DepressionPRO-SHARENCT01641263
Promoting Sleep and Healthy Aging Research Study (PRO-SHARE)
A study testing Sleep Education Therapy and Cognitve Behavioral Therapy for Insomnia in people with Depression, run by University of California, Los Angeles at 1 site in United States.
Trial summary
The objective of this study is to evaluate the ability of a behavioral intervention, cognitive behavioral therapy for sleep quality (CBT-SQ) to reduce sleep complaints, depression recurrence, and cellular and genomic markers of inflammation in older adults with sleep complaints who have a prior history of depression. Read more about this study
- Who is it for?
- Ages 60 years and olderHealthy volunteers can take part
- Conditions the study is for
- Depression
- What is being tested?
- Sleep Education Therapy and Cognitve Behavioral Therapy for Insomnia
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 308 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2012to Jul 2018
- Phase
- Interventional
- 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 60 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Older adults >= 60 year of age
- Evidence of self-reported sleep disturbance as indexed by PSQI scores >5.
Who cannot join
- Psychiatric Disorders.
- current major depressive disorder or other DSM-IV psychiatric disorder (e.g. substance dependence) with the exception of a anxiety disorder;
- presence of psychotic symptoms
- acute suicidal or violent behavior or history of suicide attempt within the last year;
- Sleep Disorders.
- current or lifetime history of sleep disorder (sleep apnea, nocturnal myoclonus, phase-shift disorder) as identified by SCID-IV and the Duke Structured Interview for Sleep Disorders (DSISD); persons with co-morbid insomnia will be included
Show all 16Show fewer
- Medical conditions.
- severe or acute medical illness (e.g., major surgery, metastatic cancer, stroke, or myocardial infarction) six months prior to study entry presence of co-morbid medical conditions; 5) neurological diseases (e.g., Parkinson's diseases, multiple sclerosis; neurodegenerative dementia,);
- severe pain disorders requiring daily pain management;
- presence of co-morbid inflammatory disorders such as rheumatoid arthritis and other autoimmune disorders that would confound the assessment of sleep as well as inflammatory markers;
- presence of uncontrolled medical condition that is deemed by the investigators to interfere with the proposed study procedures, or put the study participant at undue risk (e.g., an active heart failure categorized as Class III or greater according to New York Heart Association criteria; symptomatic cardiac arrhythmias; symptomatic, hemodynamically significant mitral or aortic valvular disease);
- presence of chronic infections, which may elevate proinflammatory cytokines. While we will not exclude this individuals only behavioral outcomes will be measured on these subjects. No analysis of blood will be performed. (If a history of an acute infectious illness is identified within two weeks of a scheduled blood sampling, the session will be rescheduled to occur outside this two week period);
- Medication and substance use.
- use of hormone containing medications including steroids;
- immune modifying drugs that target specific immune responses agents such as TNF antagonists;
- daily use of analgesics such as opioids. We will include those taking psychotropic medications (except for anti-psychotic medications or who have have been treated with a depot-neuroleptic within 6 months prior to study entry) In regards to psychotropic medication use, we will quantify past, current, and ongoing use of psychotropic medications (e.g., selective serotonin reuptake inhibitors, other antidepressants, anxiolytics, hypnotics, sedatives) and assess the effects of these medications on primary outcomes during the intervention, and follow-up period.
Trial locations and contacts
1 site in 1 country.
United States1 site
UCLA Cousins Center for Psychoneuroimmunology
Los Angeles, California, 90095
About this study
Official title: Aging: Sleep and Inflammatory Mechanism in Depression Prevention
The objective of this study is to evaluate the ability of a behavioral intervention, cognitive behavioral therapy for sleep quality (CBT-SQ) to reduce sleep complaints, depression recurrence, and cellular and genomic markers of inflammation in older adults with sleep complaints who have a prior history of depression. The investigators aim to: 1) evaluate the effects of CBT-SQ vs. Sleep Seminar (SS) on objective (actigraphy) and subjective (sleep diary; questionnaire) measures of sleep symptoms over a two-year follow-up; 2) determine the effects of CBT-SQ vs. SS on recurrence of depressive symptoms and depression episode(s) over a two-year follow-up. The investigators will also secondarily examine the effects of CBT-SQ vs. SS on cellular and genomic markers of inflammation over a two-year follow-up, and explore whether markers of inflammation and cytokine genes can explain variability in the risk of depression recurrence in those older adults receiving CBT-SQ vs. SS. The present study is highly significant by being the first study, to the investigators knowledge, to focus on the prevention of depression in community dwelling older adults who have a history of depression, and by targeting sleep disturbance, a modifiable risk factor to prevent depression recurrence.
