Back to resultsTestosterone Replacement in Middle-Aged Hypogonadal Men With Dysthymia: Parallel Group, Double Blind Randomized Trial
Primary Purpose
Dysthymic Disorder
Status
Unknown status
Phase
Phase 4
Locations
Israel
Study Type
Interventional
Intervention
Testoviron
Sponsored by
About this trial
This is an interventional treatment trial for Dysthymic Disorder focused on measuring Dysthymic Disorder, HPG hypofunctioning, Testosterone replacement
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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.
Sites / Locations
- Sheba Medical Center, Psychiatric out patient clinical unitRecruiting
Outcomes
Primary Outcome Measures
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)
Secondary Outcome Measures
Full Information
NCT ID
NCT00260390
First Posted
November 30, 2005
Last Updated
October 3, 2006
Sponsor
Sheba Medical Center
Collaborators
National Alliance for Research on Schizophrenia and Depression
1. Study Identification
Unique Protocol Identification Number
NCT00260390
Brief Title
Testosterone Replacement in Middle-Aged Hypogonadal Men With Dysthymia: Parallel Group, Double Blind Randomized Trial
Official Title
The Efficacy of Testosterone Replacement in Treating Middle-Aged Hypogonadal Men With Dysthymia: Parallel Group, Double Blind Randomized Trial
Study Type
Interventional
2. Study Status
Record Verification Date
October 2006
Overall Recruitment Status
Unknown status
Study Start Date
September 2004 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Sheba Medical Center
Collaborators
National Alliance for Research on Schizophrenia and Depression
4. Oversight
5. Study Description
Brief 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.
Hypothesis:
Testosterone replacement will be more effective than placebo, in treating men with late onset Dysthymic Disorder and hypo-gonadism.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dysthymic Disorder
Keywords
Dysthymic Disorder, HPG hypofunctioning, Testosterone replacement
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Testoviron
Primary Outcome Measure Information:
Title
Hamilton Depression Scale (HAM-d)
Title
Clinical Global Impression- Change (CGI-C)
Title
Profile of Mood States (POMS)
Title
Beck Depression Inventory (BDI)
Title
Sheehan Disability Scale
Title
Self Anchoring Scale (SAS)
Title
Affective Balance Scale (ABS)
Title
International Index of Erectile Function (IIEF)
Title
Aging Male Symptom rating (AMS)
Title
Clinical Global Impression (CGI)
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
80 Years
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Guy Orr, MD
Phone
972-52-6666577
Email
orrg@netvision.net.il
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Guy Orr, MD
Organizational Affiliation
Sheba Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sheba Medical Center, Psychiatric out patient clinical unit
City
Tel Hashomer
ZIP/Postal Code
52621
Country
Israel
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Guy Orr, MD
Phone
972-52-666577
Email
orrg@netvision.net.il
12. IPD Sharing Statement
Learn more about this trial
Testosterone Replacement in Middle-Aged Hypogonadal Men With Dysthymia: Parallel Group, Double Blind Randomized Trial
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