Obsessive Compulsive DisorderNCT00234689
Efficacy of Naltrexone Treatment as Augmentation to SSRI in OCD Patients
A study testing Naltrexone in people with Obsessive Compulsive Disorder, run by Sheba Medical Center at 1 site in Israel.
Trial summary
Assessing the efficacy of Naltrexone as augmentation to SSRI in patients with OCD Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Obsessive Compulsive Disorder
- What is being tested?
- Naltrexone
- How many people
- Not given
- Where
- 1 siteIsrael
- Study dates
- Jan 2002to Dec 2004
- 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
- Diagnosis of OCD
- Treatment with SSRI for at least 10 weeks with no response
Who cannot join
- Suffering from any medical condition
- treatment with opiates
- chronic use of drugs
- Hepatitis or other liver related diseases
- Incapability to sign an informed consent
Trial locations and contacts
1 site in 1 country.
About this study
Assessing the efficacy of Naltrexone as augmentation to SSRI in patients with OCD
- Conditions
- Obsessive Compulsive Disorder
- Being tested
- Naltrexone
- 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.
NaltrexoneDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Oct 2005 (estimated)
- Study startJan 2002
- Primary completionDec 2004
- Study completionDec 2004
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.
- 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
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
Sponsor and investigators
- Lead sponsor
- Sheba Medical Center
- Sponsor type
- Other government
- Investigators
- Joseph Zohar, MD, Principal investigator, Tel Aviv UniversityRevital Amiaz, MD, Study chair, Tel Aviv University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00234689
- Sponsor's protocol ID
- SHEBA-99-1897-JZ-CTIL
- Status last verified
- Jan 2008
- First submitted
- 6 Oct 2005
- Last updated
- 30 Jan 2008
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Naltrexone Treatment as Augmentation to SSRI in OCD Patients
- ClinicalTrials.gov ID
- NCT00234689
- Acronym / sponsor ID
- SHEBA-99-1897-JZ-CTIL
- Conditions
- Obsessive Compulsive Disorder
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- Sheba Medical CenterOther government
- Study start
- Jan 2002
- Primary completion
- Dec 2004 (actual)
- Study completion
- Dec 2004 (actual)
- First posted
- 7 Oct 2005 (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.
Assessing the efficacy of Naltrexone as augmentation to SSRI in patients with OCD
Study design
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Diagnosis of OCD
- Treatment with SSRI for at least 10 weeks with no response
Key exclusion criteria (5 listed)
- Suffering from any medical condition
- treatment with opiates
- chronic use of drugs
- Hepatitis or other liver related diseases
- Incapability to sign an informed consent
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 |
|---|---|---|
| Naltrexone | Drug | – |
Primary outcome
Not reported in the source record.
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 30 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
Tel Aviv University
Revital Amiaz, MD study chair
Tel Aviv University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Naltrexone in people with Obsessive Compulsive Disorder, 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 2 inclusion and 5 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 30 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 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.
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 30 Jan 2008.