CLINICAL TRIALS PROFILE FOR SPRAVATO
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All Clinical Trials for spravato
| Trial ID | Title | Status | Sponsor | Phase | Start Date | Summary |
|---|---|---|---|---|---|---|
| NCT05268497 ↗ | A Study to Assess Feasibility of Using Clinician-directed and Digital Application Supported Cognitive Behavior Therapy (CBT) in Conjunction With Esketamine in Participants With Treatment-resistant Depression | Not yet recruiting | Janssen Research & Development, LLC | Phase 1 | 2022-03-14 | The purpose of this study is to explore feasibility of combining clinician-directed cognitive behavioral therapy (CBT) supplemented with the Mindset app with esketamine therapy in participants with Treatment-resistant Depression. |
| NCT05323019 ↗ | Repeated Intranasal Esketamine Plus Almond Therapy in Patients With Treatment Resistant Depression | Not yet recruiting | Zylorion Health | Phase 2 | 2022-05-01 | To examine the efficacy of Almond Therapy compared to Treatment as Usual when used in addition to an approved version of intranasal esketamine. |
| NCT05554627 ↗ | VA Aripiprazole vs Esketamine for Treatment Resistant Depression | Not yet recruiting | VA Office of Research and Development | Phase 4 | 2023-03-01 | This is an open-label, parallel-group, randomized clinical trial of up to 6 months treatment of adjunctive intranasal (IN) esketamine (ESK) vs. adjunctive aripiprazole (ARI) in Veterans with unipolar Treatment Resistant Depression (TRD). This study will assess the efficacy, safety, and acceptability of adjunctive IN ESK in comparison to ARI, one of the best studied and most widely used adjunctive therapies for TRD. The primary hypothesis is that participants receiving adjunctive IN ESK will be significantly more likely to achieve remission after six weeks of treatment as compared to those who receive adjunctive ARI. Depressive symptoms will be assessed by central raters (CR), blinded to treatment assignment, using the clinician rated version of the Quick Inventory of Depressive Symptomatology (QIDS-C16), a well-validated tool that is commonly used and is easily translated across other depression inventory scales. The study is powered to detect an absolute difference in remission rates of 10%, or larger, at 6 weeks. Additional outcomes of interest include symptom reduction across 6 months of randomized therapy, side effects and other tolerability indices, attrition rates and measures of quality of life and cost-effectiveness. |
| NCT06103760 ↗ | Positioning of Esketamine Treatment in the Real-world Management of Depression | Recruiting | Janssen-Cilag Pty Ltd | Phase 4 | 2023-10-31 | The goal of this naturalistic, open label, single arm intervention study is to investigate the effects of Esketamine in treating depression.The main aims to answer are: - to investigate whether Esketamine is effective when added to ongoing antidepressant treatment - to identify patient characteristics that will determine a therapeutic response to Esketamine in real-world practice Participants will: - attend the clinic for supervised self-administration of intranasal Esketamine treatment - be observed for 2 hours following Esketamine administration including blood pressure monitoring - be asked to complete a battery of questionnaires - be reimbursed for travel expenses |
| NCT06103760 ↗ | Positioning of Esketamine Treatment in the Real-world Management of Depression | Recruiting | Royal North Shore Hospital | Phase 4 | 2023-10-31 | The goal of this naturalistic, open label, single arm intervention study is to investigate the effects of Esketamine in treating depression.The main aims to answer are: - to investigate whether Esketamine is effective when added to ongoing antidepressant treatment - to identify patient characteristics that will determine a therapeutic response to Esketamine in real-world practice Participants will: - attend the clinic for supervised self-administration of intranasal Esketamine treatment - be observed for 2 hours following Esketamine administration including blood pressure monitoring - be asked to complete a battery of questionnaires - be reimbursed for travel expenses |
| >Trial ID | >Title | >Status | >Sponsor | >Phase | >Start Date | >Summary |
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