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

Evaluation of Ketamine Hydrochloride’s Effect on Symptom Characteristics and Neuronal Networks Organization in Patients with Obsessive Compulsive Disorder: A Randomized, Double-Blinded, Placebo-Controlled Clinical Trial

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT20140120016280N5
Enrollment
60
Registered
2021-05-18
Start date
2021-07-23
Completion date
Unknown
Last updated
2021-05-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Obsessive Compulsive Disorder. Obsessive-compulsive disorder

Interventions

Intervention 1: Intervention group: This group, which includes subjects diagnosed with obsessive-compulsive disorder, receives injectable ketamine hydrochloride as an intravenous infusion at a dose of

Sponsors

Tehran University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 40 Years

Inclusion criteria

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

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.

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
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.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactDr. Mahmoudreza Hadjighassem

Tehran University of Medical Sciences

mhadjighassem@tums.ac.ir+98 02143052000 , +98 02188991102

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026