Comparing Cognitive-Behavioural Therapy with Antidepressant medication for depression
Official title: Treatment Interrupts Depression Early
Interventions
Cognitive-Behavioural Therapy
20 sessions of individual CBT are offered over 16 weeks, conducted 1-on-1, with a trained and supervised therapist. Participants will learn about the cognitive, behavioural, emotional, and environmental factors which contribute to maintaining their depression. They will apply skills to interrupt unhelpful cognitive and behavioural patterns and engage in guided exploration to improve self-understanding. CBT is a structured and collaborative treatment. Weekly "homework" will be used to maximize opportunities for practice and consolidation of new skills. The individual sessions can be combined with optional family/parent/partner sessions, depending on the situation and preferences of the participant. All sessions will be video-recorded to allow high-quality supervision, fidelity- and quality-assurance. This corresponds to evidence available for CBT for adolescents and young adults that is established as the best practice through rigorous trials.
Antidepressant medication
The choice of antidepressants follows best-established evidence for treating depression in adolescents and young adults. We will offer treatment with fluoxetine, starting at 10mg a day, increasing to 20mg a day after 1 week if tolerated; a protocol established as safe and effective in adolescents and adults in multiple trials. Additional increases to 40 or 60mg will be possible based on positive effects and side-effects and clinical judgement, as recommended in this age group. In cases of intolerance or adverse reaction to fluoxetine, we will switch to sertraline (25-200mg) or escitalopram (5-20mg), two antidepressants licensed by the FDA for major depressive disorder in adolescents. Treatment will be optimized over 16 weeks, a time-frame comparable to the CBT arm. Pharmacotherapy will be managed and prescribed by qualified psychiatrists when starting treatment and reviewed after 1 week, 2 weeks and then in 2-weekly intervals for the remainder of the 16 weeks acute treatment period.
Canadian Sites (2)
Nova Scotia Health
Halifax, Nova Scotia, Canada
Centre intégré universitaire de santé et de services sociaux de l'Ouest-de-l'Île-de-Montréal / Centre de Recherche Douglas (Montreal West Island IUHSSC / Douglas Research Center)
Montreal, Quebec, Canada
Eligibility Criteria
See who this study is looking for9 criteria
The trial’s own eligibility text, word for word from the registry. Only the trial site can say who takes part.
Inclusion
- +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 criterionInclusion criteriaThe things you must have or be for a study to consider you.Read more → 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-upFollow-upContinued check-ins after the treatment part is finished.Read more → assessments.
- +Verbal ability sufficient to participate in psychological treatment.
Exclusion
- −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.
- −No one will be excluded based on sex, gender, race, ethnicity, or living arrangements.
- −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.
In plain language
Assembled directly from this trial’s registry record. Every sentence traces to a field below — nothing here is generated or interpreted.
What this study is
This study is testing a treatment for a condition.
Phase 2Phase 2A middle-stage study looking at what a treatment does and watching for side effects.Read more → — a middle-stage study in a few hundred people at most, looking at what the treatment does and watching for side effectsSide effectAn unwanted effect thought to be caused by the treatment itself.Read more →.
What is being given or done in this study: Cognitive-Behavioural Therapy, Antidepressant medication.
From the trial registry
Built from these fields:
- designModule.designInfo.primaryPurpose
- designModule.phases
- armsInterventionsModule.interventions[].name
How the study is run
Which group you would be placed in is decided by chance, like a coin flip — not by you and not by your doctor.
This study is open-labelOpen-labelEveryone knows which treatment is being given — nothing is hidden.Read more →: everyone knows which treatment is being given, including you and the study team.
From the trial registry
Built from these fields:
- designModule.designInfo.allocation
- designModule.designInfo.maskingInfo.masking
Is there a placebo?
This study does not list a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → group.
There are 2 groups in this study.
From the trial registry
Built from this field:
- armsInterventionsModule.armGroups[].type
Who the study is looking for
The study lists an age range of 12 years to 25 years.
The study is open to people of any sex.
The study does not accept healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more →.
These are the criteria the study lists. Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part.
From the trial registry
Built from these fields:
- eligibilityModule.minimumAge
- eligibilityModule.maximumAge
- eligibilityModule.sex
- eligibilityModule.healthyVolunteers
How big and how long
The study aims to enrol about 100 people.
The study is currently expected to finish around December 2028.
The main measurement is taken over: 1-16 weeks.
From the trial registry
Built from these fields:
- designModule.enrollmentInfo.count
- statusModule.completionDateStruct.date
- outcomesModule.primaryOutcomes[].timeFrame
What the study measures
Severity of depressive symptoms — measured over 1-16 weeks.
Severity of depressive symptoms — measured over 16-32 weeks.
Proportion of time spent depression free — measured over 16-104 weeks.
