Major Depressive DisorderNCT02685982
Treating Major Depressive Disorder With Music and Low-frequency Rhythmic Sensory Stimulation
A study testing Rhythmic Sensory Stimulation in people with Major Depressive Disorder, run by University Health Network, Toronto.
Trial summary
Major depressive disorder (MDD) is a highly prevalent and disabling disorder associated with persistent low mood, loss of the capacity to experience pleasure (i.e. anhedonia), reduced social functioning, and impaired quality of life. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Major Depressive Disorder
- What is being tested?
- Rhythmic Sensory Stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- Apr 2016to Aug 2017
- 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 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Outpatients 18 to 60 years of age.
- Meet DSM-IV-TR criteria for major depressive episode (MDE) in major depressive disorder (MDD) without psychotic features, as determined by clinician assessment.
- Episode duration > 3 months.
- MADRS score ≥ 15 (mild to severe symptoms intensity).
- Fluency in English, sufficient to complete the interviews and self-report questionnaires.
- Satisfactory hearing bilaterally based on self-report.
Who cannot join
- Any Axis I diagnosis (other than MDD), and MDD with psychotic features,that is considered the primary diagnosis.
- Fibromyalgia diagnosis (FIQR score ≥ 39).
- Bipolar-I or Bipolar-II diagnosis (HCL score ≥ 14).
- Presence of a significant Axis II diagnosis (borderline, antisocial), judged as being primary based on clinician assessment.
- High suicidal risk, defined by clinician judgment.
- Substance dependence/abuse in the past 6 months.
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- Presence of significant neurological disorders, head trauma, or other unstable medical conditions.
- Acute and active inflammatory conditions, rheumatoid arthritis, osteoarthritis, autoimmune disease.
- History of epilepsy, seizures.
- Hemorrhaging or active bleeding.
- Hearing impairment.
- Thrombosis or heart diseases, including hypotension, arrhythmia, pacemaker, angina pectoris.
- Pregnant or breastfeeding.
- Recovering from recent accident with prolapsed vertebral disc, back or neck injury.
- Started psychological treatment within the past 3 months with the intent of continuing treatment.
- Patients who have changed medication or adjusted medication dosage within 4 weeks.
About this study
Official title: Examining the Effects of Music and Rhythmic Sensory Stimulation on Major Depressive Disorder
Major depressive disorder (MDD) is a highly prevalent and disabling disorder associated with persistent low mood, loss of the capacity to experience pleasure (i.e. anhedonia), reduced social functioning, and impaired quality of life. MDD is estimated to affect approximately 2% of Canadian women and 1% of Canadian men at any point in time. The World Health Organization affirms that depression is the leading cause of disability worldwide, with increasing global economic impact.
Standard treatments for depression include basic psychosocial support combined with antidepressant medication or psychotherapy. It has been observed, however, that only 50% of individuals respond to psychological treatment, and only 30-40% of patients achieve full remission after initial treatment with antidepressants. Music- and sound-related therapies have the potential to serve as adjuncts to, or facilitators of, medication.
Read more
In this study we will examine the effectiveness of a new therapeutic tool, known as Rhythmic Sensory Stimulation, as an adjunctive treatment for Major Depressive Disorder. Rhythmic Sensory Stimulation is a non-invasive brain stimulation technique that uses periodic pulses of light, sound, or tactile stimulus, to induce changes in the patterns of brain activity. Participants in this study will undertake 30 minutes of daily music intervention self-administered at home, for 5 days per week, for a total of 5 weeks. We will assess depression symptoms, sleep quality, quality of life, and brain activity pre- and post-treatment.
The results of the present study will help to better understand the effectiveness of Rhythmic Sensory Stimulation to the treatment of mood disorders, and contribute to the development of future studies to investigate the neural driving effects of therapies based on Rhythmic Sensory Stimulation.
