Major Depressive DisorderNCT02176408
Efficacy of Adjunctive Exercise for the Behavioral Treatment of Major Depression
A study testing Behavioral Activation, Exercise Intervention and Stretching Intervention in people with Major Depressive Disorder, run by Boston University Charles River Campus at 1 site in United States.
Trial summary
Major depressive disorder (MDD) is the leading cause of disability in the developed world and is associated with lost productivity, increased health care utilization, and mortality. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Major Depressive Disorder
- What is being tested?
- Behavioral Activation, Exercise Intervention and Stretching Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2014to Aug 2016
- 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Males and females ages 18-65 with a principal DSM-5 diagnosis of MDD or Persistent Depressive Disorder with a current Major Depressive Episode (as determined by the Anxiety and Related Disorders Interview Schedule-5)
- Sedentary (moderate-intensity exercise less than two days per week for at least 30 minutes each time for at least 3 months)
- Able to provide informed consent for the study
- Sufficient command of the English language
Who cannot join
- Current or past psychotic disorders of any type, bipolar disorder (I, II, or NOS), schizophrenia or schizoaffective disorder, anorexia, bulimia, or alcohol or drug dependence
- Currently suicidal or high suicide risk (as evaluated by the Columbia Suicide Severity Rating Scale and BDI suicide item)
- Risk for exercise according to the Physical Activity Readiness Questionnaire (PAR-Q) in accordance with the guidelines set forth by the American College of Sports Medicine (ACSM) (i.e., existence of the conditions in the next bullet point)
- Physical conditions (e.g.,heart conditions, diabetes, asthma or another lung disease, bone/joint problems, or seizure disorder) interfering with the ability to exercise safely
- Individuals who have participated in cognitive behavioral therapy (CBT) directed towards the treatment of a mood disorder within three months of baseline, those simultaneously participating in another psychosocial treatment (other than supportive therapy) or those not currently stable (i.e., same dosage for at least 8 weeks) on psychotropic medications
- Women who are currently pregnant, plan to be pregnant in the next year, or currently breastfeeding
Trial locations and contacts
1 site in 1 country.
About this study
Major depressive disorder (MDD) is the leading cause of disability in the developed world and is associated with lost productivity, increased health care utilization, and mortality. Several empirically supported treatments, such as antidepressant medication and cognitive behavioral therapy, exist for the treatment of MDD; however, studies have shown that as many as 34% of individuals do not respond to these treatments. Exercise and stretching interventions represent alternative strategies associated with strong effect sizes in past studies. Additionally, exercise has been shown to enhance cognitive functioning, especially attention and memory. This study aims to investigate the effect of a combined aerobic exercise and behavioral activation treatment (BA) for MDD. Behavioral activation treatment involves completing both pleasant and mastery-based activities with the goal of enhancing mood. The current study will recruit 32 MDD patients for an active treatment phase of nine 60-90 minute sessions (6 weekly sessions and 3 biweekly sessions) of either BA plus exercise (BA+EX) or BA plus stretching (BA+STR). The purpose of this study is to identify if adding aerobic exercise to a brief psychosocial treatment can improve mood above and beyond an active control condition.
Read the detailed description
Individuals with major depressive disorder (MDD) will be recruited to participate in a free treatment trial of a combined exercise or stretching regimen plus behavioral activation treatment. All individuals will receive 6 weekly and 3 biweekly 1-hour sessions of behavioral activation treatment. Behavioral activation involves exploring values in different life areas (relationships, education/career, interests, etc.) and scheduling activities in line with these values. Research has shown that behavioral activation treatment can improve mood and alleviate depressive symptoms.
In addition, participants will be randomized (like a flip of a coin) to either an additional aerobic exercise intervention or an additional stretching intervention. These interventions will take place for half an hour after the first 6 weeks of the behavioral activation intervention. The purpose of this study is to examine if adding an aerobic exercise intervention to a brief psychosocial treatment can improve mood above and beyond an active control condition.
Throughout the study, participants will complete computer, questionnaire, and interview assessments as well as exercise tests and a blood draw. The details of each visit are listed below. For full completion of this study, participants can earn up to $100.
