DepressionNCT01783574

Testosterone Antidepressant Augmentation in Women

A study testing Testosterone in people with Depression, run by Massachusetts General Hospital at 2 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The investigators' hypotheses are: Low-dose testosterone augmentation improves depressive symptoms in women with Major Depressive Disorder (MDD) and antidepressant partial/nonresponse, adjunctive low-dose testosterone is safe and well-tolerated in women with MDD and antidepressant partial/nonresponse, and low-dose… Read more about this study

Who is it for?: Ages 21 to 75 years, women only
Conditions the study is for: Depression
What is being tested?: Testosterone
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 101 participants
Where: 2 sitesUnited States
Study dates: Aug 2013to 27 Jan 2017
Phase: Interventional
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 21 to 75 years
Women only
No healthy volunteers
Adult, Older adult

Who may be able to join

Female, age 21-75
Major depressive disorder including MADRS>/=12
Currently treated with an antidepressant monotherapy (1st, 2nd or 3rd trial in current episode), that has been taken at an adequate dose for at least six weeks.

Who cannot join

Serious suicide or homicide risk, as assessed by evaluating clinician
Unstable medical illness including cardiovascular, hepatic, renal, respiratory, endocrine, neurologic
Substance use disorder active within last six months, or clinical suspicion of ongoing substance use disorder at the discretion of the study clinician at time of screening based on history and/or laboratory results.
Any history of psychotic features, bipolar disorder, or primary obsessive compulsive disorder, as assessed by SCID
Currently treated with typical or atypical antipsychotic medications, or lithium
Untreated hypothyroidism. If treated hypothyroidism, change in levothyroxine dose within the prior 3 mos

Show all 11Show fewer

Use of androgens, including testosterone, dehydroepiandrosterone (DHEA) and methyltestosterone, within the prior three months
Any investigational psychotropic drug within the last thirty days
In the judgment of the study clinician, unlikely to be able to participate safely throughout the study period (three or more episodes of self-harm in the past year, documented history of poor treatment adherence, or frequent missed appointments (>50%) in the past year)
ALT > 3x upper limit of normal or creatinine> 3x upper limit
History of a hormone-responsive cancer

Trial locations and contacts

2 sites in 1 country.

United States2 sites

Massachusetts General Hospital
Boston, Massachusetts, 02114
Butler Hospital
Providence, Rhode Island, 02906

Other trials in United States

About this study

Official title: Collaborative Study: Testosterone Antidepressant Augmentation in Women

Conditions: Depression
Being tested: Testosterone, Placebo
Keywords: Depression, Major Depressive Disorder (MDD)
Medical subject headings: Depression, Depressive Disorder, Major

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

TestosteroneDrug
Also called AndroFeme 1(testosterone 1% w/v cream)
PlaceboDrug

Study groups in NCT01783574
Study group	Role	What they receive
Testosterone	Active comparator	Testosterone cream will be applied to skin for 8 weeks. Starting dose is 10 mg daily and will be titrated based on blood levels. Receives: Drug: Testosterone
Placebo	Placebo comparator	Placebo cream will appear identical to the testosterone cream and will be applied to skin for 8 weeks. Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

Depressive Symptom Severity
Montgomery-Asberg Depression Rating Score (MADRS) Score: This scale measures depression symptom severity. Higher scores indicate more severe depression symptom severity. The score range is 0-60 units on a scale.
Measured: Week 8

Secondary outcomes (2)

Fatigue
Brief Fatigue Inventory: This inventory measures fatigue severity. Higher scores indicate more severe fatigue. The range is 0-10 units on a scale.
Measured: Week 8
Sexual Dysfunction
Derogatis Interview of Sexual Function (Total Score): This scale measures sexual function. Lower scores indicate worse sexual function. The score range for this questionnaire is 0-160.
Measured: Week 8

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Aug 201327 Jan 2017

First posted5 Feb 2013 (estimated)
Study startAug 2013
Primary completion27 Jan 2017
Study completion27 Jan 2017

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 DepressionStudies of the same condition, open and under way.
More trials run by Massachusetts General HospitalThe 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: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 101 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01783574
Sponsor's protocol ID: 2012D000537
Other IDs: R34MH09931501A1
Status last verified: May 2018
First submitted: 1 Feb 2013
Last updated: 6 Jun 2018
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Publications

Dichtel LE, Carpenter LL, Nyer M, Mischoulon D, Kimball A, Deckersbach T, Dougherty DD, Schoenfeld DA, Fisher L, Cusin C, Dording C, Trinh NH, Pedrelli P, Yeung A, Farabaugh A, Papakostas GI, Chang T, Shapero BG, Chen J, Cassano P, Hahn EM, Rao EM, Brady RO Jr, Singh RJ, Tyrka AR, Price LH, Fava M, Miller KK. Low-Dose Testosterone Augmentation for Antidepressant-Resistant Major Depressive Disorder in Women: An 8-Week Randomized Placebo-Controlled Study. Am J Psychiatry. 2020 Oct 1;177(10):965-973. doi: 10.1176/appi.ajp.2020.19080844. Epub 2020 Jul 14.
PubMed 32660299

