Status:
COMPLETED
Testosterone and Major Depression
Lead Sponsor:
University Health Network, Toronto
Conditions:
Major Depression
Eligibility:
MALE
40-65 years
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 m...
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). Infor...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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)
Key Trial Info
Start Date :
January 1 2001
Trial Type :
OBSERVATIONAL
End Date :
August 1 2005
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT00286546
Start Date
January 1 2001
End Date
August 1 2005
Last Update
September 11 2006
Active Locations (1)
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1
Toronto Western Hospital
Toronto, Ontario, Canada, M5T 2S8