Screening visit: diagnostic interview, assessment for physical activity risk (brief meeting with physician)
Baseline visit (week 0): submaximal exercise test, blood draw, questionnaire measures, computer tests
Treatment visit 1 (week 1): BA treatment + EX/STR intervention, brief questionnaires
Treatment visit 2 (week 2): BA treatment + EX/STR intervention, brief questionnaires
Treatment visit 3 (week 3): BA treatment + EX/STR intervention, brief questionnaires
Treatment visit 4 (week 4): BA treatment + EX/STR intervention, questionnaires, submaximal exercise test, blood draw
Treatment visit 5 (week 5): BA treatment + EX/STR intervention, brief questionnaires
Treatment visit 6 (week 6): BA treatment + EX/STR intervention, brief questionnaires
Treatment visit 7 (week 8): BA treatment, questionnaires, submaximal exercise test, blood draw
Treatment visit 8 (week 10): BA treatment, brief questionnaires
Treatment visit 9 (week 12): BA treatment, questionnaire measures
Final assessment (week 16): submaximal exercise test, blood draw, questionnaire measures, computer tests
- Conditions
- Major Depressive Disorder
- Being tested
- Behavioral Activation, Exercise Intervention, Stretching Intervention
- Keywords
- Major Depressive Disorder, Depression, MDD, Exercise, Physical Activity, Treatment, Behavioral Activation
- Medical subject headings
- Depressive Disorder, Major, Depression, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Behavioral ActivationBehavioural
Behavioral Activation Therapy (BA). All participants will receive a standard behavioral activation treatment based on the manualized treatment described by Lejuez et al., 2011. Treatment will be delivered in 60-minute weekly sessions over a 6-week period followed by 3 biweekly booster sessions. Behavioral activation includes scheduling activities the patient will enjoy and find important with the purpose of improving mood.
Exercise InterventionBehavioural
Exercise Intervention (EX). The exercise intervention will immediately follow each of the first six weekly BA sessions. Each EX session will comprise 30 minutes of either providing rationale for the program or reviewing the previous week's progress. As part of the intervention, participants will be asked to perform 40 minutes of aerobic exercise at 60-75% of maximum heart rate on three days each week, with 5 minute stretching warm up and cool down. We will help all participants initiate and plan their at-home program of exercise.
Stretching InterventionBehavioural
Stretching Intervention (STR). The stretching intervention will also follow each of the first six weekly BA sessions. These sessions will comprise 30 minutes of providing rationale for the stretching program or reviewing the previous week's progress. As part of the intervention, participants will be asked to perform 50 minutes of stretching on three days each week. Participants in this condition will be provided with a 50-minute DVD of stretching exercises and will work with the therapist to plan their at-home stretching exercises.
| Study group | Role | What they receive |
|---|---|---|
| Behavioral Activation plus Exercise | Experimental | Six weekly 60-minute sessions plus three 60-minute biweekly booster sessions of behavioral activation treatment
Six weekly 30-minute sessions of the exercise intervention (with this intervention incorporated into the 60 minutes of the biweekly booster sessions) Receives: Behavioral: Behavioral Activation; Behavioral: Exercise Intervention |
| Behavioral Activation plus Stretching | Active comparator | Six weekly 60-minute sessions plus three 60-minute biweekly booster sessions of behavioral activation treatment
Six weekly 30-minute sessions of the stretching intervention (with this intervention incorporated into the 60 minutes of the biweekly booster sessions) Receives: Behavioral: Behavioral Activation; Behavioral: Stretching Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Montgomery-Asberg Depression Rating Scale (MADRS)
The MADRS is a 10-item clinician-rated measure of correlates of depression. Specifically, this questionnaire measures the following: sadness, tension, sleep, appetite, concentration, lassitude, numbness, pessimism, and suicidal ideation. The scale ranges from 0-60 with higher totals indicating worse depression. The following are norms for severity: 0 to 6 - normal/symptom absent; 7 to 19 - mild depression; 20 to 34 - moderate depression; and >34 - severe depression.
Measured: Week 16
Secondary outcomes (7)
Beck Depression Inventory-II (BDI-II)
The BDI is a widely used 21-item, self-report inventory designed to measure severity of depressive symptoms. Scores range from 0-63 with higher scores indicating worse depression. The following are severity norms for the measure: 0-13: minimal depression; 14-19: mild depression; 20-28: moderate depression; and 29-63: severe depression.
