- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01135758
Study of Depression-Ketamine-Brain Function
December 4, 2015 updated by: Markus KOSEL
Pilot Study Probing the Antidepressant Effects of 0.5 mg/kg Intravenous Ketamine in Drug-resistant Depressed Patients (Unipolar Depression): Efficacy, Safety, Brain Function
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.
Study Overview
Study Type
Interventional
Enrollment (Actual)
10
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Geneva, Switzerland, 1207
- Service de Psychiatrie Adulte, Programme dépression
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: ketamine 0.5 mg/kg i.v.
Single administration of ketamine 0.5 mg/kg i.v.
|
Administration of a subanaesthetic dose of Ketamine, intravenously (0.5 mg/kg)
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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
|
40, 80, 110, 230 min, 1, 2, 3, 6, 7, 10 d after ketamine administration
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Markus Kosel, MD-PhD, Departement of Adult Psychiatry, University Hospital of Geneva
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
June 1, 2010
Primary Completion (Actual)
June 1, 2015
Study Completion (Actual)
September 1, 2015
Study Registration Dates
First Submitted
June 2, 2010
First Submitted That Met QC Criteria
June 2, 2010
First Posted (Estimate)
June 3, 2010
Study Record Updates
Last Update Posted (Estimate)
December 7, 2015
Last Update Submitted That Met QC Criteria
December 4, 2015
Last Verified
December 1, 2015
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Behavioral Symptoms
- Mental Disorders
- Mood Disorders
- Depression
- Depressive Disorder
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Central Nervous System Depressants
- Peripheral Nervous System Agents
- Analgesics
- Sensory System Agents
- Anesthetics, Dissociative
- Anesthetics, Intravenous
- Anesthetics, General
- Anesthetics
- Excitatory Amino Acid Antagonists
- Excitatory Amino Acid Agents
- Ketamine
Other Study ID Numbers
- CE09-144/Psy 09-22
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Major Depression
-
Stanford UniversityTerminatedMajor Depressive Disorder | Major Depressive Episode | Major Depressive Disorder, Recurrent | Major Depression Mild | Major Depression Moderate | Major Depression SevereUnited States
-
Hawler Medical UniversityCompleted
-
Centre Hospitalier Universitaire de BesanconH. Lundbeck A/SCompletedResistant Major DepressionFrance
-
First Affiliated Hospital of Zhejiang UniversityRecruiting
-
University of PittsburghCompletedPostpartum Major DepressionUnited States
-
Si TianmeiUnknownMajor Depression DisorderChina
-
The Hong Kong Polytechnic UniversityNot yet recruitingHealthy | Major Depression in Remission
-
AstraZenecaCompletedNon-psychotic Unipolar Major DepressionArgentina
-
Ruijin HospitalTerminatedTreatment Resistant Major Depression DisorderChina
-
Zentrum für Integrative PsychiatrieGerman Research FoundationCompletedCognitive Performance in Major DepressionGermany
Clinical Trials on Ketamine
-
University of Southern CaliforniaNot yet recruiting
-
Grace Lim, MD, MSNational Institute of Mental Health (NIMH)RecruitingPain, Postoperative | Depression, PostpartumUnited States
-
Ullevaal University HospitalUniversity of OsloCompleted
-
Assistance Publique - Hôpitaux de ParisCompletedArthroplasty, Replacement, HipFrance
-
Assiut UniversityCompletedKetamine Causing Adverse Effects in Therapeutic UseEgypt
-
The University of Texas Health Science Center,...TerminatedPost Partum DepressionUnited States
-
Lotus Clinical Research, LLCiX Biopharma Ltd.Completed
-
Antonios LikourezosCompleted
-
Children's Hospital of MichiganCompletedModerate, Deep Sedation