Obsessive Compulsive DisorderPhase 4NCT01303536
Ondansetron Augmentation in Treatment-resistant OCD
A Phase 4 study testing Ondansetron in people with Obsessive Compulsive Disorder, run by Institute of Neuroscience, Florence, Italy at 1 site in Italy.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Obsessive Compulsive Disorder
- What is being tested?
- Ondansetron
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 1 siteItaly
- Study dates
- Dec 2009to Mar 2010
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Obsessive Compulsive Disorder
- Being tested
- Ondansetron
- Medical subject headings
- Obsessive-Compulsive Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OndansetronDrug
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
| Study group | Role | What they receive |
|---|---|---|
| obsessive compulsive disorder | Experimental | 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 Receives: Drug: Ondansetron |
What is being measured
The primary outcome is the main question the study is designed to answer.
Yale Brown Obsessive Compulsive Scale
Measured: baseline
Yale Brown Obsessive Compulsive Scale
Measured: week 2
Yale Brown Obsessive Compulsive Scale
Measured: week 4
Yale Brown Obsessive Compulsive Scale
Measured: week 6
Yale Brown Obsessive Compulsive Scale
Measured: week 8
Yale Brown Obsessive Compulsive Scale
Measured: week 10
Yale Brown Obsessive Compulsive Scale
Measured: week 12
Yale Brown Obsessive Compulsive Scale
Measured: week 14
Yale Brown Obsessive Compulsive Scale
Measured: week 16
Secondary outcomes (9)
The Drug Effect scale
Measured: week 0
The Drug Effect scale
Measured: week 2
The Drug Effect scale
Measured: week 4
The Drug Effect scale
Measured: week 6
The Drug Effect scale
Measured: week 8
The Drug Effect scale
Measured: week 10
The Drug Effect scale
Measured: week 12
The Drug Effect scale
Measured: week 14
The Drug Effect scale
Measured: week 16
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2011 (estimated)
- Study startDec 2009
- Primary completionMar 2010
- Study completionMar 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obsessive Compulsive DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institute of Neuroscience, Florence, Italy
- Sponsor type
- University, hospital or other
- Investigators
- Stefano Pallanti, MD, Principal investigator, University of Florence
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01303536
- Sponsor's protocol ID
- OND2
- Status last verified
- Feb 2011
- First submitted
- 23 Feb 2011
- Last updated
- 24 Feb 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ondansetron Augmentation in Treatment-resistant OCD
- ClinicalTrials.gov ID
- NCT01303536
- Acronym / sponsor ID
- OND2
- Conditions
- Obsessive Compulsive Disorder
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Institute of Neuroscience, Florence, ItalyUniversity, hospital or other
- Study start
- Dec 2009
- Primary completion
- Mar 2010 (actual)
- Study completion
- Mar 2010 (actual)
- First posted
- 24 Feb 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| obsessive compulsive disorder | Experimental | Drug: Ondansetronobsessive 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 |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ondansetronobsessive 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 | Drug | obsessive compulsive disorder |
Primary outcome
Yale Brown Obsessive Compulsive Scale
Time frame: baseline
Yale Brown Obsessive Compulsive Scale
Time frame: week 2
Yale Brown Obsessive Compulsive Scale
Time frame: week 4
Yale Brown Obsessive Compulsive Scale
Time frame: week 6
Yale Brown Obsessive Compulsive Scale
Time frame: week 8
Yale Brown Obsessive Compulsive Scale
Time frame: week 10
Yale Brown Obsessive Compulsive Scale
Time frame: week 12
Yale Brown Obsessive Compulsive Scale
Time frame: week 14
Yale Brown Obsessive Compulsive Scale
Time frame: week 16
9 secondary outcomes
The Drug Effect scale
Time frame: week 0
The Drug Effect scale
Time frame: week 2
The Drug Effect scale
Time frame: week 4
The Drug Effect scale
Time frame: week 6
The Drug Effect scale
Time frame: week 8
The Drug Effect scale
Time frame: week 10
The Drug Effect scale
Time frame: week 12
The Drug Effect scale
Time frame: week 14
The Drug Effect scale
Time frame: week 16
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Feb 2011.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Stefano Pallanti, MD principal investigator
University of Florence
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Ondansetron in people with Obsessive Compulsive Disorder, run by Institute of Neuroscience, Florence, Italy at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Feb 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Yale Brown Obsessive Compulsive Scale (time frame: baseline). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Feb 2011.