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

This study is currently recruiting participants.

Verified by Sheba Medical Center, October 2006

First Received: November 30, 2005 Last Updated: October 3, 2006 History of Changes

Sponsor:	Sheba Medical Center
Collaborator:	National Alliance for Research on Schizophrenia and Depression
Information provided by:	Sheba Medical Center
ClinicalTrials.gov Identifier:	NCT00260390

Purpose

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.

Condition	Intervention	Phase
Dysthymic Disorder	Drug: Testoviron	Phase IV

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study
Official Title:	The Efficacy of Testosterone Replacement in Treating Middle-Aged Hypogonadal Men With Dysthymia: Parallel Group, Double Blind Randomized Trial

Resource links provided by NLM:

MedlinePlus related topics: Depression

Drug Information available for: Testosterone Propionate Methyltestosterone Testosterone Oxymesterone Testosterone enanthate Testosterone undecanoate

U.S. FDA Resources

Further study details as provided by Sheba Medical Center:

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)

Study Start Date:

September 2004

Eligibility

Ages Eligible for Study:	40 Years to 80 Years
Genders Eligible for Study:	Male

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00260390

Contacts

Contact: Guy Orr, MD

972-52-6666577

orrg@netvision.net.il

Locations

Israel
Sheba Medical Center, Psychiatric out patient clinical unit	Recruiting
Tel Hashomer, Israel, 52621
Contact: Guy Orr, MD 972-52-666577 orrg@netvision.net.il

Sponsors and Collaborators

Sheba Medical Center

National Alliance for Research on Schizophrenia and Depression

Investigators

Principal Investigator:

Guy Orr, MD

Sheba Medical Center

More Information

No publications provided

Study ID Numbers:	SHEBA-04-3222-GO-CTIL
Study First Received:	November 30, 2005
Last Updated:	October 3, 2006
ClinicalTrials.gov Identifier:	NCT00260390 History of Changes
Health Authority:	Israel: Israeli Health Ministry Pharmaceutical Administration

Keywords provided by Sheba Medical Center:

Dysthymic Disorder
HPG hypofunctioning
Testosterone replacement

Additional relevant MeSH terms:

Disease
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists
Methyltestosterone
Depressive Disorder
Hormones
Pharmacologic Actions

Testosterone 17 beta-cypionate
Anabolic Agents
Testosterone
Pathologic Processes
Mental Disorders
Therapeutic Uses
Mood Disorders
Dysthymic Disorder
Androgens

ClinicalTrials.gov processed this record on February 08, 2010