Read the detailed description
Major depressive disorder (MDD) is a highly prevalent and disabling disorder associated with persistent low mood, loss of the capacity to experience pleasure (i.e. anhedonia), reduced social functioning, and impaired quality of life. MDD is estimated to affect approximately 2% of Canadian women and 1% of Canadian men at any point in time. The World Health Organization affirms that depression is the leading cause of disability worldwide, with increasing global economic impact.
Standard treatments for depression include basic psychosocial support combined with antidepressant medication or psychotherapy. It has been observed, however, that only 50% of individuals respond to psychological treatment, and only 30-40% of patients achieve full remission after initial treatment with antidepressants. Music- and sound-related therapies have the potential to serve as adjuncts to, or facilitators of, medication. Several recent systematic reviews have concluded that music is an effective therapeutic tool with significant results on improving global state, symptoms, and overall functioning, and is also well-accepted by patients.
The goal of this project is to evaluate the effectiveness of music and rhythmic sensory stimulation with low-frequency sounds as an adjunctive therapy for depression. Through a systematic collection of clinical, behavioural and electrophysiological measures, the project also aims to determine the possible mechanisms that underlie the effects of music- and sound-based therapies on symptoms of MDD. In addition to measures of depression severity and symptoms, we are also interested in secondary behavioral measures addressing possible confounding variables, such as anhedonia, quality of life, and individual differences in how people experience reward and pleasure associated with music. These assessments will allow an initial investigation of the neural correlates of the therapeutic effects of music in the treatment of depression, which is greatly warranted to better understand the efficacy of music- and sound-based treatments.
- Conditions
- Major Depressive Disorder
- Being tested
- Rhythmic Sensory Stimulation
- Keywords
- Unipolar, Depression, Depressive Disorder, Behavioural Symptoms, Mood Disorder, Adjunctive Therapy, Music Therapy, Brain Stimulation
- Medical subject headings
- Depressive Disorder, Major, Depression, Depressive Disorder, Behavioral Symptoms, Mood Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rhythmic Sensory StimulationDevice
The stimulation consists of 30 minutes of daily stimulation with specially composed relaxing music tracks embedded with gamma frequency sounds of 30-70 Hz range.
In this study, the stimuli will be delivered with a portable sound device called Sound Oasis Vibroacoustic Therapy System (VTS-1000) unit, which is a low-voltage consumer product that has two built in mid to high frequency speakers and one built in low frequency (subwoofer-type) speaker. The low frequency sounds played by the subwoofer speaker is experienced as vibrotactile vibration. Although the Intervention of Interest in this study is the Rhythmic Sensory Stimulation with low-frequency sounds, the efficacy of the Sound Oasis VTS-1000 device to deliver the intervention will also be subject to observation.
| Study group | Role | What they receive |
|---|---|---|
| Rhythmic Sensory Stimulation | Experimental | Participants in this group will undertake 30 minutes of daily Rhythmic Sensory Stimulation, for 5 day per week, for a total of 5 weeks. The stimulation consists of specially composed relaxing music tracks embedded with gamma frequency sounds of 30-70 Hz range. The intervention is conducted at the participant's home using a portable device called Sound Oasis Vibroacoustic Therapy System (VTS) 1000 unit. This device is a low-voltage consumer product device that has built in low frequency (subwoofer-type) speakers. The low frequency sounds played by the subwoofer speaker is experienced as vibrotactile vibration that is synchronized with the relaxing musical track. Receives: Device: Rhythmic Sensory Stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in MADRS (Montgomery-Asberg Depression Rating Scale) scores from baseline
Clinical response (≥ 50% reduction in MADRS scores from baseline)
Measured: Assessed at Week 0 (pre-intervention) and Week 6 (post-intervention)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Feb 2016 (estimated)
- Study startApr 2016
- Primary completionAug 2017
- Study completionAug 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Major Depressive DisorderStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Health Network, Toronto
- Sponsor type
- University, hospital or other
- Collaborators
- University of Toronto
- Responsible party
- Sponsor
- Investigators
- Sidney H Kennedy, MD, Principal investigator, University Health Network, TorontoLee Bartel, PhD, Principal investigator, University of Toronto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02685982
- Sponsor's protocol ID
- 15-9799
- Status last verified
- Oct 2016
- First submitted
- 11 Feb 2016
- Last updated
- 13 Dec 2017
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Yes: Data will be stored and shared through Ontario Brain Institute platform (BRAIN-Code).
