Major Depressive Disorder Clinical Trial
Official title:
Examining the Effects of Music and Rhythmic Sensory Stimulation on Major Depressive Disorder
Verified date | October 2016 |
Source | University Health Network, Toronto |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 20 |
Est. completion date | August 2017 |
Est. primary completion date | August 2017 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 70 Years |
Eligibility |
Inclusion Criteria: - 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. Exclusion Criteria: - 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. - 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. |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
University Health Network, Toronto | University of Toronto |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in MADRS (Montgomery-Asberg Depression Rating Scale) scores from baseline | Clinical response (= 50% reduction in MADRS scores from baseline) | Assessed at Week 0 (pre-intervention) and Week 6 (post-intervention) |
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