Depressive Disorder, MajorPhase 4NCT00304746
AndroGel in Men With Major Depression and Incomplete Response to Antidepressant Treatment
A Phase 4 study testing Testosterone gel in people with Depressive Disorder, Major, run by Mclean Hospital at 2 sites in 2 countries.
Trial summary
We hypothesize that AndroGel may offer some relief to subjects with low or borderline testosterone levels who suffer from depression and have failed to respond to a trial of a standard antidepressant. Read more about this study
- Who is it for?
- Ages 30 to 65 years, men only
- Conditions the study is for
- Depressive Disorder, Major
- What is being tested?
- Testosterone gel
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 2 sitesin 2 countries
- Study dates
- Apr 2006to Apr 2009
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 30 to 65 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male
- 30-65 years old
- Taking at least one serotonergic antidepressant at adequate dose for at least six weeks but still meeting DSM-IV criteria for major depressive disorder within the past year
- HAM-D score >12
Who cannot join
- Current suicidal ideation
- Substance abuse or dependence within the past year
- Current or past psychotic symptoms
- A history of bipolar disorder
- A prostate-specific antigen (PSA) level greater than 4.0 ng/ml
- Other clinically significant medical condition
- A history of failing to show any clinically significant response to two or more adequate trials of different antidepressants.
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
About this study
Official title: A Parallel-Group, Placebo-Controlled Trial of AndroGel in Men With Major Depressive Disorder Who Display an Incomplete Response to Standard Antidepressant Treatment
We hypothesize that AndroGel may offer some relief to subjects with low or borderline testosterone levels who suffer from depression and have failed to respond to a trial of a standard antidepressant.
During this nine week, outpatient, double-blind study, male subjects between the ages of 30 and 65 years with treatment-refractory depression and low or borderline low testosterone levels will be treated with either AndroGel or placebo. Following this nine week, double-blind phase, eligible subjects will have the option to continue into a six month, open-label phase during which time all subjects will receive the AndroGel patch.
Read the detailed description
We will recruit 100 men between the ages of 30 and 65 years who have treatment-refractory depression and low or borderline low testosterone levels for participation in this study. For a period of nine weeks subjects will receive double-blind treatment with either AndroGel (testosterone gel) or placebo. During this double-blind treatment phase subjects will come to McLean Hospital for a total of seven visits. Both clinical assessments (including ratings of your levels of depression and anxiety, quality of life, and visuospatial memory)and laboratory tests will be performed at these visits. Following the nine week, double-blind phase, eligible subjects may enter into a six month, open-label treatment phase in which all subject receive AndroGel. If you participate in the open-label phase, you will be asked to return to the site for 8 visits during the six month period.
- Conditions
- Depressive Disorder, Major
- Being tested
- Testosterone gel, Placebo
- Medical subject headings
- Depressive Disorder, Major
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Testosterone gelDrug
Also called AndroGel
AndroGel 2.5g and 5g sachets at doses ranging from 10g/day for duration of trial.
PlaceboDrug
Placebo
| Study group | Role | What they receive |
|---|---|---|
| testosterone gel | Active comparator | AndroGel (1% testosterone transdermal gel), 2.5 g to 10 g daily Receives: Drug: Testosterone gel |
| placebo gel | Placebo comparator | Placebo gel Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
21-item Hamilton Depression Rating Scale Score (HAM-D)
The HAM-D generates a score ranging from 0 (no depressive symptoms) to 64 (most severe depression).
Measured: 9 weeks (1-week placebo lead-in and 8 weeks of blinded medication treatment)
Secondary outcomes (1)
Montgomery Asberg Depression Rating Scale (MADRS)
The Montgomery Asberg Depression Rating Scale (MADRS) is a clinician-assessed scale that rates depressive symptoms on a scale from 0 (no depressive symptoms) to 60 (maximal depressive symptoms).
Measured: 9 weeks (1 week of placebo lead-in and 8 weeks of blinded medication treatment)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2006 (estimated)
- Study startApr 2006
- Primary completionDec 2008
- Study completionApr 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Depressive Disorder, MajorStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mclean Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Solvay Pharmaceuticals
- Investigators
- Harrison G Pope, M.D., Principal investigator, Mclean HospitalStuart N Seidman, M.D., Principal investigator, Columbia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00304746
- Sponsor's protocol ID
- 2005P-001667
- Status last verified
- Nov 2010
- First submitted
- 16 Mar 2006
- Last updated
- 24 Nov 2010
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Pope HG Jr, Amiaz R, Brennan BP, Orr G, Weiser M, Kelly JF, Kanayama G, Siegel A, Hudson JI, Seidman SN. Parallel-group placebo-controlled trial of testosterone gel in men with major depressive disorder displaying an incomplete response to standard antidepressant treatment. J Clin Psychopharmacol. 2010 Apr;30(2):126-34. doi: 10.1097/JCP.0b013e3181d207ca.
PubMed 20520285
Study at a glance
From the registry record, last updated by the sponsor on 24 Nov 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Parallel-Group, Placebo-Controlled Trial of AndroGel in Men With Major Depressive Disorder Who Display an Incomplete Response to Standard Antidepressant Treatment
- ClinicalTrials.gov ID
- NCT00304746
- Acronym / sponsor ID
- 2005P-001667
- Conditions
- Depressive Disorder, Major
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Mclean HospitalUniversity, hospital or other
- Collaborators
- Solvay Pharmaceuticals
- Study start
- Apr 2006
- Primary completion
- Dec 2008 (actual)
- Study completion
- Apr 2009 (actual)
- First posted
- 20 Mar 2006 (estimated)
- Results
- Posted 17 Nov 2010
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
We hypothesize that AndroGel may offer some relief to subjects with low or borderline testosterone levels who suffer from depression and have failed to respond to a trial of a standard antidepressant.
During this nine week, outpatient, double-blind study, male subjects between the ages of 30 and 65 years with treatment-refractory depression and low or borderline low testosterone levels will be treated with either AndroGel or placebo. Following this nine week, double-blind phase, eligible subjects will have the option to continue into a six month, open-label phase during which time all subjects will receive the AndroGel patch.
Detailed description
We will recruit 100 men between the ages of 30 and 65 years who have treatment-refractory depression and low or borderline low testosterone levels for participation in this study. For a period of nine weeks subjects will receive double-blind treatment with either AndroGel (testosterone gel) or placebo. During this double-blind treatment phase subjects will come to McLean Hospital for a total of seven visits. Both clinical assessments (including ratings of your levels of depression and anxiety, quality of life, and visuospatial memory)and laboratory tests will be performed at these visits. Following the nine week, double-blind phase, eligible subjects may enter into a six month, open-label treatment phase in which all subject receive AndroGel. If you participate in the open-label phase, you will be asked to return to the site for 8 visits during the six month period.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| testosterone gel | Active comparator | Drug: Testosterone gelAndroGel (1% testosterone transdermal gel), 2.5 g to 10 g daily |
| placebo gel | Placebo comparator | Drug: PlaceboPlacebo gel |
Who may qualify
- Ages
- 30 to 65 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Male
- 30-65 years old
- Taking at least one serotonergic antidepressant at adequate dose for at least six weeks but still meeting DSM-IV criteria for major depressive disorder within the past year
- HAM-D score >12
Key exclusion criteria (7 listed)
- Current suicidal ideation
- Substance abuse or dependence within the past year
- Current or past psychotic symptoms
- A history of bipolar disorder
- A prostate-specific antigen (PSA) level greater than 4.0 ng/ml
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Testosterone gelAlso: AndroGelAndroGel 2.5g and 5g sachets at doses ranging from 10g/day for duration of trial. | Drug | testosterone gel |
| PlaceboPlacebo | Drug | placebo gel |
Primary outcome
21-item Hamilton Depression Rating Scale Score (HAM-D)
Time frame: 9 weeks (1-week placebo lead-in and 8 weeks of blinded medication treatment)
The HAM-D generates a score ranging from 0 (no depressive symptoms) to 64 (most severe depression).
1 secondary outcome
Montgomery Asberg Depression Rating Scale (MADRS)
Time frame: 9 weeks (1 week of placebo lead-in and 8 weeks of blinded medication treatment)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Nov 2010.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 20520285Pope HG Jr, Amiaz R, Brennan BP, Orr G, Weiser M, Kelly JF, Kanayama G, Siegel A, Hudson JI, Seidman SN. Parallel-group placebo-controlled trial of testosterone gel in men with major depressive disorder displaying an incomplete response to standard antidepressant treatment. J Clin Psychopharmacol. 2010 Apr;30(2):126-34. doi: 10.1097/JCP.0b013e3181d207ca.
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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.
Harrison G Pope, M.D. principal investigator
Mclean Hospital
Stuart N Seidman, M.D. principal investigator
Columbia University
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Testosterone gel in people with Depressive Disorder, Major, run by Mclean Hospital at 2 sites in 2 countries.
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 4 inclusion and 7 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 24 Nov 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States, Israel. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 17 Nov 2010). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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.
What does the primary outcome measure?
21-item Hamilton Depression Rating Scale Score (HAM-D) (time frame: 9 weeks (1-week placebo lead-in and 8 weeks of blinded medication treatment)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00304746, which also lists 1 linked publication.
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 24 Nov 2010.