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Evaluation of Ondansetron effect in treatment resistant Obsessive Compulsive disorder

Evaluation of Ondansetron augmentation therapeutic effectiveness in Obsessive Compulsive disorder patients resistant to treatment by selective serotonin reuptake inhibitor: Double-blind randomized clinical trial with placebo control

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT20250523065856N1
Enrollment
40
Registered
2025-12-15
Start date
2025-06-01
Completion date
Unknown
Last updated
2026-02-02

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: The intervention group is a group of 20 people who will receive ondansetron by a medical assistant. This medication belongs to the class of serotonin 5-HT3 receptor

Sponsors

Rasht University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 50 Years

Inclusion criteria

Inclusion criteria: Diagnosis of obsessive-compulsive disorder based on the Diagnostic and Statistical Manual of Mental Disorders – Fifth Edition Age range: 18 to 50 years Total score of the Yale-Brown Obsessive Compulsive Scale above 16 Ventricular electrical(QT)interval less than 420 milliseconds on ECG prior to the start of the study No history of prolonged ventricular electrical interval syndrome in the patient or their family

Exclusion criteria

Exclusion criteria: Active phase of psychotic disorders such as schizophrenia and major depression Concurrent serious medical illness including hepatic, renal, and electrolyte problems (any abnormal paraclinical findings in serum urea,creatinin,liver function test,blood chemistry) Cardiac problems in the individual (including structural, conduction, or vascular disorders) or a family history of cardiac conduction disorders Structural brain disease Alcohol and substance use Intellectual disability Pregnancy and breastfeeding period Undergoing any form of psychotherapy at present

Design outcomes

Primary

MeasureTime frame
Obsessive Compulsive Disorder symptom severity based on the Yale-Brown Obsessive Compulsive Scale. Timepoint: Before the intervention, 8 weeks and 12 weeks after the start of the intervention. Method of measurement: Yale-Brown Obsessive Compulsive Scale.

Secondary

MeasureTime frame
Response to treatment(more than 35% reduction in Yale-Brown Obsessive Compulsive Scale ). Timepoint: Before the intervention, 8 weeks and 12 weeks after the start of the intervention. Method of measurement: Yale-Brown Obsessive Compulsive Scale.;Safety of ondansetron. Timepoint: Before the intervention, 8 weeks and 12 weeks after the start of the intervention. Method of measurement: Clinical interview.;Tolerability of ondansetron (QT interval changes). Timepoint: Before the intervention, 8 weeks and 12 weeks after the start of the intervention. Method of measurement: Electerocardiography.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactNadia Vakili Sadeghi

Rasht University of Medical Sciences

n.vakilisadeghi@bpums.ac.ir+98 13 3211 4085

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 7, 2026