Major DepressionNCT00286546
Testosterone and Major Depression
An observational study of Major Depression, run by University Health Network, Toronto at 1 site in Canada.
Trial 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… Read more about this study
- Who is it for?
- Ages 40 to 65 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Major Depression
- How many people
- 100 participants
- Where
- 1 siteCanada
- Study dates
- Jan 2001to Aug 2005
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 65 years
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Role of Testosterone in Major Depression
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).
Read the 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.
- Conditions
- Major Depression
- Keywords
- Testosterone, Major Depression, Men
- Medical subject headings
- Depressive Disorder, Major, Multiple Endocrine Neoplasia Type 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Feb 2006 (estimated)
- Study startJan 2001
- Study completionAug 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Major DepressionStudies of the same condition, open and under way.
- More trials run by University Health Network, TorontoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Defined population
- Time perspective
- Other
- Enrolment
- 100 participants
Sponsor and investigators
- Lead sponsor
- University Health Network, Toronto
- Sponsor type
- University, hospital or other
- Investigators
- Roger McIntyre, MD, FRCPC, Principal investigator, University Health Network, University of TorontoRoger McIntyre, Principal investigator, UHN Toronto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00286546
- Sponsor's protocol ID
- 002
- Status last verified
- Aug 2005
- First submitted
- 1 Feb 2006
- Last updated
- 11 Sep 2006
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of Testosterone in Major Depression
- ClinicalTrials.gov ID
- NCT00286546
- Acronym / sponsor ID
- 002
- Conditions
- Major Depression
- Keywords
- Testosterone, Major Depression, Men
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants
- Lead sponsor
- University Health Network, TorontoUniversity, hospital or other
- Study start
- Jan 2001
- Study completion
- Aug 2005
- First posted
- 3 Feb 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Defined population
- Time perspective
- Other
Who may qualify
- Ages
- 40 to 65 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Sep 2006.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Roger McIntyre, MD, FRCPC principal investigator
University Health Network, University of Toronto
Roger McIntyre principal investigator
UHN Toronto
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Major Depression, run by University Health Network, Toronto at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Sep 2006. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Sep 2006.