Rapid Antidepressant Improvement Secondary to Excitatory Brain Responses
NCT04276259
Behavior, Behavioral Symptoms
Pittsburgh, Pennsylvania, United States
View Trial DetailsNCT Number: NCT02998762
The LTFU study will conduct a naturalistic follow up of the well characterized CAN-BIND study population of patients every six months and continuing over a five-year period. This will provide information on the longitudinal progress in mood, functioning, and quality of life of the CAN-BIND sample with a view towards long-term outcome and treatment.
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Notify Me18 year–60 year
All sexes
Observational
University of Calgary, Calgary, Alberta, Canada
This is a long-term follow up study of the 'Canadian Biomarker Integration Network in Depression' (CAN-BIND) study. The CAN-BIND study examines biological markers of antidepressant treatment response. The examined biomarkers included clinical, imaging, and genetic components. The Long Term Follow up (LTFU) study will continue to follow the patients in this study each six months over a five year period. By doing so, a comprehensive clinical outcome data on a well characterized cohort of depressed patients will be obtained.
The research team will conduct a naturalistic study of CAN-BIND participants and will monitor the longitudinal progress in mood, functioning, and quality of life, with a view towards advising future treatment options. Each patient completing CAN-BIND will be asked to participate in the LTFU study.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Time frame: Every six months up to Year 5
Clinical response (equal to or greater than 50% reduction in MADRS scores from CAN-BIND baseline); Relapse is determined if the MADRS score is greater than or equal to 22 or there is suicidal ideation with intent, or suicidal behaviour.
Time frame: Every six months up to Year 5
The LIFE is a clinician-rated interview that provides a structure for collecting and coding data on the longitudinal course of psychopathology. It allows for precise dating of onset and offset of symptoms (including sub-syndromal symptoms) and ranks severity on a week by week basis.
Time frame: Every six months up to Year 5
The LEDS is a semi-structured interview that collects detailed contextual information regarding acute stressful life events and chronic difficulties in several domains.
Time frame: Every six months up to Year 5
The QIDS-SR is a 16 item scale used to assess the severity of depressive illness derived from the 30-item Inventory of Depressive Symptomatology (IDS). The scale includes questions on mood, sleep and level of interest, and takes 5-10 minutes to complete.
Time frame: Every six months up to Year 5
This 16-item questionnaire contains questions about your general life satisfaction on aspects such as physical health, leisure time and overall sense of well-being. Each item is scored on a 5-point scale (very poor to very good); higher scores indicate greater satisfaction and enjoyment. It takes 5 minutes to complete.
Time frame: Every six months up to Year 5
The SDS-VAS is a self-rated questionnaire that assesses functional disability and impairment due to psychiatric symptoms. The SDS-VAS consists of three functional impairment items and two items related to productivity losses due to the symptoms and impairment. Impairment is evaluated with the 10-point self-rated social life and family life/home responsibilities subscales of the Sheehan Disability Scale (0, none; 1-3, mild; 4-6, moderate; 7-9, marked; 10, extreme). Significant impairment for each subscale was defined by a rating of 7 or higher.
Time frame: Every six months up to Year 5
The DARS is a new measure of anhedonia developed to address the limitations of the existing scales. It extends the concept of anhedonia to assess desire, motivation, effort and consummatory pleasure across four domains: pastimes/hobbies, food/drink, social activities and sensory experiences. Individuals are asked to list their own examples within each domain and respond to standardized questions on a Likert scale according to how they are feeling "right now".
Time frame: Every six months up to Year 5
The WHOQOL-BREF is a 26-item self-rated questionnaire that assesses perceived quality of life across four domains. The domains of health assessed include physical health, psychological health, social relationships and environment. Domain scores and global scores can be generated. The questions are related to aspects of the patient's life in the last four weeks.
Time frame: Every six months up to Year 5
The BSI-53 is a 53-item self-rated questionnaire that assesses depression across nine symptom dimensions. The nine dimensions are somatization, obsession-compulsion, interpersonal sensitivity, depression, anxiety, hostility, phobic anxiety, paranoid ideation and psychoticism. The number and intensity of symptomatology is given by three indices, the Global Severity Index, Positive Symptom Distress Index and Positive Symptom Total (PST). Each item is ranked on a 5-point scale from 0 (not at all) to 4 (extremely), and rankings represent intensity of distress over the past week.
Time frame: Every six months up to Year 5
The GAD-7 is a 7-item self-rated questionnaire with good reliability and validity for assessing generalized anxiety disorder and its severity over the past two weeks. Items are ranked on a 4-point scale from 0 (not at all sure) to 3 (nearly every day), providing a total severity score from 0 to 21.
Time frame: Every six months up to Year 5
The PSQI is a self-rated questionnaire specifically designed to measure sleep quality. The questionnaire includes questions on sleep duration, sleep disturbance, sleep latency, day dysfunction due to sleepiness, sleep efficiency, overall sleep quality and need for medication to sleep. This questionnaire takes less than 5 minutes to complete.
Time frame: Every six months up to Year 5
The CBI consists of three scales measuring personal burnout, work-related burnout, and client-related burnout, for use in different domains. Each subscale on the CBI is scored from a range of 0 to 100. Respondents who gained an average score of 50 or higher on each of the scales are deemed to have a positive response to the screen and to warrant further investigation by a mental health professional.
Sidney Kennedy
Other
CAN-BIND (Canadian Biomarker Integration Network for Depression): Long-Term Follow Up Study
Acronym: CAN-BIND LTFU
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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