Read the detailed description
Depression, one of the most common diseases in older adults, carries significant risk for morbidity, and mortality. However, many older adults with depression are not identified and even when identified, they face protracted courses of treatment, with over 60% of elderly patients failing to achieve symptomatic remission. Given the burgeoning population of older adults, as well as the enormous burden of depression, efforts to maximize depression prevention are needed.
Despite advances in understanding the behavioral pathways that contribute to depression, there has been little attention aimed at targeting behavioral risk factors such as sleep disturbance, even though such strategies have the potential to optimize efficiency (i.e., decrease number needed to treat (NNT) among vulnerable older adults with a history of depression. In this study, we hypothesize that recognition and treatment of sleep disturbance, a modifiable behavioral risk factor, will prevent depression incidence in older adults. Whereas sleep disturbance in depressed patients often lingers and its persistence can represent a residual phase of a major mood disorder, emergence of disturbed sleep in non-depressed older adults serves as an independent risk factor depression that occurs later in life. In a 2-year prospective cohort study of community-dwelling older adults aged 60 years or older (N=351), we have found that sleep disturbance is prospectively associated with depression incidence independent of other current depressive symptoms, as well as antidepressant and hypnotic medication use, and medical status. To evaluate sleep disturbance at the community level, sleep disturbance was defined by a self-report measure (i.e. scores > 5 on the Pittsburgh Sleep Quality Index (PSQI), which highly correlates with insomnia diagnosis. We have found similar prospective results between reported sleep disturbance and depression in adults (N=1716).
Increasing evidence also implicates inflammation as a biological mechanism that contributes to depression, and we further hypothesize that increases in inflammation are associated with the link between sleep disturbance and depression incidence. Whereas multiple other factors including but not limited to, psychosocial stress, medical illness, obesity, sedentary lifestyle, social isolation, low socio-economic status, female sex, and smoking can drive inflammation and are associated with depression, our preliminary data have found that sleep disturbance induces activation of inflammatory signaling,and additional naturalistic and epidemiologic preliminary findings show that sleep disturbance is associated with increases in markers of inflammation especially among those with a history of depression. In turn, we and others have found that inflammation prospectively predicts depression recurrence in community dwelling adults who have a history of depression (N=1716)16 Although there is also evidence that this association can be reciprocal,33 our experimental preliminary data show that inflammatory activation induces depressed mood. In contrast, cognitive behavioral therapy for insomnia (CBT-I)) reduces cellular markers of inflammation in older adults who show a remission of clinical sleep complaints.
The over-arching objectives of this study are to evaluate the ability of CBT-I vs. an active comparator control, Sleep Education Therapy (SET) to reduce sleep complaints, depression incidence, and cellular and genomic markers of inflammation in older adults with self-reported sleep disturbance with follow-up up to three years.
- Conditions
- Depression
- Being tested
- Sleep Education Therapy, Cognitve Behavioral Therapy for Insomnia
- Keywords
- Depression Prevention, Sleep Disturbances, Inflammatory Markers, Treatments for Sleep Problems
- Medical subject headings
- Depression, Parasomnias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sleep Education TherapyBehavioural
Also called Sleep seminar
Each 2-hour session, held once a week for 8 weeks, consists of a 60-minute video presentation followed by a 60-minute question-and-answer discussion
Cognitve Behavioral Therapy for InsomniaBehavioural
Also called Cognitive Behavioral Therapy
For each 2-hour session held once a week for 8 weeks, the CBT treatment manual will outline objectives, patient skills, and treatment activities. Therapists will direct role-playing and other skill-development exercises that will be designed to increase patients' self-efficacy in managing their insomnia. Homework assignments will be planned weekly to ensure practice and skill application.
| Study group | Role | What they receive |
|---|---|---|
| Cognitive Behavioral Therapy | Experimental | For each 2-hour session held once a week for 8 weeks, the CBT treatment manual will outline objectives, patient skills, and treatment activities. Therapists will direct role-playing and other skill-development exercises that will be designed to increase patients' self-efficacy in managing their insomnia. Homework assignments will be planned weekly to ensure practice and skill application. Receives: Behavioral: Cognitve Behavioral Therapy for Insomnia |
| Sleep Seminar | Active comparator | Each 2-hour session, held once a week for 8 weeks, consists of a 60-minute video presentation followed by a 60-minute question-and-answer discussion Receives: Behavioral: Sleep Education Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in depression from baseline
Depressive symptom severity and depressive episodes.
