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Antidepressant

Cognitive-Behavioral Therapy vs Antidepressants for Depression (TIDE Trial)

Phase 2
Recruiting
Led By Rudolf Uher, MD, PhD
Research Sponsored by Rudolf Uher
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Age 12-25 years
Minimum moderate depression severity (CDRS-R≥40; MADRS≥20) for active intervention
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 16-104 weeks
Awards & highlights

TIDE Trial Summary

This trialaims to find personal indicators to help choose the best treatment for young people with first episode depression. 100 participants will be randomly given either CBT or antidepressant meds, followed up for 2 years to track symptoms, functioning, & quality of life.

Who is the study for?
This trial is for young people aged 12-25 with recent-onset major depressive disorder, where depression is the main issue. They must have moderate severity of depression and be able to engage in therapy. Excluded are those who've had prior treatment for depression lasting 4+ weeks, current psychotropic medication use, certain psychiatric diagnoses, or substance abuse issues.Check my eligibility
What is being tested?
The TIDE project tests two treatments for youth depression: cognitive-behavioural therapy (CBT) and optimized antidepressant medication. Participants will be randomly assigned to one of these treatments and monitored up to two years to see how they affect symptoms, life functioning, and quality of life.See study design
What are the potential side effects?
Potential side effects from CBT may include emotional discomfort due to confronting difficult feelings or thoughts. Antidepressants can cause nausea, weight gain, sleep disturbances, sexual dysfunction among others; specific side effects depend on the type of medication used.

TIDE Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am between 12 and 25 years old.
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I have moderate to severe depression.
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I was diagnosed with major depression in the last year and it's my main health issue.

TIDE Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~16-104 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 16-104 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Proportion of time spent depression free
Severity of depressive symptoms
Secondary outcome measures
Objective measure of physical activity.
Objective measures of educational progress.
Objective measures of psychopathology.
+6 more
Other outcome measures
Developmental milestones achievement
Functioning score

TIDE Trial Design

2Treatment groups
Experimental Treatment
Group I: PsychotherapyExperimental Treatment1 Intervention
Cognitive-behavioural therapy
Group II: PharmacotherapyExperimental Treatment1 Intervention
Antidepressant medication
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Cognitive-Behavioural Therapy
2016
N/A
~320
Antidepressant medication
2003
Completed Phase 1
~170

Find a Location

Who is running the clinical trial?

Rudolf UherLead Sponsor
1 Previous Clinical Trials
30,000 Total Patients Enrolled
1 Trials studying Depression
30,000 Patients Enrolled for Depression
Rudolf Uher, MD, PhDPrincipal InvestigatorNova Scotia Health Authority
4 Previous Clinical Trials
30,784 Total Patients Enrolled
3 Trials studying Depression
30,664 Patients Enrolled for Depression

Media Library

Antidepressant medication (Antidepressant) Clinical Trial Eligibility Overview. Trial Name: NCT05002309 — Phase 2
Depression Research Study Groups: Pharmacotherapy, Psychotherapy
Depression Clinical Trial 2023: Antidepressant medication Highlights & Side Effects. Trial Name: NCT05002309 — Phase 2
Antidepressant medication (Antidepressant) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05002309 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Has the government given its endorsement to Pharmacotherapy?

"There is evidence of Pharmacotherapy's safety, so it received a rating of 2. However, due to the Phase 2 trial status, data supporting efficacy has yet to be collected."

Answered by AI

Is the eligibility criteria for this trial limited to those twenty or younger?

"The parameters of this medical study necessitate that participants be between 12 and 25 years old. There are 185 clinical trials for minors, while 956 exist for elderly patients."

Answered by AI

Does this research allow for participant involvement?

"To be admitted to this trial, potential participants must satisfy two criteria: suffering from depression and being between the ages of 12 and 25. A total of 100 individuals will be accepted."

Answered by AI

What main goals is this trial attempting to achieve?

"This trial will measure the seriousness of depression symptoms over a period ranging from 16-104 weeks. Secondary outcomes include objective estimations of mental illness, educational progress and physical activity with each having their own scoring system to indicate severity/achievement respectively."

Answered by AI

How many participants are taking part in this clinical trial?

"Affirmative. According to clinicaltrials.gov, the medical study that was first posted on December 2nd 2021 is actively seeking volunteers. This trial requires 100 patients at a single site in order to be completed successfully."

Answered by AI

Is there still room for participants in this experiment?

"According to its listing on clinicaltrials.gov, this trial is presently accepting applicants after being initially posted on December 2nd 2021 and most recently updated on February 6th 2023."

Answered by AI
~53 spots leftby Dec 2026