Testosterone Replacement in Middle-Aged Hypogonadal Men With Dysthymia: Parallel Group, Double Blind Randomized Trial

Sheba Medical Center

Status and phase: Unknown; Phase 4

Conditions: Dysthymic Disorder

Treatments: Drug: Testoviron

Study type: Interventional

Funder types: Other

Identifiers

NCT00260390

SHEBA-04-3222-GO-CTIL

Details and patient eligibility

About

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.

Sex: Male

Ages: 40 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind