dizziness

dizziness was captured in 4 source papers (996/8102). Interpret this as a source-backed named-event summary, not a head-to-head safety comparison.

Esketamine Nasal Spray|365/1110| 32.9%| during treatment

Efficacy and Safety of Esketamine Nasal Spray in Patients with Treatment-Resistant Depression Who Completed a Second Induction Period: Analysis of the Ongoing SUSTAIN-3 Study

registry:efficacy-and-safety-of-esketamine-nasal-spray-in-patients-with-treatment-resista:NCT02782104:ctg-api

ClinicalTrials.gov adverse events: Dizziness 365/1110 (32.9%) in Esketamine Nasal Spray (OP/MA Phase).

Esketamine Nasal Spray|198/1110| 17.8%| during treatment

Efficacy and Safety of Esketamine Nasal Spray in Patients with Treatment-Resistant Depression Who Completed a Second Induction Period: Analysis of the Ongoing SUSTAIN-3 Study

registry:efficacy-and-safety-of-esketamine-nasal-spray-in-patients-with-treatment-resista:NCT02782104:ctg-api

ClinicalTrials.gov adverse events: Vertigo 198/1110 (17.8%) in Esketamine Nasal Spray (OP/MA Phase).

Esketamine Nasal Spray|95/458| 20.7%| during treatment

Efficacy and Safety of Esketamine Nasal Spray in Patients with Treatment-Resistant Depression Who Completed a Second Induction Period: Analysis of the Ongoing SUSTAIN-3 Study

headache

headache was captured in 6 source papers (680/3953). Interpret this as a source-backed named-event summary, not a head-to-head safety comparison.

Esketamine Nasal Spray|401/1110| 36.1%| during treatment

Efficacy and Safety of Esketamine Nasal Spray in Patients with Treatment-Resistant Depression Who Completed a Second Induction Period: Analysis of the Ongoing SUSTAIN-3 Study

registry:efficacy-and-safety-of-esketamine-nasal-spray-in-patients-with-treatment-resista:NCT02782104:ctg-api

ClinicalTrials.gov adverse events: Headache 401/1110 (36.1%) in Esketamine Nasal Spray (OP/MA Phase).

Arm not specified|n=95| 51.9%| during treatment

Long-term treatment with esketamine nasal spray in patients with treatment resistant depression: Results from the ESCAPE-LTE study

paper full text

Over the course of both ESCAPE-TRD and ESCAPE-LTE, the most common TEAEs reported by patients included headaches (n = 95; 51.9%), dizziness (n = 89; 48.6%) and nausea (n = 74; 40.4%; Fig.).

Esketamine Nasal Spray|70/458| 15.3%| during treatment

Efficacy and Safety of Esketamine Nasal Spray in Patients with Treatment-Resistant Depression Who Completed a Second Induction Period: Analysis of the Ongoing SUSTAIN-3 Study

registry:efficacy-and-safety-of-esketamine-nasal-spray-in-patients-with-treatment-resista:NCT02782104:ctg-api

ClinicalTrials.gov adverse events: Headache 70/458 (15.3%) in Esketamine Nasal Spray (IND Phase).

Placebo + Standard of care|26/113| 23%| during treatment

Effects of esketamine on patient-reported outcomes in major depressive disorder with active suicidal ideation and intent: a pooled analysis of two randomized phase 3 trials (ASPIRE I and ASPIRE II)

registry:effects-of-esketamine-on-patient-reported-outcomes-in-major-depressive-disorder-:NCT03097133:ctg-api

ClinicalTrials.gov adverse events: Headache 26/113 (23%) in Placebo + Standard of Care (SOC).

nausea

nausea was captured in 5 source papers (607/2157). Interpret this as a source-backed named-event summary, not a head-to-head safety comparison.

Esketamine Nasal Spray|356/1110| 32.1%| during treatment

Efficacy and Safety of Esketamine Nasal Spray in Patients with Treatment-Resistant Depression Who Completed a Second Induction Period: Analysis of the Ongoing SUSTAIN-3 Study

registry:efficacy-and-safety-of-esketamine-nasal-spray-in-patients-with-treatment-resista:NCT02782104:ctg-api

ClinicalTrials.gov adverse events: Nausea 356/1110 (32.1%) in Esketamine Nasal Spray (OP/MA Phase).