From the trial registry
Built from these fields:
- outcomesModule.primaryOutcomes[].measure
- outcomesModule.primaryOutcomes[].timeFrame
Source: NCT05002309 on ClinicalTrials.gov. The full registry text is further down this page — this summary never replaces it.
Not medical advice. What do these terms mean?
What is being tested — in plain terms
About Cognitive-Behavioural TherapyBehavioural
20 sessions of individual CBT are offered over 16 weeks, conducted 1-on-1, with a trained and supervised therapist. Participants will learn about the cognitive, behavioural, emotional, and environmental factors which contribute to maintaining their depression. They will apply skills to interrupt unhelpful cognitive and behavioural patterns and engage in guided exploration to improve self-understanding. CBT is a structured and collaborative treatment. Weekly "homework" will be used to maximize opportunities for practice and consolidation of new skills. The individual sessions can be combined with optional family/parent/partner sessions, depending on the situation and preferences of the participant. All sessions will be video-recorded to allow high-quality supervision, fidelity- and quality-assurance. This corresponds to evidence available for CBT for adolescents and young adults that is established as the best practice through rigorous trials.
From the trial registry — its own words, unedited.
What a behavioural is here: A programme, therapy, education, or lifestyle approach being studied.
Read the full explanation → · in clinical review
About Antidepressant medicationDrug
The choice of antidepressants follows best-established evidence for treating depression in adolescents and young adults. We will offer treatment with fluoxetine, starting at 10mg a day, increasing to 20mg a day after 1 week if tolerated; a protocol established as safe and effective in adolescents and adults in multiple trials. Additional increases to 40 or 60mg will be possible based on positive effects and side-effects and clinical judgement, as recommended in this age group. In cases of intolerance or adverse reaction to fluoxetine, we will switch to sertraline (25-200mg) or escitalopram (5-20mg), two antidepressants licensed by the FDA for major depressive disorder in adolescents. Treatment will be optimized over 16 weeks, a time-frame comparable to the CBT arm. Pharmacotherapy will be managed and prescribed by qualified psychiatrists when starting treatment and reviewed after 1 week, 2 weeks and then in 2-weekly intervals for the remainder of the 16 weeks acute treatment period.
From the trial registry — its own words, unedited.
What a drug is here: A medicine — a chemical or small-molecule treatment — given as the thing being studied.
Read the full explanation → · in clinical review
Common questions
Answered from this trial’s registry record. Where the record doesn’t say, these answers say so rather than filling the gap.
Am I eligible for this trial?
Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part. Concord cannot make that determination, and neither can any tool that has not examined you.
What the study lists: an age range of 12 years to 25 years.
The full inclusionInclusion criteriaThe things you must have or be for a study to consider you.Read more → and exclusion criteriaExclusion criteriaThe things that would prevent someone from taking part.Read more → are published on this page, exactly as the study team wrote them.
The useful next step is to bring this trial to your doctor. Answering a few questions first gives them something concrete to review.
From the trial registry
- eligibilityModule.minimumAge
- eligibilityModule.maximumAge
- eligibilityModule.eligibilityCriteria
Is there a placebo?
This study does not list a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → group.
From the trial registry
- armsInterventionsModule.armGroups[].type
Would I know which treatment I am getting?
This study is open-labelOpen-labelEveryone knows which treatment is being given — nothing is hidden.Read more →: everyone knows which treatment is being given, including you and the study team.
Which group you would be placed in is decided by chance, like a coin flip — not by you and not by your doctor.
From the trial registry
- designModule.designInfo.maskingInfo.masking
- designModule.designInfo.allocation
Who can join?
The study lists an age range of 12 years to 25 years.
It is open to people of any sex.
It does not accept healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more →.
Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can confirm whether a particular person can take part.
From the trial registry
- eligibilityModule.minimumAge
- eligibilityModule.maximumAge
- eligibilityModule.sex
- eligibilityModule.healthyVolunteers
How long would this take?
The study's main measurement is taken over: 1-16 weeks.
The study as a whole is currently expected to finish around 2028-12-31.
How long any one person takes part can differ from the study length. The study team can tell you what the schedule looks like in practice.
From the trial registry
- outcomesModule.primaryOutcomes[].timeFrame
- statusModule.completionDateStruct.date
How many people are taking part?
The study aims to enrol about 100 people.
From the trial registry
- designModule.enrollmentInfo.count
Where is this happening?
This study lists 2 locations, including: Halifax, Nova Scotia, Canada; Montreal, Quebec, Canada.
Sites can open and close during a study, so confirm with the team before travelling.
From the trial registry
- trial_locations
About This Trial
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.
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See if this trial could fit youThis page is for informational purposes only and does not constitute medical advice. Clinical trial eligibility can only be determined by the trial site after proper screening. Trial information is sourced from ClinicalTrials.gov and may not reflect the most current status. Always consult your healthcare provider before making decisions about clinical trial participation.