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Repeated Intranasal Esketamine Plus Almond Therapy in Participants With Treatment Resistant Depressive Disorder – 3 Month Extension Study (ZYL-730-02)

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Single-blind, randomised, parallel extension (withdrawn) assessing maintenance of improvement over 3 months (n=0) with intranasal esketamine (56 or 84 mg, 8 doses) plus Almond Therapy versus esketamine plus treatment as usual in participants with TRD.

Details

This 3-month extension randomised study compares intranasal esketamine (56 or 84 mg according to Product Monograph; 8 administrations over 3 months) plus Almond Therapy versus esketamine plus treatment as usual in participants previously enrolled in ZYL-730-01.

Almond Therapy comprises up to 12 remote sessions tailored to participants plus supportive text messages; participants also receive up to 9 in-person visits and remote MADRS assessments by an independent assessor.

Topics:Treatment-Resistant Depression (TRD)

Registry

Registry linkNCT05438758