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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

Tracking Information
First Submitted Date  ICMJE June 2, 2010
First Posted Date  ICMJE June 3, 2010
Last Update Posted Date December 7, 2015
Study Start Date  ICMJE June 2010
Actual Primary Completion Date June 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 2, 2010)
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 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study of Depression-Ketamine-Brain Function
Official Title  ICMJE Pilot Study Probing the Antidepressant Effects of 0.5 mg/kg Intravenous Ketamine in Drug-resistant Depressed Patients (Unipolar Depression): Efficacy, Safety, Brain Function
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Major Depression
Intervention  ICMJE Drug: Ketamine
Administration of a subanaesthetic dose of Ketamine, intravenously (0.5 mg/kg)
Study Arms  ICMJE Experimental: ketamine 0.5 mg/kg i.v.
Single administration of ketamine 0.5 mg/kg i.v.
Intervention: Drug: Ketamine
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: July 11, 2015)
10
Original Estimated Enrollment  ICMJE
 (submitted: June 2, 2010)
15
Actual Study Completion Date  ICMJE September 2015
Actual Primary Completion Date June 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Switzerland
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01135758
Other Study ID Numbers  ICMJE CE09-144/Psy 09-22
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Markus KOSEL, University Hospital, Geneva
Study Sponsor  ICMJE Markus KOSEL
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Markus Kosel, MD-PhD Departement of Adult Psychiatry, University Hospital of Geneva
PRS Account University Hospital, Geneva
Verification Date December 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP