OCDNCT00399022
Treatment With Duloxetine for OCD Patients
A study testing Duloxetine in people with OCD, run by Sheba Medical Center at 1 site in Israel.
Trial summary
Testing the efficacy of the SNRI medication Duloxetine for treating OCD patients who did not respond to SSRI Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- OCD
- What is being tested?
- Duloxetine
- How many people
- 40 participants
- Where
- 1 siteIsrael
- Study dates
- Start not givento not given
- Phase
- Interventional
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- OCD as main diagnosis according to DSM-IV
- Age 18 to 65
- Men and women
- YBOCS score is 18 or more, or 12 or more in case of only obsessions
Who cannot join
- Patients treated with Duloxetine, currently or in the past
- Patients having comorbid schizophrenia or psychotic disorder or bipolar disorder Patients with substance abuse disorder in the last 6 months Patients who were suicidal or did serious suicide attempt in the last year Pregnant or lactating women, or woman of childbearing potential, which is not using adequate contraception Patients with neurologic disturbance or disorder Patients with serious or imbalanced medical condition Patients with allergic response to SSRI or duloxetine Patients who started new treatment (CBT or pharmacology) in less than 3 months
Trial locations and contacts
1 site in 1 country.
About this study
Testing the efficacy of the SNRI medication Duloxetine for treating OCD patients who did not respond to SSRI
- Conditions
- OCD
- Being tested
- Duloxetine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DuloxetineDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Nov 2006 (estimated)
Why it stopped: Funding was not recieved
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OCDStudies of the same condition, open and under way.
- More trials run by Sheba Medical CenterThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sheba Medical Center
- Sponsor type
- Other government
- Investigators
- Joseph Zohar, MD, Principal investigator, Chaim Sheba Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00399022
- Sponsor's protocol ID
- SHEBA-06-4360-JZ-CTIL
- Status last verified
- Jan 2008
- First submitted
- 13 Nov 2006
- Last updated
- 31 Jan 2008
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment With Duloxetine for OCD Patients
- ClinicalTrials.gov ID
- NCT00399022
- Acronym / sponsor ID
- SHEBA-06-4360-JZ-CTIL
- Conditions
- OCD
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Funding was not recieved
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Sheba Medical CenterOther government
- First posted
- 14 Nov 2006 (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.
Testing the efficacy of the SNRI medication Duloxetine for treating OCD patients who did not respond to SSRI
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- OCD as main diagnosis according to DSM-IV
- Age 18 to 65
- Men and women
- YBOCS score is 18 or more, or 12 or more in case of only obsessions
Key exclusion criteria (2 listed)
- Patients treated with Duloxetine, currently or in the past
- Patients having comorbid schizophrenia or psychotic disorder or bipolar disorder Patients with substance abuse disorder in the last 6 months Patients who were suicidal or did serious suicide attempt in the last year Pregnant or lactating women, or woman of childbearing potential, which is not using adequate contraception Patients with neurologic disturbance or disorder Patients with serious or imbalanced medical condition Patients with allergic response to SSRI or duloxetine Patients who started new treatment (CBT or pharmacology) in less than 3 months
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 |
|---|---|---|
| Duloxetine | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jan 2008.
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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.
Joseph Zohar, MD principal investigator
Chaim Sheba Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Duloxetine in people with OCD, run by Sheba Medical Center at 1 site in Israel.
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 4 inclusion and 2 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: withdrawn, as of the sponsor's last update on 31 Jan 2008. 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 Israel. 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.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
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.
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 31 Jan 2008.