NCT00260390

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.

Trial Health

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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2004

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

November 30, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 1, 2005

Completed
Last Updated

October 4, 2006

Status Verified

October 1, 2006

First QC Date

November 30, 2005

Last Update Submit

October 3, 2006

Conditions

Dysthymic Disorder

Keywords

Dysthymic DisorderHPG hypofunctioningTestosterone replacement

Outcome Measures

Primary Outcomes (10)

  • 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)

Interventions

TestovironDRUG

Eligibility Criteria

Age40 Years - 80 Years
Sexmale
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sheba Medical Center, Psychiatric out patient clinical unit

Tel Litwinsky, 52621, Israel

RECRUITING

MeSH Terms

Conditions

Dysthymic Disorder

Interventions

Methyltestosterone

Condition Hierarchy (Ancestors)

Depressive DisorderMood DisordersMental Disorders

Intervention Hierarchy (Ancestors)

TestosteroneAndrostenolsAndrostenesAndrostanesSteroidsFused-Ring CompoundsPolycyclic Compounds

Study Officials

  • Guy Orr, MD

    Sheba Medical Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Guy Orr, MD

CONTACT

972-52-6666577orrg@netvision.net.il

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV

Study Record Dates

First Submitted

November 30, 2005

First Posted

December 1, 2005

Study Start

September 1, 2004

Last Updated

October 4, 2006

Record last verified: 2006-10

Locations

IL(1)