Geneva

Sponsors (1)

Lead Sponsor	Collaborator
Markus KOSEL

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Difference of the MADRS score at baseline and after ketamine injection		40, 80, 110, 230 min, 1, 2, 3, 6, 7, 10 d after ketamine administration	No