Measured: Up to 3 years
Secondary outcomes (6)
Change in inflammation from baseline
Cellular and genomic markers of inflammation will be measured
Measured: Up to 3 years
Change in Health and Daily Function from baseline
The overall well-being and health function of individuals will be assessed with questionnaires.
Measured: Up to 3 years
Change in Mental Health from baseline
Additional questionnaires assements will be administered to determine the anxiety, worry and stress of the participants during the trial.
Measured: Up to 3 years
Change in Physical Activity from baseline
Physical activity will be determined with questionnaires.
Measured: Up to 3 years
Change in Social Function from baseline
The social function and social networks of the participants will be assesed during the course of the study.
Measured: Up to 3 years
Change in Sleep disturbance from baseline
Assessment of sleep by subjective report with evaluation of sleep by actigraphy in a selected subgroup
Measured: Up to 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2012 (estimated)
- Study startJul 2012
- Primary completionApr 2018
- Study completionJul 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for DepressionStudies of the same condition, open and under way.
- More trials run by University of California, Los AngelesThe 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 308 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Los Angeles
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Responsible party
- Principal investigator, Michael Irwin, MD, University of California, Los Angeles
- Investigators
- Michael R Irwin, MD, Principal investigator, University of California, Los Angeles
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01641263
- Sponsor's protocol ID
- NIA-RO1-AG026364
- Other IDs
- R01AG026364
- Acronym
- PRO-SHARE
- Status last verified
- Sep 2020
- First submitted
- 26 Jun 2012
- Last updated
- 30 Sep 2020
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Cho HJ, Lavretsky H, Olmstead R, Levin M, Oxman MN, Irwin MR. Prior depression history and deterioration of physical health in community-dwelling older adults--a prospective cohort study. Am J Geriatr Psychiatry. 2010 May;18(5):442-51. doi: 10.1097/JGP.0b013e3181ca3a2d.
PubMed 20220581Cho HJ, Lavretsky H, Olmstead R, Levin MJ, Oxman MN, Irwin MR. Sleep disturbance and depression recurrence in community-dwelling older adults: a prospective study. Am J Psychiatry. 2008 Dec;165(12):1543-50. doi: 10.1176/appi.ajp.2008.07121882. Epub 2008 Sep 2.
PubMed 18765482Meeks TW, Wetherell JL, Irwin MR, Redwine LS, Jeste DV. Complementary and alternative treatments for late-life depression, anxiety, and sleep disturbance: a review of randomized controlled trials. J Clin Psychiatry. 2007 Oct;68(10):1461-71. doi: 10.4088/jcp.v68n1001.
PubMed 17960959Carroll JE, Kusters CD, Taha HB, Olmstead R, Breen EC, Irwin MR. Cognitive behavioural therapy for insomnia and epigenetic ageing: secondary analysis from a randomised controlled trial. Lancet Healthy Longev. 2026 Aug 12:100861. doi: 10.1016/j.lanhl.2026.100861. Online ahead of print.
PubMed 42586102Bjurstrom MF, Olmstead R, Irwin MR. Insomnia remission and improvement of bodily pain in older adults: a randomized clinical trial. Pain Rep. 2025 Feb 5;10(2):e1243. doi: 10.1097/PR9.0000000000001243. eCollection 2025 Apr.
PubMed 39917321Irwin MR, Carrillo C, Sadeghi N, Bjurstrom MF, Breen EC, Olmstead R. Prevention of Incident and Recurrent Major Depression in Older Adults With Insomnia: A Randomized Clinical Trial. JAMA Psychiatry. 2022 Jan 1;79(1):33-41. doi: 10.1001/jamapsychiatry.2021.3422.
PubMed 34817561
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Aging: Sleep and Inflammatory Mechanism in Depression Prevention
- ClinicalTrials.gov ID
- NCT01641263
- Acronym / sponsor ID
- PRO-SHARE / NIA-RO1-AG026364
- Conditions
- Depression
- Keywords
- Depression Prevention, Sleep Disturbances, Inflammatory Markers, Treatments for Sleep Problems
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 308 participants (actual)
- Lead sponsor
- University of California, Los AngelesUniversity, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Study start
- Jul 2012
- Primary completion
- Apr 2018 (actual)
- Study completion
- Jul 2018 (actual)
- First posted
- 16 Jul 2012 (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.
