Dysthymic DisorderPhase 4NCT00260390
Testosterone Replacement in Middle-Aged Hypogonadal Men With Dysthymia: Parallel Group, Double Blind Randomized Trial
A Phase 4 study testing Testoviron in people with Dysthymic Disorder, run by Sheba Medical Center at 1 site in Israel.
Trial summary
Growing evidence supports the notion that Late-onset Dysthymic disorder in middle aged men may be associated with age-related HPG hypofunctioning. In this study we seek to examine the efficacy of Testosterone replacement for this condition. Read more about this study
- Who is it for?
- Ages 40 to 80 years, men only
- Conditions the study is for
- Dysthymic Disorder
- What is being tested?
- Testoviron
- How many people
- Not given
- Where
- 1 siteIsrael
- Study dates
- Sep 2004to not given
- 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 40 to 80 years
- Men only
- Adult, Older adult
Who may be able to join
- Male, age 40-80 years.
- Diagnosed with hypogonadism (total T level below 350 ng/dl), but not previously treated.
- Diagnosis of Dysthymic disorder with onset after age 40.
- PSA < 4.0.
- Normal digital exam of the prostate in the preceding 1 year.
- For subjects currently taking an antidepressant: Current antidepressant treatment last 6 weeks or longer, with decent dose and with no remission (or with partial remission only HAM-D > 12).
- Able to give informed consent.
Who cannot join
- Acute, severe, or unstable prostatitis, symptomatic prostatic hypertrophy, polycythemia, severe acne, breast cancer, prostate cancer, or hypopituitarism.
- Currently being treated with testosterone.
- Meets lifetime criteria for schizophrenia, schizoaffective disorder, any bipolar disorder (i.e., BP-I, BP-II, or BP NOS); or a major depressive episode in the preceding 5 years.
- Current suicidal risk.
- Current (past year) substance abuse or dependence.
Trial locations and contacts
1 site in 1 country.
Israel1 site, 1 recruiting
- Recruiting
Sheba Medical Center, Psychiatric out patient clinical unit
Tel HaShomer, 52621
Guy Orr, MD, 972-52-666577, orrg@netvision.net.il
About this study
Official title: The Efficacy of Testosterone Replacement in Treating Middle-Aged Hypogonadal Men With Dysthymia: Parallel Group, Double Blind Randomized Trial
Growing evidence supports the notion that Late-onset Dysthymic disorder in middle aged men may be associated with age-related HPG hypofunctioning. In this study we seek to examine the efficacy of Testosterone replacement for this condition.
Hypothesis:
Testosterone replacement will be more effective than placebo, in treating men with late onset Dysthymic Disorder and hypo-gonadism.
- Conditions
- Dysthymic Disorder
- Being tested
- Testoviron
- Keywords
- Dysthymic Disorder, HPG hypofunctioning, Testosterone replacement
- Medical subject headings
- Dysthymic Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TestovironDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Hamilton Depression Scale (HAM-d)
Clinical Global Impression- Change (CGI-C)
Profile of Mood States (POMS)
Beck Depression Inventory (BDI)
Sheehan Disability Scale
Self Anchoring Scale (SAS)
Affective Balance Scale (ABS)
International Index of Erectile Function (IIEF)
Aging Male Symptom rating (AMS)
Clinical Global Impression (CGI)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Dec 2005 (estimated)
- Study startSep 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dysthymic 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Sponsor and investigators
- Lead sponsor
- Sheba Medical Center
- Sponsor type
- Other government
- Collaborators
- National Alliance for Research on Schizophrenia and Depression
- Investigators
- Guy Orr, MD, Principal investigator, Sheba Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00260390
- Sponsor's protocol ID
- SHEBA-04-3222-GO-CTIL
- Status last verified
- Oct 2006
- First submitted
- 30 Nov 2005
- Last updated
- 4 Oct 2006
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Oct 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy of Testosterone Replacement in Treating Middle-Aged Hypogonadal Men With Dysthymia: Parallel Group, Double Blind Randomized Trial
- ClinicalTrials.gov ID
- NCT00260390
- Acronym / sponsor ID
- SHEBA-04-3222-GO-CTIL
- Conditions
- Dysthymic Disorder
- Keywords
- Dysthymic Disorder, HPG hypofunctioning, Testosterone replacement
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Lead sponsor
- Sheba Medical CenterOther government
- Collaborators
- National Alliance for Research on Schizophrenia and Depression
- Study start
- Sep 2004
- First posted
- 1 Dec 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.
Growing evidence supports the notion that Late-onset Dysthymic disorder in middle aged men may be associated with age-related HPG hypofunctioning. In this study we seek to examine the efficacy of Testosterone replacement for this condition.
Hypothesis:
Testosterone replacement will be more effective than placebo, in treating men with late onset Dysthymic Disorder and hypo-gonadism.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 40 to 80 years
- Sex
- Male only
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Male, age 40-80 years.
- Diagnosed with hypogonadism (total T level below 350 ng/dl), but not previously treated.
- Diagnosis of Dysthymic disorder with onset after age 40.
- PSA < 4.0.
- Normal digital exam of the prostate in the preceding 1 year.
Key exclusion criteria (5 listed)
- Acute, severe, or unstable prostatitis, symptomatic prostatic hypertrophy, polycythemia, severe acne, breast cancer, prostate cancer, or hypopituitarism.
- Currently being treated with testosterone.
- Meets lifetime criteria for schizophrenia, schizoaffective disorder, any bipolar disorder (i.e., BP-I, BP-II, or BP NOS); or a major depressive episode in the preceding 5 years.
- Current suicidal risk.
- Current (past year) substance abuse or dependence.
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 |
|---|---|---|
| Testoviron | Drug | – |
Primary outcome
Hamilton Depression Scale (HAM-d)
Clinical Global Impression- Change (CGI-C)
Profile of Mood States (POMS)
Beck Depression Inventory (BDI)
Sheehan Disability Scale
Self Anchoring Scale (SAS)
Affective Balance Scale (ABS)
International Index of Erectile Function (IIEF)
Aging Male Symptom rating (AMS)
Clinical Global Impression (CGI)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Oct 2006.
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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.
Guy Orr, MD principal investigator
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 Phase 4 study testing Testoviron in people with Dysthymic 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 7 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: status not confirmed, as of the sponsor's last update on 4 Oct 2006. 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.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Guy Orr, MD (972-52-6666577, orrg@netvision.net.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hamilton Depression Scale (HAM-d). The study lists 10 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 4 Oct 2006; AzTrials last refreshed its copy on 1 Nov 2026.