A Randomized, Double-Blind, Placebo-Controlled, 2-Period, 2- Treatment Cross-Over Study to Evaluate the Effects of Ketamine on Resting State Functional Brain Connectivity in Major Depressive Disorder Patients who fail to respond to a Selective Serotonin Reuptake Inhibitor (SSRI) or Serotonin Noradrenaline Reuptake Inhibitor (SNRI)
- Conditions
- depressionMajor depressive disorder10027946
- Registration Number
- NL-OMON43144
- Lead Sponsor
- Sumitomo Dainippon Pharma
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 16
Eligible subjects must meet all of the following inclusion criteria at screening:
- Men or women, 18 to 65 years of age, inclusive.
- Meet the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision (DSM-IV-TR) diagnostic criteria for depression, without psychotic features based upon clinical assessment at screening and confirmed by the Mini-International Neuropsychiatric Interview (MINI). Comorbid anxiety disorders with the exception of Post-Traumatic Stress Disorder (PTSD) are allowed, provided these are not the primary psychiatric diagnosis.
- Confirmation of the psychiatric diagnosis by the attending general practitioner and/or psychiatrist.
- Be medically stable on the basis of physical examination, 12-lead ECG, and vital signs, performed at Screening. If there are abnormalities, they must be consistent with the underlying illness in the study population.
- Be medically stable on the basis of clinical laboratory tests performed at screening.
- Has a Hamilton questionnaire score of * 18, at screening and randomization
- Partial or no response to a first trial with a SSRI or SNRI despite a therapeutic dose for at least 4 weeks of treatment.
- Current DSM-IV-TR diagnosis made by attending GP or psychiatrist, or established with the MINI of a comorbid psychotic disorder or MDD with psychotic features, bipolar or related disorders, obsessive compulsive disorder, intellectual disability, borderline personality disorder, antisocial personality disorder, histrionic personality disorder or narcissistic personality disorder
- Patient has a history of drug or alcohol abuse or dependence according to DSM-IV criteria, except nicotine or caffeine, within 6 months before Screening.
- Has been involuntarily committed to psychiatric hospital (current episode)
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method