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Study of Depression-Ketamine-Brain Function

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ClinicalTrials.gov Identifier: NCT01135758
Recruitment Status : Terminated (End of funding of study)
First Posted : June 3, 2010
Last Update Posted : December 7, 2015
Sponsor:
Information provided by (Responsible Party):
Markus KOSEL, University Hospital, Geneva

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.

Condition or disease Intervention/treatment Phase
Major Depression Drug: Ketamine Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 10 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : June 2010
Actual Primary Completion Date : June 2015
Actual Study Completion Date : September 2015

Resource links provided by the National Library of Medicine

Drug Information available for: Ketamine

Arm Intervention/treatment
Experimental: ketamine 0.5 mg/kg i.v.
Single administration of ketamine 0.5 mg/kg i.v.
Drug: Ketamine
Administration of a subanaesthetic dose of Ketamine, intravenously (0.5 mg/kg)




Primary Outcome Measures :
  1. 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 ]


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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01135758


Locations
Switzerland
Service de Psychiatrie Adulte, Programme dépression
Geneva, Switzerland, 1207
Sponsors and Collaborators
Markus KOSEL
Investigators
Principal Investigator: Markus Kosel, MD-PhD Departement of Adult Psychiatry, University Hospital of Geneva

Responsible Party: Markus KOSEL, MD-PhD, University Hospital, Geneva
ClinicalTrials.gov Identifier: NCT01135758     History of Changes
Other Study ID Numbers: CE09-144/Psy 09-22
First Posted: June 3, 2010    Key Record Dates
Last Update Posted: December 7, 2015
Last Verified: December 2015

Keywords provided by Markus KOSEL, University Hospital, Geneva:
depression, ketamine, fMRI

Additional relevant MeSH terms:
Depression
Depressive Disorder
Depressive Disorder, Major
Behavioral Symptoms
Mood Disorders
Mental Disorders
Ketamine
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anesthetics, Dissociative
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
Central Nervous System Depressants
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action