Cognitive-Behavioral Therapy vs Antidepressants for Depression
(TIDE Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores the best initial treatment for young people experiencing their first episode of depression. Participants will receive either cognitive-behavioral therapy (a type of talk therapy) or antidepressant medication to determine which approach is more effective. The study aims to identify personal indicators that guide the choice of treatment for each individual. It suits those aged 12 to 25 who have been dealing with major depression for less than a year and consider it their primary issue needing treatment. As a Phase 2 trial, the research focuses on measuring the treatment's effectiveness in an initial, smaller group of people.
Do I have to stop taking my current medications to join the trial?
Yes, you must stop taking any current antipsychotic, antidepressant, or mood-stabilizer medications. Additionally, you should not have changed any psychotropic medication in the past 6 weeks.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research shows that cognitive-behavioral therapy (CBT) is a safe way to treat depression. As a type of talk therapy, many people find it easy to handle. Unlike medications, CBT has no side effects. Studies have proven it to be an effective and evidence-based method for treating depression.
In contrast, antidepressant medications, like fluoxetine, have long been used to treat depression and are approved by the FDA. However, they carry some risks, especially for young people. Children, teenagers, and young adults taking these medications may experience increased suicidal thoughts. Monitoring for any unusual changes in mood or behavior while using these medications is important.
Overall, CBT is generally safe with no serious side effects, while antidepressants are effective but may require careful monitoring due to potential risks.12345Why are researchers excited about this trial's treatments?
Researchers are excited about these treatments for depression because they offer unique approaches compared to standard care options like SSRIs or SNRIs. Cognitive-Behavioral Therapy (CBT) is distinctive due to its focus on changing thought patterns and behaviors without medication, potentially reducing side effects and promoting long-term mental health skills. Antidepressant medications, while traditional, are being explored in new combinations or dosages to optimize effectiveness and minimize side effects. This dual approach allows for a tailored treatment plan, potentially offering quicker and more sustainable relief for patients.
What evidence suggests that this trial's treatments could be effective for depression?
This trial will compare the effectiveness of antidepressant medication and cognitive-behavioral therapy (CBT) for treating depression. Studies have shown that both antidepressants, such as fluoxetine, and CBT effectively treat depression. Antidepressants can reduce symptoms in many people, with some studies showing they work better than placebos. Research indicates that antidepressants significantly decrease depression symptoms for many individuals. Similarly, CBT has demonstrated strong results, with moderate to large improvements in symptoms. In some studies, CBT has been as effective as other treatments for depression. Both treatments have solid evidence supporting their effectiveness in managing depression symptoms.678910
Who Is on the Research Team?
Rudolf Uher, MD
Principal Investigator
Nova Scotia Health Authority
Are You a Good Fit for This Trial?
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.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Active Intervention
Participants receive either cognitive-behavioral therapy or optimized antidepressant treatment
Continuation Treatment and Cross-over Options
Continuation of initial treatment or cross-over to the other treatment based on remission status
Follow-up
Participants are monitored for stability of remission and functional outcomes
What Are the Treatments Tested in This Trial?
Interventions
- Antidepressant medication
- Cognitive-Behavioural Therapy
Trial Overview
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.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Cognitive-behavioural therapy
Antidepressant medication
Antidepressant medication is already approved in United States, European Union, Canada for the following indications:
- Major Depressive Disorder
- Obsessive Compulsive Disorder
- Bulimia Nervosa
- Panic Disorder
- Depressive Episodes Associated with Bipolar I Disorder
- Treatment Resistant Depression
- Major Depressive Disorder
- Obsessive Compulsive Disorder
- Bulimia Nervosa
- Panic Disorder
- Premenstrual Dysphoric Disorder
- Major Depressive Disorder
- Obsessive Compulsive Disorder
- Bulimia Nervosa
- Panic Disorder
Find a Clinic Near You
Who Is Running the Clinical Trial?
Nova Scotia Health Authority
Lead Sponsor
Rudolf Uher
Lead Sponsor
Citations
Efficacy and Safety of Olanzapine/Fluoxetine Combination ...
This study assessed prevention of relapse in patients with treatment-resistant depression (TRD) taking olanzapine/fluoxetine combination (OFC).
Efficacy of Olanzapine and Olanzapine-Fluoxetine ...
Results During all 8 study weeks, the olanzapine and olanzapine-fluoxetine groups showed statistically significant improvement in depressive symptoms vs the ...
a systematic review and network meta-analysis
In terms of efficacy, all antidepressants were more effective than placebo, with ORs ranging between 2·13 (95% credible interval [CrI] 1·89–2·41) ...
Relative effectiveness of antidepressant treatments in ...
Data analysis. The primary efficacy outcome was response rate (defined as ≥50% reduction in depressive symptoms measured by standardized ...
Fluoxetine: a review on evidence based medicine - PMC
Fluoxetine is effective in treating all degrees of depression and is clearly better tolerated (ie, has a more benign adverse-events profile) and safer in cases ...
SYMBYAX (olanzapine and fluoxetine hydrochloride) capsule
SYMBYAX — Safety and effectiveness ... The efficacy of SYMBYAX in acute treatment resistant depression was demonstrated with data from 3 clinical studies.
Fluoxetine (oral route) - Side effects & dosage
Fluoxetine is used to treat depression, obsessive-compulsive ... However, safety and efficacy have not been established to treat depression ...
SYMBYAX Safety and Utilization Review
• Pediatric Use: Safety and efficacy of Symbyax for the treatment of bipolar I depression in patients under 10 years of age have not been ...
Fluoxetine - StatPearls - NCBI Bookshelf
Fluoxetine is an FDA-approved medication that has demonstrated efficacy in treating a spectrum of psychological conditions.
Fluoxetine: MedlinePlus Drug Information
Children, teenagers, and young adults who take antidepressants to treat depression or other mental illnesses may be more likely to become suicidal.
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