Esketamine Nasal Spray|82/458| 17.9%| during treatment

Efficacy and Safety of Esketamine Nasal Spray in Patients with Treatment-Resistant Depression Who Completed a Second Induction Period: Analysis of the Ongoing SUSTAIN-3 Study

registry:efficacy-and-safety-of-esketamine-nasal-spray-in-patients-with-treatment-resista:NCT02782104:ctg-api

ClinicalTrials.gov adverse events: Nausea 82/458 (17.9%) in Esketamine Nasal Spray (IND Phase).

Arm not specified|n=74| 40.4%| during treatment

Long-term treatment with esketamine nasal spray in patients with treatment resistant depression: Results from the ESCAPE-LTE study

paper full text

Over the course of both ESCAPE-TRD and ESCAPE-LTE, the most common TEAEs reported by patients included headaches (n = 95; 51.9%), dizziness (n = 89; 48.6%) and nausea (n = 74; 40.4%; Fig.).

Esketamine 84 mg|32/121| 26.4%| during treatment

Esketamine Monotherapy in Adults With Treatment-Resistant Depression: A Randomized Clinical Trial

registry:esketamine-monotherapy-in-adults-with-treatment-resistant-depression-a-randomize:NCT04599855:ctg-api

ClinicalTrials.gov adverse events: Nausea 32/121 (26.4%) in DB: Esketamine 84 mg.

paresthesia

paresthesia was captured in 3 source papers (499/7200). Interpret this as a source-backed named-event summary, not a head-to-head safety comparison.

Esketamine Nasal Spray|102/1110| 9.20%| during treatment

Efficacy and Safety of Esketamine Nasal Spray in Patients with Treatment-Resistant Depression Who Completed a Second Induction Period: Analysis of the Ongoing SUSTAIN-3 Study

registry:efficacy-and-safety-of-esketamine-nasal-spray-in-patients-with-treatment-resista:NCT02782104:ctg-api

ClinicalTrials.gov adverse events: Hypoaesthesia 102/1110 (9.2%) in Esketamine Nasal Spray (OP/MA Phase).

Esketamine Nasal Spray|92/1110| 8.30%| during treatment

Efficacy and Safety of Esketamine Nasal Spray in Patients with Treatment-Resistant Depression Who Completed a Second Induction Period: Analysis of the Ongoing SUSTAIN-3 Study

registry:efficacy-and-safety-of-esketamine-nasal-spray-in-patients-with-treatment-resista:NCT02782104:ctg-api

ClinicalTrials.gov adverse events: Paraesthesia 92/1110 (8.3%) in Esketamine Nasal Spray (OP/MA Phase).

Esketamine Nasal Spray|83/1110| 7.50%| during treatment

Efficacy and Safety of Esketamine Nasal Spray in Patients with Treatment-Resistant Depression Who Completed a Second Induction Period: Analysis of the Ongoing SUSTAIN-3 Study

registry:efficacy-and-safety-of-esketamine-nasal-spray-in-patients-with-treatment-resista:NCT02782104:ctg-api

ClinicalTrials.gov adverse events: Hypoaesthesia Oral 83/1110 (7.5%) in Esketamine Nasal Spray (OP/MA Phase).

Esketamine Nasal Spray|69/1110| 6.20%| during treatment

Efficacy and Safety of Esketamine Nasal Spray in Patients with Treatment-Resistant Depression Who Completed a Second Induction Period: Analysis of the Ongoing SUSTAIN-3 Study

registry:efficacy-and-safety-of-esketamine-nasal-spray-in-patients-with-treatment-resista:NCT02782104:ctg-api

ClinicalTrials.gov adverse events: Paraesthesia Oral 69/1110 (6.2%) in Esketamine Nasal Spray (OP/MA Phase).

dissociation

dissociation was captured in 6 source papers (494/2157). Interpret this as a source-backed named-event summary, not a head-to-head safety comparison.

Esketamine Nasal Spray|272/1110| 24.5%| during treatment

Efficacy and Safety of Esketamine Nasal Spray in Patients with Treatment-Resistant Depression Who Completed a Second Induction Period: Analysis of the Ongoing SUSTAIN-3 Study

registry:efficacy-and-safety-of-esketamine-nasal-spray-in-patients-with-treatment-resista:NCT02782104:ctg-api

ClinicalTrials.gov adverse events: Dissociation 272/1110 (24.5%) in Esketamine Nasal Spray (OP/MA Phase).

