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Evaluation of Ketamine Hydrochloride's Effect in Obsessive-Compulsive Disorde

Phase 3
Conditions
Obsessive Compulsive Disorder.
Obsessive-compulsive disorder
Registration Number
IRCT20140120016280N5
Lead Sponsor
Tehran University of Medical Sciences
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Pending
Sex
All
Target Recruitment
60
Inclusion Criteria

Definitive diagnosis of obsessive-compulsive disorder based on the psychiatrist assessment and its confirmation according to SCID-5 (Structured-Clinical Interview for DSM5) by the clinical psychologist.
Y-BOCS Score equal or more than 25 for obsessions and compulsions
Lack of sufficient response to one period of standard treatment with enough dose and duration (less than 25 percent reduction in symptom severity)
Being in the age range of 18-40
IQ level more than 80
Signing written informed consent

Exclusion Criteria

Subjects with major depressive disorder, bipolar disorder, personality disorder, and schizophrenia in a way that questions the diagnose of obsessive-compulsive disorder.
Pregnancy, lactation or the imminent possibility of either of these cases or use of birth control methods for female subjects (these items will be assessed by the validated urine tests)
Past or current substance/alcohol abuse or dependence
Past history or current existence of neurological diseases (seizures, epilepsy syndromes, history of trauma, stroke, loss of consciousness) and other severe internal and surgical disorders
Presence of any contraindication to MRI scanning, including metal implants or claustrophobia. Metal implants, pacemaker, other metal (e.g. shrapnel or surgical prostheses) or paramagnetic objects contained within the body which may present a risk to the subject or interfere with the MR scan, as determined in consultation with a neuroradiologist and according to the guidelines set forth in the following reference book commonly used by the neuroradiologists:Guide to MR procedures and metallic objects, F. G.

Study & Design

Study Type
interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Symptom (Obsession and Compulsions) Severity Based on Yale Brown Obsessive Compulsive Disorder Scale. Timepoint: Assessment of Severity and pattern of symptoms : at the beginning of study and before the beginning of intervention, 3 days after intervention and then 10 days after intervention. Method of measurement: Validated Yale Brown Obsessive Compulsive Disorder Scale.
Secondary Outcome Measures
NameTimeMethod
Functional organization of Large-Scale Brain Networks. Timepoint: 72 hours before intervention, and then 72 hours after intervention and 10 days after intervention. Method of measurement: Functional Magnetic Resonance Imaging.
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