Depression Clinical Trial
— TIDEOfficial title:
Treatment Interrupts Depression Early
The TIDE project aims to establish personal indicators for initial treatment choice for youth with first episode depression. Specifically, 100 adolescents and young adults (age 12 to 25) with untreated major depressive disorder of recent onset will be randomly allocated in 1:1 ratio to one of two evidence-based regimens for youth depression: (A) Individual cognitive-behavioural therapy; and (B) Optimized pharmacological treatment with an antidepressant. All participants will be offered active treatment for up to 1 year and follow-up for 2 years to establish short- and long-term outcomes, including change in depressive symptoms, maintenance of remission, core role functioning, achievement of educational, occupational and social milestones, and quality of life. Baseline characteristics including duration of untreated depression, pre-existing anxiety, attention-deficit/hyperactivity disorder, substance use, symptoms of reduced interest and activity, sleep, rhythm and melody of speech, brain function, history of childhood adversity, coping style, repetitive thinking, and family history of depression and bipolar disorder will be tested as potential moderators of outcome. Characteristics that differentially predict outcomes in those allocated to initial cognitive-behavioural therapy and those allocated to initial treatment with antidepressants will be combined into a personalized allocation algorithm.
Status | Recruiting |
Enrollment | 100 |
Est. completion date | December 31, 2026 |
Est. primary completion date | December 31, 2026 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 12 Years to 25 Years |
Eligibility | Inclusion Criteria: - Age 12-25 years - Diagnosis of major depressive disorder, onset of the major depressive disorder within the last 12 months. Depression considered the most significant problem in need of treatment. - An additional inclusion criterion for entering Stage 1 (active intervention) is a minimum moderate depression severity (CDRS-R=40; MADRS=20) that justifies the need for treatment. Individuals who fulfill general inclusion criteria but are below the depression severity threshold for active intervention will still be eligible to participate in follow-up assessments. - Verbal ability sufficient to participate in psychological treatment. Exclusion Criteria: - Personal history of a manic or hypomanic episode, diagnosis of a psychotic disorder, pervasive developmental disorder or autism spectrum disorder, intellectual disability, mental disorders secondary to neurological or other medical condition, active substance use disorder. - Previous trial of any treatment for major depressive disorder lasting 4 weeks or longer, current use of antipsychotic, antidepressant or mood-stabilizer medication. - Recent (past 6 weeks) change in any psychotropic medication (including stimulants, hypnotics, anxiolytics) or receipt of 4 of more sessions of cognitive-behavioural therapy. - Pregnancy or breastfeeding. If participants become pregnant or learn of pregnancies during the study, we will consult with Dr. Tanya Tulipan and jointly make the best decision for the participant with the option to either continue or end study treatment. - No one will be excluded based on sex, gender, race, ethnicity, or living arrangements. |
Country | Name | City | State |
---|---|---|---|
Canada | Nova Scotia Health | Halifax | Nova Scotia |
Lead Sponsor | Collaborator |
---|---|
Rudolf Uher |
Canada,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Functioning score | Functioning will be defined as a continuous score on CCIS-R Columbia Child Impairment Scale - Revised (CCIS-R - 12-17 years) or Social and Occupational Functioning Assessment Scale (SOFAS - 18 years+), standardized for each age group. Higher score indicates better functioning. | 1-104 weeks | |
Other | Developmental milestones achievement | At stage 3, long-term functional outcomes will be the achievement of age-appropriate milestones defined as a number and timing of milestones achieved relative to the person's age and school grade.A single score will be derived summarizing the achievement of milestones relative to a normative sample of young people of similar age. Higher score indicates better functioning. | 1-104 weeks | |
Primary | Severity of depressive symptoms | The primary outcome measure at Stage 1 will be the severity of depressive symptoms, indexed with the Montgomery-Åsberg Depression Rating Scale (MADRS) total score. The MADRS is scored on a scale from 0-60, the higher the score the higher the severity of symptoms. | 1-16 weeks | |
Primary | Severity of depressive symptoms | The primary outcome measure at Stage 2 will be the severity of depressive symptoms, indexed with the Montgomery-Åsberg Depression Rating Scale (MADRS) total score. The MADRS is scored on a scale from 0-60, the higher the score the higher the severity of symptoms. | 16-32 weeks | |
Primary | Proportion of time spent depression free | At Stage 3 follow-up, the primary outcome will be the proportion of time spent depression free, defined as a score of 1 or 0 on Longitudinal Interval Follow-up Evaluation (LIFE). | 16-104 weeks | |
Secondary | Self-reported measure of depression. | Secondary outcomes will include a self-reported measure of depression (Quick Inventory of Depressive Symptomatology: QIDS). The QIDS is scored on a scale from 0-27, the higher the score the higher the severity of depressive symptoms. | 1-104 weeks | |
Secondary | Self-reported measure of generalized anxiety. | Secondary outcomes will include a self-reported measures of anxiety (General Anxiety Disorder-7: GAD-7. The GAD-7 is scored on a scale from 0-21, the higher the score the higher the severity of symptoms. | 1-104 weeks | |
Secondary | Self-reported measure of social anxiety. | Secondary outcomes will include self-reported measures of social anxiety (Social Phobia Inventory: SPIN). The SPIN is scored on a scale from 0-68, the higher the score the greater the distress from symptoms. | 1-104 weeks | |
Secondary | Self-reported measures of general psychopathology. | Secondary outcomes will include self-reported measures of general psychopathology (Youth Experiences Tracker Instrument: YETI). The YETI is scored on a scale from 0-78, the higher the score the higher the severity of symptoms. | 1-104 weeks | |
Secondary | Self-reported measure of quality of life. | Secondary outcomes will include self-reported measure of quality of life (Quality of Life Enjoyment & Satisfaction Questionnaire: QLES-Q). The QLES-Q has a maximum score of 70, higher scores indicating greater life satisfaction and enjoyment. | 1-104 weeks | |
Secondary | Objective measures of psychopathology. | Objective measures of psychopathology (speech). A score from the acoustics and content of speech indicative of depressive symptomatology. Standard scale. Higher score indicates more severe symptoms. | 1-104 weeks | |
Secondary | Objective measure of physical activity. | Objective measure of physical activity with an actigraph. Single continuous score.Higher score indicates more activity, which is a positive outcome. | 1-104 weeks | |
Secondary | Objective measures of sleep. | Objective measure of total durarion of sleep with an actigraph. | 1-104 weeks | |
Secondary | Objective measures of educational progress. | Objective measures of educational progress using transcripts, grade completion, and graduation. A single score will be derived summarizing the educational progress relative to a normative sample of young people of similar age. Higher score indicates better educational achievement. | 1-104 weeks |
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