Testosterone and Major Depression

NCT00286546 | Completed

• 1 other identifier: 002
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

Context - As men age, testosterone levels decline leading to symptoms that overlap with the symptoms of major depression. Little is known about the potential role of testosterone in the treatment of major depression.Objective - To assess the levels of bioavailable testosterone and total levels of testosterone in men diagnosed with major depressive disorder between the ages of 40 and 65.Design, Setting and Participants - 50 men between the ages of 40 and 65 and who suffer from major depressive disorder will be compared with 50 age matched healthy controls in an outpatient hospital setting. Main Outcome Measures - Bioavailable testosterone and total testosterone levels will be measured as well as blood pressure, pulse rate, height, weight, waist and hip measurements. Medical and psychiatric history will be assessed by the study physician. The Mini International Neuropsychiatric Interview (MINI) will be used to administered by the physician to ensure that the patient meets the DSM-IV criteria for Major Depression. The Hamilton Depression Rating Scale (HAM-D-17) will be used to assess depression symptom severity. A Symptom/Side Effect Rating Scale will also be administered to measure the presence and severity of side effects that each patient may be experiencing. In addition, the SEX FX questionnaire will be administered. Each patient will be asked to complete a series of self-report measures including the Social Adaptation Self-Evaluation Scale Questionnaire (SASS), the Androgen Deficiency in Aging Males (ADAM) and the Beck Depression Inventory (BDI-II).

Conditions

Major Depression

Keywords

Testosterone; Major Depression; Men

Eligibility Criteria

• Age: 40 Years - 65 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Meets DSM IV criteria for a diagnosis of Major Depressive Disorder as per an assessment by the PREN physician-investigator.
• Subjects must have a Hamilton Depression Rating Scale (HAM-D-17) of at least 16.
• Subjects must be male between the ages of 40 and 65.
• Subjects must be judged by the investigator to be in generally good health.
• Body Mass Index (BMI) between 20 to 29 kg/m2.
• Able and willing to give meaningful written consent.
• Educational level and a degree of understanding such that they can communicate effectively with the Investigator.
• Subjects must have had normal sexual functioning prior to the onset of depression.

You may not qualify if:

• Subjects must not suffer from clinically significant medical conditions. Examples include neurological, cardiovascular, gastrointestinal, hepatic, renal, haematological, respiratory or endocrine illnesses.
• Recent history of drug or alcohol abuse/dependence within the past 6 months as defined by DSM-IV or in the opinion of the investigator.
• Uncorrected hypothyroidism or hyperthyroidism.
• Current use of hormone replacement therapy.
• Current diagnosis of schizophrenia or other psychotic disorder (including psychotic disorder due to general medical condition, substance-induced psychotic disorder, psychotic disorder not otherwise specified) as defined in the DSM-IV.
• Current diagnosis of depressive disorder not otherwise specified or bipolar I disorder, most recent episode major depression mixed or manic bipolar II disorder as defined in the DSM-IV.
• Electroconvulsive therapy (ECT) within the 3 months prior to visit 1.
• Not currently on any antidepressants or must have an interval of the following prior to entry into the study: Fluoxetine-4 weeks; MAOIs- 2 weeks
• All other psychotic medications and herbal preparations with putative antidepressant properties (e.g. paroxetine HCI, other antidepressant not specified above, St. John's Wort, kava-kava or Valerian: 1 week)

Sponsors & Collaborators

• University Health Network, Toronto: lead

Study Sites (1)

Toronto Western Hospital

Toronto, Ontario, M5T 2S8, Canada

Location

MeSH Terms

Conditions

Depressive Disorder, Major; Multiple Endocrine Neoplasia Type 1

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders; Multiple Endocrine Neoplasia; Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Neoplasms, Multiple Primary; Neoplastic Syndromes, Hereditary; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Endocrine System Diseases

Study Officials

• Roger McIntyre, MD, FRCPC

  University Health Network, University of Toronto

  PRINCIPAL INVESTIGATOR

• Roger McIntyre

  UHN Toronto

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: DEFINED POPULATION
• Time Perspective: OTHER
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: February 1, 2006
• First Posted: February 3, 2006
• Study Start: January 1, 2001
• Study Completion: August 1, 2005
• Last Updated: September 11, 2006

Record last verified: 2005-08

Locations

CA (1)