Prurigo NodularisNCT00532519
Effectiveness of the Selective Serotonin Reuptake Inhibitor,Citalopram (Cipralex), in Prurigo Nodularis
A study testing citalopram (cipralex) in people with Prurigo Nodularis, run by Hadassah Medical Organization at 1 site in Israel.
Trial summary
Prurigo nodularis (PN) is a common dermatological disorder, manifested as scaly nodules which appear mainly on the extensor surfaces of the limbs. PN may appear secondarily to skin scratching in chronic hepatitis, liver cirrhosis, uremia, hypothyroidism etc. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Prurigo Nodularis
- What is being tested?
- citalopram (cipralex)
- How many people
- Not given
- 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 70 years
- All sexes
- Adult, Older adult
Who may be able to join
- prurigo nodularis
- age: 18-70 years
- agreed to participate
Who cannot join
- younger than 18 or older than 70
- pregnant or lactating women
- chronic diseases: cancer, neurological disorders, diseases that are known to be associated with pruritus such as liver cirrhosis, uremia, etc.
- sensitivity to cipralotam
- psychosis, bi-polar disorder, substance addiction, use of antidepressant in the previous year
- use of systemic therapies to prurigo nodularis such as thalidomide, cyclosporine
Trial locations and contacts
1 site in 1 country.
Israel1 site
: Hadassah Medical Organization,
Jerusalem
Arik Tzukert, DMD, 00 972 2 6776095, arik@hadassah.org.il
Hadas Lemberg, PhD, 00 972 2 6777572, : lhadas@hadassah.org.il
About this study
Prurigo nodularis (PN) is a common dermatological disorder, manifested as scaly nodules which appear mainly on the extensor surfaces of the limbs. PN may appear secondarily to skin scratching in chronic hepatitis, liver cirrhosis, uremia, hypothyroidism etc. Nevertheless, in many cases no underlying physical disease is present. According to the literature, in fifty percent of the patients there is co-morbidity with depression, anxiety or somatoform disorders.
We hypothesize that a group of these patients may benefit from antidepressant therapy.
- Conditions
- Prurigo Nodularis
- Being tested
- citalopram (cipralex)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
citalopram (cipralex)Drug
10-20 mg/day, for 12 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2007 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prurigo NodularisStudies of the same condition, open and under way.
- More trials run by Hadassah Medical OrganizationThe 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Sponsor and investigators
- Lead sponsor
- Hadassah Medical Organization
- Sponsor type
- University, hospital or other
- Investigators
- liran horev, md, Principal investigator, Hadassah Medical Organizationrena cooper-kazaz, md, Principal investigator, Hadassah Medical Organization
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00532519
- Sponsor's protocol ID
- horcoop-hmo-ctil
- Status last verified
- Sep 2007
- First submitted
- 19 Sep 2007
- Last updated
- 20 Sep 2007
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 20 Sep 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of the Selective Serotonin Reuptake Inhibitor,Citalopram (Cipralex), in Prurigo Nodularis
- ClinicalTrials.gov ID
- NCT00532519
- Acronym / sponsor ID
- horcoop-hmo-ctil
- Conditions
- Prurigo Nodularis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Lead sponsor
- Hadassah Medical OrganizationUniversity, hospital or other
- First posted
- 20 Sep 2007 (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.
Prurigo nodularis (PN) is a common dermatological disorder, manifested as scaly nodules which appear mainly on the extensor surfaces of the limbs. PN may appear secondarily to skin scratching in chronic hepatitis, liver cirrhosis, uremia, hypothyroidism etc. Nevertheless, in many cases no underlying physical disease is present. According to the literature, in fifty percent of the patients there is co-morbidity with depression, anxiety or somatoform disorders.
We hypothesize that a group of these patients may benefit from antidepressant therapy.
Study design
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- prurigo nodularis
- age: 18-70 years
- agreed to participate
Key exclusion criteria (6 listed)
- younger than 18 or older than 70
- pregnant or lactating women
- chronic diseases: cancer, neurological disorders, diseases that are known to be associated with pruritus such as liver cirrhosis, uremia, etc.
- sensitivity to cipralotam
- psychosis, bi-polar disorder, substance addiction, use of antidepressant in the previous year
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 |
|---|---|---|
| citalopram (cipralex)10-20 mg/day, for 12 weeks. | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Sep 2007.
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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.
liran horev, md principal investigator
Hadassah Medical Organization
rena cooper-kazaz, md principal investigator
Hadassah Medical Organization
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing citalopram (cipralex) in people with Prurigo Nodularis, run by Hadassah Medical Organization 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 3 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 20 Sep 2007. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Liran Horev, MD (OO97226777111, LIRAN_CH@BEZEQINT.NET), or a site near the patient. 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 20 Sep 2007.