FibromyalgiaNCT00229294
Fibromyalgia in Men Suffering From PTSD
An observational study of Fibromyalgia and Posttraumatic Stress Disorder, run by Sheba Medical Center.
Trial summary
Assessing FM and psychiatric state among PTSD, MDD and healthy participants Read more about this study
- Who is it for?
- Ages 20 to 60 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Fibromyalgia, Posttraumatic Stress Disorder, Major Depressive Disorder
- How many people
- Not given
- Where
- No sites listed yet
- Study dates
- Mar 2004to Mar 2005
- Phase
- Observational
- 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 20 to 60 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy volunteers without any current or past psychiatric disorder
- Current diagnosis of PTSD
- Current diagnosis of MDD
Who cannot join
- Psychotic features
About this study
Assessing FM and psychiatric state among PTSD, MDD and healthy participants
- Medical subject headings
- Fibromyalgia, Stress Disorders, Post-Traumatic, Depressive Disorder, Major
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2005 (estimated)
- Study startMar 2004
- Study completionMar 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for FibromyalgiaStudies 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
- Observational
- Time perspective
- Retrospective
Sponsor and investigators
- Lead sponsor
- Sheba Medical Center
- Sponsor type
- Other government
- Investigators
- Joseph Zohar, MD, Principal investigator, Tel Aviv University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00229294
- Sponsor's protocol ID
- SHEBA- 03-2925-JZ-CTIL
- Status last verified
- Dec 2007
- First submitted
- 28 Sep 2005
- Last updated
- 27 Dec 2007
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Dec 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fibromyalgia in Men Suffering From PTSD
- ClinicalTrials.gov ID
- NCT00229294
- Acronym / sponsor ID
- SHEBA- 03-2925-JZ-CTIL
- Study type
- Observational
- Recruitment status
- Completed
- Lead sponsor
- Sheba Medical CenterOther government
- Study start
- Mar 2004
- Study completion
- Mar 2005
- First posted
- 29 Sep 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 FM and psychiatric state among PTSD, MDD and healthy participants
Study design
- Time perspective
- Retrospective
Who may qualify
- Ages
- 20 to 60 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Healthy volunteers without any current or past psychiatric disorder
- Current diagnosis of PTSD
- Current diagnosis of MDD
Key exclusion criteria (1 listed)
- Psychotic features
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
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 27 Dec 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.
Joseph Zohar, MD principal investigator
Tel Aviv University
Questions about this trial
What is this clinical trial studying?
An observational study of Fibromyalgia and Posttraumatic Stress Disorder, run by Sheba Medical Center.
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 1 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 27 Dec 2007. Status can change between updates, so confirm with the study contact before making plans.
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 27 Dec 2007.