Testosterone and Major Depression
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT00286546 |
Recruitment Status :
Completed
First Posted : February 3, 2006
Last Update Posted : September 11, 2006
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Condition or disease |
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Major Depression |
Study Type : | Observational |
Enrollment : | 100 participants |
Observational Model: | Defined Population |
Time Perspective: | Other |
Official Title: | The Role of Testosterone in Major Depression |
Study Start Date : | January 2001 |
Study Completion Date : | August 2005 |


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Ages Eligible for Study: | 40 Years to 65 Years (Adult, Older Adult) |
Sexes Eligible for Study: | Male |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
- 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 Criteria:
- 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)

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00286546
Canada, Ontario | |
Toronto Western Hospital | |
Toronto, Ontario, Canada, M5T 2S8 |
Principal Investigator: | Roger McIntyre, MD, FRCPC | University Health Network, University of Toronto | |
Principal Investigator: | Roger McIntyre | UHN Toronto |
ClinicalTrials.gov Identifier: | NCT00286546 |
Other Study ID Numbers: |
002 |
First Posted: | February 3, 2006 Key Record Dates |
Last Update Posted: | September 11, 2006 |
Last Verified: | August 2005 |
Testosterone Major Depression Men |
Depression Depressive Disorder Depressive Disorder, Major |
Behavioral Symptoms Mood Disorders Mental Disorders |