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Completed

NCT Number: NCT01303536

Ondansetron Augmentation in Treatment-resistant OCD

The aim of this study is to evaluate whether ondansetron augmentation to SSRI will improve and ondansetron discontinuation will result in worsening of obsessive compulsive symptoms among obsessive compulsive disorder resistant patients.

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Key information

Conditions

Obsessive Compulsive Disorder Anxiety Disorders Mental Disorders Obsessive-Compulsive Disorder

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Institute of Neuroscience

Florence, 50137, Italy

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • a diagnosis of OCD established by clinical interview with a licensed psychiatrist;
  • a score of ≥ 24 at the Yale Brown Obsessive Compulsive Scale
  • a Clinical Global Inventory score ≥ 4, after over 12 weeks of treatment with an adequate trial of an selective serotonin reuptake inhibitor at a moderate to high dose

Exclusion criteria

  • diagnoses of schizophrenia, schizoaffective disorder, organic mental disorder, bipolar disorder, current substance dependence or abuse, and current major depressive episode preceding the onset of obsessive compulsive disorder
  • undergoing concomitant behavior therapy
  • or having significant cardiovascular, hepatic, renal or pulmonary diseases

Treatment and study plan

ondansetron

Drug

obsessive compulsive patients resistant to selective serotonin reuptake inhibitor therapy, in addition to their continued stable dose of FDA approved selective serotonin reuptake inhibitors, received oral ondansetron 0.25 mg in two daily administrations (0.5 mg daily) for 2 weeks. Subsequently, the dose was titrated to 0.5 mg in two daily administrations (1 mg/day total) for another 10 weeks. ondansetron was discontinued and the patients were followed for an additional 4 week with biweekly

Primary outcomes

  1. Yale Brown Obsessive Compulsive Scale

    Time frame: baseline

  2. Yale Brown Obsessive Compulsive Scale

    Time frame: week 2

  3. Yale Brown Obsessive Compulsive Scale

    Time frame: week 4

  4. Yale Brown Obsessive Compulsive Scale

    Time frame: week 6

  5. Yale Brown Obsessive Compulsive Scale

    Time frame: week 8

  6. Yale Brown Obsessive Compulsive Scale

    Time frame: week 10

  7. Yale Brown Obsessive Compulsive Scale

    Time frame: week 12

  8. Yale Brown Obsessive Compulsive Scale

    Time frame: week 14

  9. Yale Brown Obsessive Compulsive Scale

    Time frame: week 16

Secondary outcomes

  1. The Drug Effect scale

    Time frame: week 0

  2. The Drug Effect scale

    Time frame: week 2

  3. The Drug Effect scale

    Time frame: week 4

  4. The Drug Effect scale

    Time frame: week 6

  5. The Drug Effect scale

    Time frame: week 8

  6. The Drug Effect scale

    Time frame: week 10

  7. The Drug Effect scale

    Time frame: week 12

  8. The Drug Effect scale

    Time frame: week 14

  9. The Drug Effect scale

    Time frame: week 16

Sponsors and collaborators

Lead sponsor

Institute of Neuroscience, Florence, Italy

Other

Registry information

Important dates

Study start
2009
Primary completion
2010
Study completion
2010
First posted
Feb 24, 2011
Registry last updated
Feb 24, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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