Testosterone and Major Depression
Condition: Major Depression
MeSH terms: Depression; Depressive Disorder; Depressive Disorder, Major
Study type: Observational

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).
    

Detailed description: 
      This study will be carried our at the Mood Disorders Psychopharmacology Unit (MDPU),
      University Health Network (UHN), University of Toronto, with the approval of the Research
      Ethics Board (REB). Informed consent will be obtained from all subjects prior to study
      enrollment.50 male subjects between the age of 40 and 65 will be evaluated by the
      psychiatrist to assess whether each patient meets DSM-IV criteria for Major Depression using
      the MINI and to obtain their medical and psychiatric history. In addition, the SEX FX
      questionnaire (an instrument measuring sexual dysfunction) will be administered. Once each
      patient has signed the informed consent document, the research staff will assess the severity
      of depressive symptoms by administering the Hamilton Depression Rating Scale (HAM-D-17). 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. Each patient will then have
      pulse, blood pressure, weight, height, waist and hip measurements taken to evaluate their
      health. Patients will be asked to provide blood (about 3 teaspoons) and urine (about 1/4 cup)
      samples for laboratory tests (bioavailable testosterone, LH, thyroid and prolactin). The
      blood samples will be obtained in the morning between 0800 and 1100 hr. Each patient will
      then be asked to complete a series of self-report measures including the SASS, the ADAM, and
      the Beck Depression Inventory.The 50 healthy controls will have a structured diagnostic
      interview (MINI) administered by the coordinator to obtain their psychiatric and medical
      history. They will undergo all laboratory tests required of the depressed population and all
      rating scales mentioned above will be completed with this population as well. Each patient is
      free to withdraw from the study at any time.
    

Observational model: Defined Population
Time perspective: Other
Keywords: Testosterone; Major Depression; Men