Evaluation of the Efficacy and Safety of Subcutaneous Ketamine in the Treatment of Depressive Episode With Suicidal Ideation and/or Behavior in Adolescents
NCT ID: NCT06957704
Last Updated: 2025-05-04
Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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Recruitment Status
NOT_YET_RECRUITING
Clinical Phase
PHASE3
Total Enrollment
60 participants
Study Classification
INTERVENTIONAL
Study Start Date
2025-05-31
Study Completion Date
2028-04-30
Brief Summary
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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 treatment added to placebo (midazolam).
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Detailed Description
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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 adults with treatment-resistant depression and has shown promising preliminary results in adolescent populations. This Phase III, randomized, double-blind, placebo-controlled clinical trial aims to evaluate the efficacy and safety of subcutaneous ketamine as an adjunctive treatment for adolescents experiencing a major depressive episode with active suicidal ideation and/or behavior.
Participants will be randomized into two parallel groups to receive either subcutaneous ketamine (0.5 to 1 mg/kg) or an active placebo (1 mg midazolam diluted in 5 ml of 0.9% saline), administered twice weekly for four weeks. All participants will continue their usual treatment regimens. A two-week post-treatment follow-up period will be conducted to assess the persistence of effects and monitor safety outcomes.
Clinical assessments include diagnostic and symptom severity scales validated for pediatric populations. The efficacy will be primarily measured by depression remission and response, while safety will be assessed via adverse event monitoring and clinical examination. The trial will include 30 participants per group, providing 80% power to detect a clinically significant difference of 8.7 points on the Montgomery-Åsberg Depression Rating Scale (MADRS) between groups.
Participants will be randomized into two parallel groups to receive either subcutaneous ketamine (0.5 to 1 mg/kg) or an active placebo (1 mg midazolam diluted in 5 ml of 0.9% saline), administered twice weekly for four weeks. All participants will continue their usual treatment regimens. A two-week post-treatment follow-up period will be conducted to assess the persistence of effects and monitor safety outcomes.
Clinical assessments include diagnostic and symptom severity scales validated for pediatric populations. The efficacy will be primarily measured by depression remission and response, while safety will be assessed via adverse event monitoring and clinical examination. The trial will include 30 participants per group, providing 80% power to detect a clinically significant difference of 8.7 points on the Montgomery-Åsberg Depression Rating Scale (MADRS) between groups.
Conditions
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Depressive Disorder
Suicidal Ideas
Study Design
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Allocation Method
RANDOMIZED
Intervention Model
PARALLEL
Primary Study Purpose
TREATMENT
Blinding Strategy
DOUBLE
Participants
Outcome Assessors
Study Groups
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Ketamine
Participants were randomly by assigned. ketamine will be used as an adjunctive treatment at an initial dose of 0.5 mg/kg, administered subcutaneously twice weekly for four weeks under double-blind conditions. Dose adjustments between 0.5 to 1.0 mg/kg may occur based on patient response and tolerability.
Group Type
EXPERIMENTAL
ketamine
Intervention Type
DRUG
Ketamine will be administered as adjunctive therapy at an initial dose of 0.5 mg/kg via subcutaneous injection, twice weekly for four weeks, under double-blind conditions. Dose adjustments between 0.5 and 1.0 mg/kg will be based on depressive symptoms, efficacy, and tolerability. All procedures will occur at the Ketamine Clinic of Federal University of São Paulo.
Midazolam
For the placebo group, midazolam will be administered subcutaneously at a dose of 1 mg diluted in 5 ml of 0.9% saline, twice weekly for four consecutive weeks, also under double-blind conditions.
Group Type
PLACEBO_COMPARATOR
Midazolam
Intervention Type
DRUG
Midazolam will be administered subcutaneously twice weekly for four consecutive weeks, also under double-blind conditions. The subject will be monitored continuously during the procedure, and every hour for three hours after the infusion.
Interventions
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ketamine
Ketamine will be administered as adjunctive therapy at an initial dose of 0.5 mg/kg via subcutaneous injection, twice weekly for four weeks, under double-blind conditions. Dose adjustments between 0.5 and 1.0 mg/kg will be based on depressive symptoms, efficacy, and tolerability. All procedures will occur at the Ketamine Clinic of Federal University of São Paulo.
Intervention Type
DRUG
Midazolam
Midazolam will be administered subcutaneously twice weekly for four consecutive weeks, also under double-blind conditions. The subject will be monitored continuously during the procedure, and every hour for three hours after the infusion.
Intervention Type
DRUG
Eligibility Criteria
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Inclusion Criteria
* 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.
* 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 Criteria
* 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.
* 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.
Minimum Eligible Age
12 Years
Maximum Eligible Age
19 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
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Federal University of São Paulo
OTHER
Sponsor Role
lead
Responsible Party
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Sheila Cavalcante Caetano
Professor; Post doctor
Responsibility Role
PRINCIPAL_INVESTIGATOR
Central Contacts
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References
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Reference Type
BACKGROUND
Alnefeesi Y, Chen-Li D, Krane E, Jawad MY, Rodrigues NB, Ceban F, Di Vincenzo JD, Meshkat S, Ho RCM, Gill H, Teopiz KM, Cao B, Lee Y, McIntyre RS, Rosenblat JD. Real-world effectiveness of ketamine in treatment-resistant depression: A systematic review & meta-analysis. J Psychiatr Res. 2022 Jul;151:693-709. doi: 10.1016/j.jpsychires.2022.04.037. Epub 2022 May 25.
Reference Type
BACKGROUND
Abdallah CG, Jackowski A, Salas R, Gupta S, Sato JR, Mao X, Coplan JD, Shungu DC, Mathew SJ. The Nucleus Accumbens and Ketamine Treatment in Major Depressive Disorder. Neuropsychopharmacology. 2017 Jul;42(8):1739-1746. doi: 10.1038/npp.2017.49. Epub 2017 Mar 8.
Reference Type
BACKGROUND
Abbar M, Demattei C, El-Hage W, Llorca PM, Samalin L, Demaricourt P, Gaillard R, Courtet P, Vaiva G, Gorwood P, Fabbro P, Jollant F. Ketamine for the acute treatment of severe suicidal ideation: double blind, randomised placebo controlled trial. BMJ. 2022 Feb 2;376:e067194. doi: 10.1136/bmj-2021-067194.
Reference Type
BACKGROUND
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
82712924300005505
Identifier Type: -
Identifier Source: org_study_id
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