Measured: Week 16
Work and Social Adjustment Scale (WSAS)
The WSAS is a self-report scale of functional impairment attributable to an identified problem, in this case MDD. Scores range from 0 to 40 with higher scores indicating worse functioning. A WSAS score above 20 appears to suggest moderately severe or worse psychopathology. Scores between 10 and 20 are associated with significant functional impairment but less severe clinicalsymptomatology. Scores below 10 appear to be associated with subclinical populations.
Measured: Week 16
Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q)
The Q-LES-Q rates 16 aspects of quality of life, including physical health, mood, activities of daily living, and overall life satisfaction. Scores range from 14 to 70 with lower scores indicating worse quality of life.
Measured: Week 16
Logical Memory
Participants will be read a story and asked to remember as many details as possible. Raw scores are reported with a range in the current sample from from 17 to 47 with higher scores indicating better memory performance.
Measured: Week 16
Continuous Performance Test- Identical Pairs
Participants' attention will be assessed using the CPT which is a choice reaction time task which requires a subject to respond whenever two identical stimuli appear in a row within a sequence of rapidly flashed trials. Scores represent the average d' across 2 digit, 3 digit, and 4 digit trials. Average scores in this sample ranged from 1.76 to 4.24. Lower d' represents a better score.
Measured: Week 16
7 Day Physical Activity Recall (PAR)
The PAR is is an interviewer-administered measure of physical activity behavior that will be used as a self-report validation measure of amount of physical activity completed. Metabolic equivalents (METs) of moderate and vigorous intensity activity are reported. METs of activity ranged from 0 to 1520 in this sample with higher numbers indicating more physical activity completed.
Measured: Week 16
Brain-derived Neurotrophic Factor (BDNF)
Blood samples (approximately 1 tsp) will be collected at baseline, week 4, week 8, and week 16 to test serum BDNF. Changes in resting BDNF levels were assessed. BDNF levels ranged from 14391 to 43020 ng/ml in this sample with higher levels indicating more BDNF.
Measured: Week 16
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2014 (estimated)
- Study startJun 2014
- Primary completionAug 2016
- Study completionAug 2016
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 (2)Papers the sponsor has linked to this study.
- Other trials for Major Depressive DisorderStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boston University Charles River Campus
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Sponsor
- Investigators
- Kristin Szuhany, M.A., Principal investigator, Boston University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02176408
- Sponsor's protocol ID
- F31MH100773-01A1
- Other IDs
- F31MH100773-01A1
- Status last verified
- Aug 2019
- First submitted
- 24 Jun 2014
- Last updated
- 10 Sep 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Szuhany KL, Otto MW. Assessing BDNF as a mediator of the effects of exercise on depression. J Psychiatr Res. 2020 Apr;123:114-118. doi: 10.1016/j.jpsychires.2020.02.003. Epub 2020 Feb 8.
PubMed 32065946Szuhany KL, Otto MW. Efficacy evaluation of exercise as an augmentation strategy to brief behavioral activation treatment for depression: a randomized pilot trial. Cogn Behav Ther. 2020 May;49(3):228-241. doi: 10.1080/16506073.2019.1641145. Epub 2019 Jul 30.
PubMed 31357916
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Adjunctive Exercise for the Behavioral Treatment of Major Depression
- ClinicalTrials.gov ID
- NCT02176408
- Acronym / sponsor ID
- F31MH100773-01A1
- Conditions
- Major Depressive Disorder
- Keywords
- Major Depressive Disorder, Depression, MDD, Exercise, Physical Activity, Treatment, Behavioral Activation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- Boston University Charles River CampusUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- Jun 2014 (actual)
- Primary completion
- Aug 2016 (actual)
- Study completion
- Aug 2016 (actual)
- First posted
- 27 Jun 2014 (estimated)
- Results
- Posted 10 Sep 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Major depressive disorder (MDD) is the leading cause of disability in the developed world and is associated with lost productivity, increased health care utilization, and mortality. Several empirically supported treatments, such as antidepressant medication and cognitive behavioral therapy, exist for the treatment of MDD; however, studies have shown that as many as 34% of individuals do not respond to these treatments. Exercise and stretching interventions represent alternative strategies associated with strong effect sizes in past studies. Additionally, exercise has been shown to enhance cognitive functioning, especially attention and memory. This study aims to investigate the effect of a combined aerobic exercise and behavioral activation treatment (BA) for MDD. Behavioral activation treatment involves completing both pleasant and mastery-based activities with the goal of enhancing mood. The current study will recruit 32 MDD patients for an active treatment phase of nine 60-90 minute sessions (6 weekly sessions and 3 biweekly sessions) of either BA plus exercise (BA+EX) or BA plus stretching (BA+STR). The purpose of this study is to identify if adding aerobic exercise to a brief psychosocial treatment can improve mood above and beyond an active control condition.
