Dysthymic Disorder
Conditions
Keywords
Dysthymic Disorder, HPG hypofunctioning, Testosterone replacement
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.
Interventions
DRUGTestoviron
Sponsors
National Alliance for Research on Schizophrenia and Depression
Sheba Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE
Eligibility
Sex/Gender
MALE
Age
40 Years to 80 Years
Inclusion criteria
1. Male, age 40-80 years. 2. Diagnosed with hypogonadism (total T level below 350 ng/dl), but not previously treated. 3. Diagnosis of Dysthymic disorder with onset after age 40. 4. PSA \< 4.0. 5. Normal digital exam of the prostate in the preceding 1 year. 6. 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). 7. Able to give informed consent.
Exclusion criteria
1. Acute, severe, or unstable prostatitis, symptomatic prostatic hypertrophy, polycythemia, severe acne, breast cancer, prostate cancer, or hypopituitarism. 2. Currently being treated with testosterone. 3. 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. 4. Current suicidal risk. 5. Current (past year) substance abuse or dependence.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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) | — |
Countries
Israel
Contacts
Primary ContactGuy Orr, MD
Outcome results
None listed