Major Depressive Disorder Clinical Trial
Official title:
Intra-nasal vs. Intra-venous Ketamine Administration as an add-on to Antidepressant Therapy
NCT number | NCT02644629 |
Other study ID # | SHA-15-0019 |
Secondary ID | |
Status | Completed |
Phase | Phase 4 |
First received | |
Last updated | |
Start date | April 2016 |
Est. completion date | May 2020 |
Verified date | October 2020 |
Source | Shalvata Mental Health Center |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The current study wishes to contribute to the applicability of the use of ketamine in a clinical setting by focusing on the efficacy of intra-nasal administration compared with the IV route.
Status | Completed |
Enrollment | 45 |
Est. completion date | May 2020 |
Est. primary completion date | May 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 65 Years |
Eligibility | Inclusion Criteria: 1. Age 18-65 2. Diagnosis of MDD (Major Depressive Disorder), made or affirmed by a senior psychiatrist in Shalvata 3. MADRS score > 20 4. Treated with conventional anti-depressant, administered within a formal psychiatric clinic or by a certified psychiatrist. Exclusion Criteria: 1. Active or past psychotic disorder, including a history of psychotic affective state 2. Mental Retardation or Autistic Spectrum Disorder 3. Prominent personality disorder 4. Cardiac or neurologic active medical condition, including past CVA/TIA (Cardiovascular Accident/Transient Ischemic Attack) or any other unstable medical condition. 5. Chronic nasal congestion 6. Active or recent drug or alcohol abuse 7. Substantial suicidality in a patient requiring admission but refuses to do so, and signs an "against medical advice" release form as part of clinical evaluation, and does not answer the terms for involuntary admission. |
Country | Name | City | State |
---|---|---|---|
Israel | Shalvata MHC | Hod Hasharon |
Lead Sponsor | Collaborator |
---|---|
Shalvata Mental Health Center |
Israel,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | MADRS (Montgomery-Åsberg Depression Rating Scale) score improvement from baseline | 15 weeks | ||
Secondary | Ratio of subjects achieving remission | 15 weeks | ||
Secondary | Ratio of subjects achieving Response | 15 weeks | ||
Secondary | Durability of anti-depressant effect according to MADRS Score | The rate of effect decline, as measured by MADRS Questionnaire | 15 weeks | |
Secondary | Tolerability of Route, based on side effects questionnaire | Adverse side effects reported by subjects, as reported in side effects questionnaire | 3 weeks |
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