The objective of this study is to evaluate the ability of a behavioral intervention, cognitive behavioral therapy for sleep quality (CBT-SQ) to reduce sleep complaints, depression recurrence, and cellular and genomic markers of inflammation in older adults with sleep complaints who have a prior history of depression. The investigators aim to: 1) evaluate the effects of CBT-SQ vs. Sleep Seminar (SS) on objective (actigraphy) and subjective (sleep diary; questionnaire) measures of sleep symptoms over a two-year follow-up; 2) determine the effects of CBT-SQ vs. SS on recurrence of depressive symptoms and depression episode(s) over a two-year follow-up. The investigators will also secondarily examine the effects of CBT-SQ vs. SS on cellular and genomic markers of inflammation over a two-year follow-up, and explore whether markers of inflammation and cytokine genes can explain variability in the risk of depression recurrence in those older adults receiving CBT-SQ vs. SS. The present study is highly significant by being the first study, to the investigators knowledge, to focus on the prevention of depression in community dwelling older adults who have a history of depression, and by targeting sleep disturbance, a modifiable risk factor to prevent depression recurrence.
Detailed description
Depression, one of the most common diseases in older adults, carries significant risk for morbidity, and mortality. However, many older adults with depression are not identified and even when identified, they face protracted courses of treatment, with over 60% of elderly patients failing to achieve symptomatic remission. Given the burgeoning population of older adults, as well as the enormous burden of depression, efforts to maximize depression prevention are needed.
Despite advances in understanding the behavioral pathways that contribute to depression, there has been little attention aimed at targeting behavioral risk factors such as sleep disturbance, even though such strategies have the potential to optimize efficiency (i.e., decrease number needed to treat (NNT) among vulnerable older adults with a history of depression. In this study, we hypothesize that recognition and treatment of sleep disturbance, a modifiable behavioral risk factor, will prevent depression incidence in older adults. Whereas sleep disturbance in depressed patients often lingers and its persistence can represent a residual phase of a major mood disorder, emergence of disturbed sleep in non-depressed older adults serves as an independent risk factor depression that occurs later in life. In a 2-year prospective cohort study of community-dwelling older adults aged 60 years or older (N=351), we have found that sleep disturbance is prospectively associated with depression incidence independent of other current depressive symptoms, as well as antidepressant and hypnotic medication use, and medical status. To evaluate sleep disturbance at the community level, sleep disturbance was defined by a self-report measure (i.e. scores > 5 on the Pittsburgh Sleep Quality Index (PSQI), which highly correlates with insomnia diagnosis. We have found similar prospective results between reported sleep disturbance and depression in adults (N=1716).
Increasing evidence also implicates inflammation as a biological mechanism that contributes to depression, and we further hypothesize that increases in inflammation are associated with the link between sleep disturbance and depression incidence. Whereas multiple other factors including but not limited to, psychosocial stress, medical illness, obesity, sedentary lifestyle, social isolation, low socio-economic status, female sex, and smoking can drive inflammation and are associated with depression, our preliminary data have found that sleep disturbance induces activation of inflammatory signaling,and additional naturalistic and epidemiologic preliminary findings show that sleep disturbance is associated with increases in markers of inflammation especially among those with a history of depression. In turn, we and others have found that inflammation prospectively predicts depression recurrence in community dwelling adults who have a history of depression (N=1716)16 Although there is also evidence that this association can be reciprocal,33 our experimental preliminary data show that inflammatory activation induces depressed mood. In contrast, cognitive behavioral therapy for insomnia (CBT-I)) reduces cellular markers of inflammation in older adults who show a remission of clinical sleep complaints.
The over-arching objectives of this study are to evaluate the ability of CBT-I vs. an active comparator control, Sleep Education Therapy (SET) to reduce sleep complaints, depression incidence, and cellular and genomic markers of inflammation in older adults with self-reported sleep disturbance with follow-up up to three years.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cognitive Behavioral Therapy | Experimental | Behavioral: Cognitve Behavioral Therapy for InsomniaFor each 2-hour session held once a week for 8 weeks, the CBT treatment manual will outline objectives, patient skills, and treatment activities. Therapists will direct role-playing and other skill-development exercises that will be designed to increase patients' self-efficacy in managing their insomnia. Homework assignments will be planned weekly to ensure practice and skill application. |
| Sleep Seminar | Active comparator | Behavioral: Sleep Education TherapyEach 2-hour session, held once a week for 8 weeks, consists of a 60-minute video presentation followed by a 60-minute question-and-answer discussion |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Older adults >= 60 year of age
- Evidence of self-reported sleep disturbance as indexed by PSQI scores >5.