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 6 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Collaborative Study: Testosterone Antidepressant Augmentation in Women
ClinicalTrials.gov ID: NCT01783574
Acronym / sponsor ID: 2012D000537
Conditions: Depression
Keywords: Depression, Major Depressive Disorder (MDD)
Study type: Interventional
Recruitment status: Completed
Enrolment: 101 participants (actual)
Lead sponsor: Massachusetts General HospitalUniversity, hospital or other
Collaborators: National Institutes of Health (NIH), Lawley Pharmaceuticals
Study start: Aug 2013 (actual)
Primary completion: 27 Jan 2017 (actual)
Study completion: 27 Jan 2017 (actual)
First posted: 5 Feb 2013 (estimated)
Results: Posted 5 Apr 2018

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 2

Arm	Type	Receives
Testosterone	Active comparator	Drug: TestosteroneTestosterone cream will be applied to skin for 8 weeks. Starting dose is 10 mg daily and will be titrated based on blood levels.
Placebo	Placebo comparator	Drug: PlaceboPlacebo cream will appear identical to the testosterone cream and will be applied to skin for 8 weeks.

Who may qualify

Ages: 21 to 75 years
Sex: Female only
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

Female, age 21-75
Major depressive disorder including MADRS>/=12
Currently treated with an antidepressant monotherapy (1st, 2nd or 3rd trial in current episode), that has been taken at an adequate dose for at least six weeks.

Key exclusion criteria (11 listed)

Serious suicide or homicide risk, as assessed by evaluating clinician
Unstable medical illness including cardiovascular, hepatic, renal, respiratory, endocrine, neurologic
Substance use disorder active within last six months, or clinical suspicion of ongoing substance use disorder at the discretion of the study clinician at time of screening based on history and/or laboratory results.
Any history of psychotic features, bipolar disorder, or primary obsessive compulsive disorder, as assessed by SCID
Currently treated with typical or atypical antipsychotic medications, or lithium

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
TestosteroneAlso: AndroFeme 1(testosterone 1% w/v cream)	Drug	Testosterone
Placebo	Drug	Placebo

Primary outcome

Depressive Symptom Severity
Time frame: Week 8
Montgomery-Asberg Depression Rating Score (MADRS) Score: This scale measures depression symptom severity. Higher scores indicate more severe depression symptom severity. The score range is 0-60 units on a scale.

2 secondary outcomes

Fatigue
Time frame: Week 8
Sexual Dysfunction
Time frame: Week 8

Results and safety

Results posted to the registry on 5 Apr 2018, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Testosterone	51	46
Placebo	50	41

Primary outcome: Depressive Symptom Severity

Time frame: Week 8. Mean (Standard Error). Unit: units on a scale

Measure	Testosterone n = 51	Placebo n = 50
Value	15.3 (1.4)	14.1 (1.4)

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: 8 weeks. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Testosterone	0 of 51 (0%)	15 of 51 (29.4%)	0 of 51
Placebo	0 of 50 (0%)	13 of 50 (26%)	0 of 50

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 6 Jun 2018.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 32660299Dichtel LE, Carpenter LL, Nyer M, Mischoulon D, Kimball A, Deckersbach T, Dougherty DD, Schoenfeld DA, Fisher L, Cusin C, Dording C, Trinh NH, Pedrelli P, Yeung A, Farabaugh A, Papakostas GI, Chang T, Shapero BG, Chen J, Cassano P, Hahn EM, Rao EM, Brady RO Jr, Singh RJ, Tyrka AR, Price LH, Fava M, Miller KK. Low-Dose Testosterone Augmentation for Antidepressant-Resistant Major Depressive Disorder in Women: An 8-Week Randomized Placebo-Controlled Study. Am J Psychiatry. 2020 Oct 1;177(10):965-973. doi: 10.1176/appi.ajp.2020.19080844. Epub 2020 Jul 14.

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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.

Karen Miller, MD principal investigator

Massachusetts General Hospital

Maurizio Fava, MD principal investigator

Massachusetts General Hospital

Linda L Carpenter, MD principal investigator

Butler Hospital

2 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Testosterone in people with Depression, run by Massachusetts General Hospital at 2 sites in United States.

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 3 inclusion and 11 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 6 Jun 2018. 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. 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.

Are results available for this study?

Yes. Results are posted in the registry (first posted 5 Apr 2018). 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?

Depressive Symptom Severity (time frame: Week 8). 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 NCT01783574, 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 6 Jun 2018.