Ignite Creation Date:
2024-05-05 @ 4:37 PM
Last Modification Date:
2024-10-26 @ 9:22 AM
Study NCT ID:
NCT00286546
Status:
COMPLETED
Last Update Posted:
2006-09-11
First Post:
2006-02-01
Brief Title:
Testosterone and Major Depression
Sponsor:
University Health Network Toronto
Organization:
University Health Network Toronto
Study Overview
Official Title:
The Role of Testosterone in Major Depression
Status:
COMPLETED
Status Verified Date:
2005-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 depressionObjective - 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 65Design 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 SymptomSide 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 enrollment50 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 SymptomSide 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 14 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 InventoryThe 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None