Intra-nasal vs. Intra-venous Ketamine Administration

Shalvata Mental Health Center

Status and phase: Completed; Phase 4

Conditions: Major Depressive Disorder

Treatments: Drug: Ketamine (1st phase); Drug: Ketamine (2st phase); Drug: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT02644629

SHA-15-0019

Details and patient eligibility

About

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.

Enrollment: 45 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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45 participants in 2 patient groups

Active IV

Active Comparator group

Description:

Will receive IV Ketamine, along with IN placebo.

Treatment:

Drug: Placebo

Drug: Ketamine (2st phase)

Drug: Ketamine (1st phase)

Active IN

Active Comparator group

Description:

Will receive IN Ketamine, along with IV placebo.

Treatment:

Drug: Placebo

Drug: Ketamine (2st phase)

Drug: Ketamine (1st phase)