Detailed description
Individuals with major depressive disorder (MDD) will be recruited to participate in a free treatment trial of a combined exercise or stretching regimen plus behavioral activation treatment. All individuals will receive 6 weekly and 3 biweekly 1-hour sessions of behavioral activation treatment. Behavioral activation involves exploring values in different life areas (relationships, education/career, interests, etc.) and scheduling activities in line with these values. Research has shown that behavioral activation treatment can improve mood and alleviate depressive symptoms.
In addition, participants will be randomized (like a flip of a coin) to either an additional aerobic exercise intervention or an additional stretching intervention. These interventions will take place for half an hour after the first 6 weeks of the behavioral activation intervention. The purpose of this study is to examine if adding an aerobic exercise intervention to a brief psychosocial treatment can improve mood above and beyond an active control condition.
Throughout the study, participants will complete computer, questionnaire, and interview assessments as well as exercise tests and a blood draw. The details of each visit are listed below. For full completion of this study, participants can earn up to $100.
Screening visit: diagnostic interview, assessment for physical activity risk (brief meeting with physician)
Baseline visit (week 0): submaximal exercise test, blood draw, questionnaire measures, computer tests
Treatment visit 1 (week 1): BA treatment + EX/STR intervention, brief questionnaires
Treatment visit 2 (week 2): BA treatment + EX/STR intervention, brief questionnaires
Treatment visit 3 (week 3): BA treatment + EX/STR intervention, brief questionnaires
Treatment visit 4 (week 4): BA treatment + EX/STR intervention, questionnaires, submaximal exercise test, blood draw
Treatment visit 5 (week 5): BA treatment + EX/STR intervention, brief questionnaires
Treatment visit 6 (week 6): BA treatment + EX/STR intervention, brief questionnaires
Treatment visit 7 (week 8): BA treatment, questionnaires, submaximal exercise test, blood draw
Treatment visit 8 (week 10): BA treatment, brief questionnaires
Treatment visit 9 (week 12): BA treatment, questionnaire measures
Final assessment (week 16): submaximal exercise test, blood draw, questionnaire measures, computer tests
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Behavioral Activation plus Exercise | Experimental | Behavioral: Behavioral Activation, Behavioral: Exercise InterventionSix weekly 60-minute sessions plus three 60-minute biweekly booster sessions of behavioral activation treatment Six weekly 30-minute sessions of the exercise intervention (with this intervention incorporated into the 60 minutes of the biweekly booster sessions) |
| Behavioral Activation plus Stretching | Active comparator | Behavioral: Behavioral Activation, Behavioral: Stretching InterventionSix weekly 60-minute sessions plus three 60-minute biweekly booster sessions of behavioral activation treatment Six weekly 30-minute sessions of the stretching intervention (with this intervention incorporated into the 60 minutes of the biweekly booster sessions) |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Males and females ages 18-65 with a principal DSM-5 diagnosis of MDD or Persistent Depressive Disorder with a current Major Depressive Episode (as determined by the Anxiety and Related Disorders Interview Schedule-5)
- Sedentary (moderate-intensity exercise less than two days per week for at least 30 minutes each time for at least 3 months)
- Able to provide informed consent for the study
- Sufficient command of the English language
Key exclusion criteria (6 listed)
- Current or past psychotic disorders of any type, bipolar disorder (I, II, or NOS), schizophrenia or schizoaffective disorder, anorexia, bulimia, or alcohol or drug dependence
- Currently suicidal or high suicide risk (as evaluated by the Columbia Suicide Severity Rating Scale and BDI suicide item)
- Risk for exercise according to the Physical Activity Readiness Questionnaire (PAR-Q) in accordance with the guidelines set forth by the American College of Sports Medicine (ACSM) (i.e., existence of the conditions in the next bullet point)
- Physical conditions (e.g.,heart conditions, diabetes, asthma or another lung disease, bone/joint problems, or seizure disorder) interfering with the ability to exercise safely
