CompletedPhase 4ketamine

Intra-nasal vs. Intra-venous Ketamine Administration

Sponsored by Shalvata Mental Health Center

NCT ID
NCT02644629
Target Enrollment
45 participants
Start Date
2016-04
Est. Completion
2020-05

About This Study

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.

Conditions Studied

Major Depressive Disorder

Interventions

  • Placebo
  • Ketamine (1st phase)
  • Ketamine (2st phase)

Eligibility

Age:18 Years - 65 Years
Healthy Volunteers:No
View full eligibility criteria
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.

Study Locations (1)

Shalvata MHC
Hod HaSharon, Israel

This trial is not recruiting

This study has completed enrollment. Check back for results or find similar trials.

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Data Source
ClinicalTrials.gov

Last updated from source

Intra-nasal vs. Intra-venous Ketamine Administration | Huxley