Study at a glance
From the registry record, last updated by the sponsor on 13 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Examining the Effects of Music and Rhythmic Sensory Stimulation on Major Depressive Disorder
- ClinicalTrials.gov ID
- NCT02685982
- Acronym / sponsor ID
- 15-9799
- Conditions
- Major Depressive Disorder
- Keywords
- Unipolar, Depression, Depressive Disorder, Behavioural Symptoms, Mood Disorder, Adjunctive Therapy, Music Therapy, Brain Stimulation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University Health Network, TorontoUniversity, hospital or other
- Collaborators
- University of Toronto
- Study start
- Apr 2016 (actual)
- Primary completion
- Aug 2017 (actual)
- Study completion
- Aug 2017 (actual)
- First posted
- 19 Feb 2016 (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.
Major depressive disorder (MDD) is a highly prevalent and disabling disorder associated with persistent low mood, loss of the capacity to experience pleasure (i.e. anhedonia), reduced social functioning, and impaired quality of life. MDD is estimated to affect approximately 2% of Canadian women and 1% of Canadian men at any point in time. The World Health Organization affirms that depression is the leading cause of disability worldwide, with increasing global economic impact.
Standard treatments for depression include basic psychosocial support combined with antidepressant medication or psychotherapy. It has been observed, however, that only 50% of individuals respond to psychological treatment, and only 30-40% of patients achieve full remission after initial treatment with antidepressants. Music- and sound-related therapies have the potential to serve as adjuncts to, or facilitators of, medication.
In this study we will examine the effectiveness of a new therapeutic tool, known as Rhythmic Sensory Stimulation, as an adjunctive treatment for Major Depressive Disorder. Rhythmic Sensory Stimulation is a non-invasive brain stimulation technique that uses periodic pulses of light, sound, or tactile stimulus, to induce changes in the patterns of brain activity. Participants in this study will undertake 30 minutes of daily music intervention self-administered at home, for 5 days per week, for a total of 5 weeks. We will assess depression symptoms, sleep quality, quality of life, and brain activity pre- and post-treatment.
The results of the present study will help to better understand the effectiveness of Rhythmic Sensory Stimulation to the treatment of mood disorders, and contribute to the development of future studies to investigate the neural driving effects of therapies based on Rhythmic Sensory Stimulation.
Detailed description
Major depressive disorder (MDD) is a highly prevalent and disabling disorder associated with persistent low mood, loss of the capacity to experience pleasure (i.e. anhedonia), reduced social functioning, and impaired quality of life. MDD is estimated to affect approximately 2% of Canadian women and 1% of Canadian men at any point in time. The World Health Organization affirms that depression is the leading cause of disability worldwide, with increasing global economic impact.
Standard treatments for depression include basic psychosocial support combined with antidepressant medication or psychotherapy. It has been observed, however, that only 50% of individuals respond to psychological treatment, and only 30-40% of patients achieve full remission after initial treatment with antidepressants. Music- and sound-related therapies have the potential to serve as adjuncts to, or facilitators of, medication. Several recent systematic reviews have concluded that music is an effective therapeutic tool with significant results on improving global state, symptoms, and overall functioning, and is also well-accepted by patients.