Key exclusion criteria (16 listed)
- Psychiatric Disorders.
- current major depressive disorder or other DSM-IV psychiatric disorder (e.g. substance dependence) with the exception of a anxiety disorder;
- presence of psychotic symptoms
- acute suicidal or violent behavior or history of suicide attempt within the last year;
- Sleep Disorders.
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 |
|---|---|---|
| Sleep Education TherapyAlso: Sleep seminarEach 2-hour session, held once a week for 8 weeks, consists of a 60-minute video presentation followed by a 60-minute question-and-answer discussion | Behavioural | Sleep Seminar |
| Cognitve Behavioral Therapy for InsomniaAlso: Cognitive Behavioral TherapyFor each 2-hour session held once a week for 8 weeks, the CBT treatment manual will outline objectives, patient skills, and treatment activities. Therapists will direct role-playing and other skill-development exercises that will be designed to increase patients' self-efficacy in managing their insomnia. Homework assignments will be planned weekly to ensure practice and skill application. | Behavioural | Cognitive Behavioral Therapy |
Primary outcome
Change in depression from baseline
Time frame: Up to 3 years
Depressive symptom severity and depressive episodes.
6 secondary outcomes
Change in inflammation from baseline
Time frame: Up to 3 years
Change in Health and Daily Function from baseline
Time frame: Up to 3 years
Change in Mental Health from baseline
Time frame: Up to 3 years
Change in Physical Activity from baseline
Time frame: Up to 3 years
Change in Social Function from baseline
Time frame: Up to 3 years
Change in Sleep disturbance from baseline
Time frame: Up to 3 years
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 30 Sep 2020.
- Background: PubMed 20220581Cho HJ, Lavretsky H, Olmstead R, Levin M, Oxman MN, Irwin MR. Prior depression history and deterioration of physical health in community-dwelling older adults--a prospective cohort study. Am J Geriatr Psychiatry. 2010 May;18(5):442-51. doi: 10.1097/JGP.0b013e3181ca3a2d.
- Background: PubMed 18765482Cho HJ, Lavretsky H, Olmstead R, Levin MJ, Oxman MN, Irwin MR. Sleep disturbance and depression recurrence in community-dwelling older adults: a prospective study. Am J Psychiatry. 2008 Dec;165(12):1543-50. doi: 10.1176/appi.ajp.2008.07121882. Epub 2008 Sep 2.
- Background: PubMed 17960959Meeks TW, Wetherell JL, Irwin MR, Redwine LS, Jeste DV. Complementary and alternative treatments for late-life depression, anxiety, and sleep disturbance: a review of randomized controlled trials. J Clin Psychiatry. 2007 Oct;68(10):1461-71. doi: 10.4088/jcp.v68n1001.
- Derived from this study: PubMed 42586102Carroll JE, Kusters CD, Taha HB, Olmstead R, Breen EC, Irwin MR. Cognitive behavioural therapy for insomnia and epigenetic ageing: secondary analysis from a randomised controlled trial. Lancet Healthy Longev. 2026 Aug 12:100861. doi: 10.1016/j.lanhl.2026.100861. Online ahead of print.
- Derived from this study: PubMed 39917321Bjurstrom MF, Olmstead R, Irwin MR. Insomnia remission and improvement of bodily pain in older adults: a randomized clinical trial. Pain Rep. 2025 Feb 5;10(2):e1243. doi: 10.1097/PR9.0000000000001243. eCollection 2025 Apr.
- Derived from this study: PubMed 34817561Irwin MR, Carrillo C, Sadeghi N, Bjurstrom MF, Breen EC, Olmstead R. Prevention of Incident and Recurrent Major Depression in Older Adults With Insomnia: A Randomized Clinical Trial. JAMA Psychiatry. 2022 Jan 1;79(1):33-41. doi: 10.1001/jamapsychiatry.2021.3422.
- The UCLA Cousins Center WebsiteLink provided by the sponsor.
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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.
Michael R Irwin, MD principal investigator
University of California, Los Angeles
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sleep Education Therapy and Cognitve Behavioral Therapy for Insomnia in people with Depression, run by University of California, Los Angeles at 1 site 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 2 inclusion and 16 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 30 Sep 2020. 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 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. 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.
What does the primary outcome measure?
Change in depression from baseline (time frame: Up to 3 years). 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 NCT01641263, which also lists 6 linked publications.
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 30 Sep 2020.