Status:
NOT_YET_RECRUITING
Evaluation of the Efficacy and Safety of Subcutaneous Ketamine in the Treatment of Depressive Episode With Suicidal Ideation and/or Behavior in Adolescents
Lead Sponsor:
Federal University of São Paulo
Conditions:
Depressive Disorder
Suicidal Ideas
Eligibility:
All Genders
12-19 years
Phase:
PHASE3
Brief Summary
Evaluate the efficacy and safety of subcutaneous ketamine added to usual treatment in the management of depressive episodes with suicidal ideation or behavior in adolescent patients, compared to usual...
Detailed Description
Depression affects approximately 8% of adolescents, with an estimated 60% showing inadequate response to current standard treatments. Ketamine, a glutamatergic modulator, has demonstrated efficacy in ...
Eligibility Criteria
Inclusion
- Age between 12 and 19 years.
- Diagnosis of Major Depressive Episode, unipolar, made through the Schedule for Affective Disorders and Schizophrenia for School-Age Children (K-SADS-PL) administered by experienced evaluators, using DSM-5 criteria.
- Under usual treatment for Major Depressive Episode, including clinically indicated psychopharmacological treatment and/or psychosocial treatment at one of the two collaborating clinics (DICA and Conversas de Vida / Unifesp).
- Score ≥ 25 on the MADRS (Montgomery-Åsberg Depression Rating Scale).
- Score ≥ 28 on the CDRS (Children Depression Rating Scale).
- Score ≥ 2 on the Columbia Suicide Severity Rating Scale (C-SSRS).
- History of suicide attempt or significant suicidal ideation or planning with a plan or intention requiring emergency evaluation in the last 30 days.
Exclusion
- Presence of the following psychiatric comorbidities: Autism Spectrum Disorder, Bipolar Disorder, Schizophrenia, Schizoaffective Disorder, or psychiatric disorder secondary to physical illness, and history of ketamine or other substance abuse or dependence in the last 6 months.
- Presence of Intellectual Disability (assessed by IQ testing).
- Presence of the following clinical comorbidities: history of myocardial infarction, congenital heart disease, decompensated cardiac arrhythmia, decompensated hypertension, porphyria, stroke, brain trauma with loss of consciousness, intracranial hypertension, hydrocephalus, central nervous system tumors, or central nervous system abnormalities.
- Previous treatment for depression with esketamine.
- Allergy to esketamine.
- If female: pregnancy or breastfeeding.
Key Trial Info
Start Date :
May 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 1 2028
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT06957704
Start Date
May 1 2025
End Date
April 1 2028
Last Update
May 4 2025
Active Locations (0)
Enter a location and click search to find clinical trials sorted by distance.
No Results Found
We couldn’t find results for the location/zipcode entered or within the selected range. Please check your input or adjust your search.