Esketamine Nasal Spray|100/458| 21.8%| during treatment

Efficacy and Safety of Esketamine Nasal Spray in Patients with Treatment-Resistant Depression Who Completed a Second Induction Period: Analysis of the Ongoing SUSTAIN-3 Study

registry:efficacy-and-safety-of-esketamine-nasal-spray-in-patients-with-treatment-resista:NCT02782104:ctg-api

ClinicalTrials.gov adverse events: Dissociation 100/458 (21.8%) in Esketamine Nasal Spray (IND Phase).

Arm not specified|n=43| 23.5%| during treatment

Long-term treatment with esketamine nasal spray in patients with treatment resistant depression: Results from the ESCAPE-LTE study

paper full text

TEAEs of special interest were reported in 126 (68.9%) patients; the most common being dizziness (n = 89; 48.6%), dissociation (n = 43; 23.5%) and somnolence (n = 34; 18.6%; Fig.).

Esketamine 84 mg|32/121| 26.4%| during treatment

Esketamine Monotherapy in Adults With Treatment-Resistant Depression: A Randomized Clinical Trial

registry:esketamine-monotherapy-in-adults-with-treatment-resistant-depression-a-randomize:NCT04599855:ctg-api

ClinicalTrials.gov adverse events: Dissociation 32/121 (26.4%) in DB: Esketamine 84 mg.

nasal discomfort

nasal discomfort was captured in 2 source papers (405/3249). Interpret this as a source-backed named-event summary, not a head-to-head safety comparison.

Esketamine Nasal Spray|267/1110| 24.1%| during treatment

Efficacy and Safety of Esketamine Nasal Spray in Patients with Treatment-Resistant Depression Who Completed a Second Induction Period: Analysis of the Ongoing SUSTAIN-3 Study

registry:efficacy-and-safety-of-esketamine-nasal-spray-in-patients-with-treatment-resista:NCT02782104:ctg-api

ClinicalTrials.gov adverse events: Nasopharyngitis 267/1110 (24.1%) in Esketamine Nasal Spray (OP/MA Phase).

Esketamine Nasal Spray|93/1110| 8.40%| during treatment

Efficacy and Safety of Esketamine Nasal Spray in Patients with Treatment-Resistant Depression Who Completed a Second Induction Period: Analysis of the Ongoing SUSTAIN-3 Study

registry:efficacy-and-safety-of-esketamine-nasal-spray-in-patients-with-treatment-resista:NCT02782104:ctg-api

ClinicalTrials.gov adverse events: Nasal Discomfort 93/1110 (8.4%) in Esketamine Nasal Spray (OP/MA Phase).

Esketamine Nasal Spray|23/458| 5%| during treatment

Efficacy and Safety of Esketamine Nasal Spray in Patients with Treatment-Resistant Depression Who Completed a Second Induction Period: Analysis of the Ongoing SUSTAIN-3 Study

registry:efficacy-and-safety-of-esketamine-nasal-spray-in-patients-with-treatment-resista:NCT02782104:ctg-api

ClinicalTrials.gov adverse events: Nasal Discomfort 23/458 (5%) in Esketamine Nasal Spray (IND Phase).

Esketamine Nasal Spray|13/458| 2.80%| during treatment

Efficacy and Safety of Esketamine Nasal Spray in Patients with Treatment-Resistant Depression Who Completed a Second Induction Period: Analysis of the Ongoing SUSTAIN-3 Study

registry:efficacy-and-safety-of-esketamine-nasal-spray-in-patients-with-treatment-resista:NCT02782104:ctg-api

ClinicalTrials.gov adverse events: Nasopharyngitis 13/458 (2.8%) in Esketamine Nasal Spray (IND Phase).

Event	Aggregate count	Rate	Papers	Source terms
dizziness	996/8102	12.3%	4	Dizziness, Vertigo, dizziness
headache	680/3953	17.2%	6	Headache, headache, headaches
nausea	607/2157	28.1%	5	Nausea, nausea
paresthesia	499/7200	6.93%	3	Hypoaesthesia, Paraesthesia
dissociation	494/2157	22.9%	6	Dissociation, dissociation
nasal discomfort	405/3249	12.5%	2	Nasal Discomfort, Nasopharyngitis
somnolence

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Esketamine for Depressive Disorders: adverse events

How to read this summary

Most commonly reported named events

dizziness

Limitations

Source papers

headache

nausea

paresthesia

dissociation

nasal discomfort