Recruiting
Phase 2

CBT & Antidepressants

Sponsor:

Nova Scotia Health Authority

Code:

NCT05002309

Conditions

Depression

Eligibility Criteria

Sex: All

Age: 12 - 25

Healthy Volunteers: Not accepted

Interventions

Cognitive-Behavioural Therapy

Antidepressant medication

Study Details

Brief summary:

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.

Conditions

Depression

Study ID

NCT05002309

Start date

Dec 2, 2021

Status verified date

May, 2025

Completion date

Dec 31, 2028

Anticipated

Primary completion date

Jun 30, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 12 - 25

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

100 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Psychotherapy

Cognitive-behavioural therapy

experimental: Pharmacotherapy

Antidepressant medication

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.

Primary outcome measure

  • Severity of depressive symptoms [ Time Frame: 1-16 weeks ]
  • Severity of depressive symptoms [ Time Frame: 16-32 weeks ]
  • Proportion of time spent depression free [ Time Frame: 16-104 weeks ]

Central Contacts and Locations

Central contacts

Rudolf Uher, MD, PhD

902-473-7209uher@dal.ca

Jill Cumby, RN, MN

902-473-1781jill.cumby@nshealth.ca

Locations

Nova Scotia Health

Recruiting

Halifax, Nova Scotia, Canada, B#H 2E2

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)

Recruiting

Montreal, Quebec, Canada, H4H 1R3

Contacts

Philippe Guévremont, MDCM

514-761-6131inspirelab.tide@gmail.com

Principal Investigator:

Anthony Gifuni, MD

More Information

Sponsor

Nova Scotia Health Authority

Last update posted

May 14, 2025

Last verified

May, 2025

Keywords

  • Severe mental illness

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Nova Scotia Health Authority on 2025-05-14.