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Patients of Obsessive compulsive disorder not cured by normal medicine will be given ketamine to see the effect of the drug

Efficacy of ketamine amongst patients with treatment resistant obsessive compulsive disorder: a double blind randomized placebo control trial

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2023/05/052952
Enrollment
60
Registered
2023-05-19
Start date
Unknown
Completion date
Unknown
Last updated
2024-03-04

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

Conditions

Health Condition 1: F42- Obsessive-compulsive disorder

Interventions

Intervention1: Ketamine: Route of administration - Intravenous Dose - 0.5 mg/kg bodyweight Proper monitoring of vitals and emergence of adverse effects - atleast 2 hours Duration of theraphy - thri

Sponsors

Institute of Psychiatry COE
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: (1) Subjects were male or female (postmenopausal, surgically sterile, or negative pregnancy test at screening and agreement to utilize an established birth control, including complete abstinence, during the testing period) between the age of 18 and 65 yrs. (2) All subjects had a DSM V-TR diagnosis of Obsessive Compulsive Disorder by structured clinical interview (SCID), with a Yale-Brown Obsessive Compulsive Scale (Y-BOCS) score >24 (26, 27). (3) OCD was treatment-refractory, as defined by a Y-BOCS >24 despite two SSRI trials of adequate dose and duration and having been offered prior CBT treatment. (4) Subjects were required to have had stable doses of all psychiatric medications for the month prior to treatment and have had no changes of dosage of SSRIs or clomipramine for at least 2 months prior to study enrollment. Most subjects received their treatment elsewhere; doses and duration of previous medication trials were verified through consultation with treating psychiatrists and review of past medical and pharmacy records. 5) Subjects were medically and neurologically healthy on the basis of physical examination, medical laboratory assessment, EKG, and medical history. Individuals with stable medical conditions or taking medications without major CNS effects (e.g., oral hypoglycemics) were eligible if their medications had not been adjusted in the month prior to entry. (6) Subjects could have no lifetime history of substance dependence diagnosis by SCID (excluding tobacco)

Exclusion criteria

Exclusion criteria: 1)Subject with comorbid depression, psychosis and any organic cause resulting in psychiatric manifestation 2)Current substance abuse or alcohol dependence in past month 3)Mental retardation, pervasive developmental disorder, 4)Epilepsy and other neurological disorder 5)Any other co-morbid psychiatric illness 6)Hypertension/ cardiac morbidity 7)Raised intracranial tension 8)Acute or chronic debilitating physical illness 9)Pregnancy

Design outcomes

Primary

MeasureTime frame
A rapid improvement of obsessive compulsive symptoms amongst patient who are yet not responding to oral medicine.Timepoint: 1.5 years

Secondary

MeasureTime frame
To see the effect of ketamine as an additional therapeutic tool in treatment resistant obsessive compulsive disorder with regards to placeboTimepoint: 1.5 years

Countries

India

Contacts

Public ContactSuman Sarangi

Institute of Postgraduate Medical Education and Research

amit.bhattacharya07@gmail.com98310130143

Outcome results

None listed

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