- Individuals who have participated in cognitive behavioral therapy (CBT) directed towards the treatment of a mood disorder within three months of baseline, those simultaneously participating in another psychosocial treatment (other than supportive therapy) or those not currently stable (i.e., same dosage for at least 8 weeks) on psychotropic medications
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 |
|---|---|---|
| Behavioral ActivationBehavioral Activation Therapy (BA). All participants will receive a standard behavioral activation treatment based on the manualized treatment described by Lejuez et al., 2011. Treatment will be delivered in 60-minute weekly sessions over a 6-week period followed by 3 biweekly booster sessions. Behavioral activation includes scheduling activities the patient will enjoy and find important with the purpose of improving mood. | Behavioural | Behavioral Activation plus Exercise, Behavioral Activation plus Stretching |
| Exercise InterventionExercise Intervention (EX). The exercise intervention will immediately follow each of the first six weekly BA sessions. Each EX session will comprise 30 minutes of either providing rationale for the program or reviewing the previous week's progress. As part of the intervention, participants will be asked to perform 40 minutes of aerobic exercise at 60-75% of maximum heart rate on three days each week, with 5 minute stretching warm up and cool down. We will help all participants initiate and plan their at-home program of exercise. | Behavioural | Behavioral Activation plus Exercise |
| Stretching InterventionStretching Intervention (STR). The stretching intervention will also follow each of the first six weekly BA sessions. These sessions will comprise 30 minutes of providing rationale for the stretching program or reviewing the previous week's progress. As part of the intervention, participants will be asked to perform 50 minutes of stretching on three days each week. Participants in this condition will be provided with a 50-minute DVD of stretching exercises and will work with the therapist to plan their at-home stretching exercises. | Behavioural | Behavioral Activation plus Stretching |
Primary outcome
Montgomery-Asberg Depression Rating Scale (MADRS)
Time frame: Week 16
The MADRS is a 10-item clinician-rated measure of correlates of depression. Specifically, this questionnaire measures the following: sadness, tension, sleep, appetite, concentration, lassitude, numbness, pessimism, and suicidal ideation. The scale ranges from 0-60 with higher totals indicating worse depression. The following are norms for severity: 0 to 6 - normal/symptom absent; 7 to 19 - mild depression; 20 to 34 - moderate depression; and >34 - severe depression.
7 secondary outcomes
Beck Depression Inventory-II (BDI-II)
Time frame: Week 16
Work and Social Adjustment Scale (WSAS)
Time frame: Week 16
Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q)
Time frame: Week 16
Logical Memory
Time frame: Week 16
Continuous Performance Test- Identical Pairs
Time frame: Week 16
7 Day Physical Activity Recall (PAR)
Time frame: Week 16
Brain-derived Neurotrophic Factor (BDNF)
Time frame: Week 16
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Sep 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 32065946Szuhany KL, Otto MW. Assessing BDNF as a mediator of the effects of exercise on depression. J Psychiatr Res. 2020 Apr;123:114-118. doi: 10.1016/j.jpsychires.2020.02.003. Epub 2020 Feb 8.
- Derived from this study: PubMed 31357916Szuhany KL, Otto MW. Efficacy evaluation of exercise as an augmentation strategy to brief behavioral activation treatment for depression: a randomized pilot trial. Cogn Behav Ther. 2020 May;49(3):228-241. doi: 10.1080/16506073.2019.1641145. Epub 2019 Jul 30.
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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.
Kristin Szuhany, M.A. principal investigator
Boston University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Behavioral Activation, Exercise Intervention and Stretching Intervention in people with Major Depressive Disorder, run by Boston University Charles River Campus 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 4 inclusion and 6 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 10 Sep 2019. 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?
Yes. Results are posted in the registry (first posted 10 Sep 2019). 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?
Montgomery-Asberg Depression Rating Scale (MADRS) (time frame: Week 16). 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 NCT02176408, which also lists 2 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 10 Sep 2019.