The goal of this project is to evaluate the effectiveness of music and rhythmic sensory stimulation with low-frequency sounds as an adjunctive therapy for depression. Through a systematic collection of clinical, behavioural and electrophysiological measures, the project also aims to determine the possible mechanisms that underlie the effects of music- and sound-based therapies on symptoms of MDD. In addition to measures of depression severity and symptoms, we are also interested in secondary behavioral measures addressing possible confounding variables, such as anhedonia, quality of life, and individual differences in how people experience reward and pleasure associated with music. These assessments will allow an initial investigation of the neural correlates of the therapeutic effects of music in the treatment of depression, which is greatly warranted to better understand the efficacy of music- and sound-based treatments.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Rhythmic Sensory Stimulation | Experimental | Device: Rhythmic Sensory StimulationParticipants in this group will undertake 30 minutes of daily Rhythmic Sensory Stimulation, for 5 day per week, for a total of 5 weeks. The stimulation consists of specially composed relaxing music tracks embedded with gamma frequency sounds of 30-70 Hz range. The intervention is conducted at the participant's home using a portable device called Sound Oasis Vibroacoustic Therapy System (VTS) 1000 unit. This device is a low-voltage consumer product device that has built in low frequency (subwoofer-type) speakers. The low frequency sounds played by the subwoofer speaker is experienced as vibrotactile vibration that is synchronized with the relaxing musical track. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Outpatients 18 to 60 years of age.
- Meet DSM-IV-TR criteria for major depressive episode (MDE) in major depressive disorder (MDD) without psychotic features, as determined by clinician assessment.
- Episode duration > 3 months.
- MADRS score ≥ 15 (mild to severe symptoms intensity).
- Fluency in English, sufficient to complete the interviews and self-report questionnaires.
Key exclusion criteria (16 listed)
- Any Axis I diagnosis (other than MDD), and MDD with psychotic features,that is considered the primary diagnosis.
- Fibromyalgia diagnosis (FIQR score ≥ 39).
- Bipolar-I or Bipolar-II diagnosis (HCL score ≥ 14).
- Presence of a significant Axis II diagnosis (borderline, antisocial), judged as being primary based on clinician assessment.
- High suicidal risk, defined by clinician judgment.
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 |
|---|---|---|
| Rhythmic Sensory StimulationThe stimulation consists of 30 minutes of daily stimulation with specially composed relaxing music tracks embedded with gamma frequency sounds of 30-70 Hz range. In this study, the stimuli will be delivered with a portable sound device called Sound Oasis Vibroacoustic Therapy System (VTS-1000) unit, which is a low-voltage consumer product that has two built in mid to high frequency speakers and one built in low frequency (subwoofer-type) speaker. The low frequency sounds played by the subwoofer speaker is experienced as vibrotactile vibration. Although the Intervention of Interest in this study is the Rhythmic Sensory Stimulation with low-frequency sounds, the efficacy of the Sound Oasis VTS-1000 device to deliver the intervention will also be subject to observation. | Device | Rhythmic Sensory Stimulation |
Primary outcome
Change in MADRS (Montgomery-Asberg Depression Rating Scale) scores from baseline
Time frame: Assessed at Week 0 (pre-intervention) and Week 6 (post-intervention)
Clinical response (≥ 50% reduction in MADRS scores from baseline)
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 13 Dec 2017.
- CAN-BIND websiteLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. Data will be stored and shared through Ontario Brain Institute platform (BRAIN-Code).
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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.
Sidney H Kennedy, MD principal investigator
University Health Network, Toronto
Lee Bartel, PhD principal investigator
University of Toronto
Questions about this trial
What is this clinical trial studying?
A study testing Rhythmic Sensory Stimulation in people with Major Depressive Disorder, run by University Health Network, Toronto.
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 6 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 13 Dec 2017. Status can change between updates, so confirm with the study contact before making plans.
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 MADRS (Montgomery-Asberg Depression Rating Scale) scores from baseline (time frame: Assessed at Week 0 (pre-intervention) and Week 6 (post-intervention)). It is what the study was designed to measure, not a finding.
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 13 Dec 2017.