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Completed

NCT Number: NCT02644629

Intra-nasal vs. Intra-venous Ketamine Administration

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.

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Key information

Conditions

Major Depressive Disorder Depressive Disorder Depressive Disorder, Major Mental Disorders Mood Disorders

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Shalvata MHC

Hod HaSharon, POB 94, Israel

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age 18-65
  • Diagnosis of MDD (Major Depressive Disorder), made or affirmed by a senior psychiatrist in Shalvata
  • MADRS score > 20
  • Treated with conventional anti-depressant, administered within a formal psychiatric clinic or by a certified psychiatrist.

Exclusion criteria

  • Active or past psychotic disorder, including a history of psychotic affective state
  • Mental Retardation or Autistic Spectrum Disorder
  • Prominent personality disorder
  • Cardiac or neurologic active medical condition, including past CVA/TIA (Cardiovascular Accident/Transient Ischemic Attack) or any other unstable medical condition.
  • Chronic nasal congestion
  • Active or recent drug or alcohol abuse
  • 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.

Treatment and study plan

Placebo

Drug

Saline 0.9%, Administration of 0.2mg/kg (IV Push) or 50mg (IN, 5 doses, alternating nostrils)

Other names: Saline 0.9%

Ketamine (1st phase)

Drug

Administration of 0.2mg/kg (IV Push) or 50mg (IN, 5 doses, alternating nostrils)

Other names: Ketalar

Ketamine (2st phase)

Drug

Patients failing to achieve response (<50% MADRS score) in the parallal phase, will be offered additional 4 session (twice a week, 2 weeks) of 0.5 mg/kg ketamine over 40 minutes.

Other names: Ketalar

Primary outcomes

  1. MADRS (Montgomery-Åsberg Depression Rating Scale) score improvement from baseline

    Time frame: 15 weeks

Secondary outcomes

  1. Ratio of subjects achieving remission

    Time frame: 15 weeks

  2. Ratio of subjects achieving Response

    Time frame: 15 weeks

  3. Durability of anti-depressant effect according to MADRS Score

    Time frame: 15 weeks

    The rate of effect decline, as measured by MADRS Questionnaire

  4. Tolerability of Route, based on side effects questionnaire

    Time frame: 3 weeks

    Adverse side effects reported by subjects, as reported in side effects questionnaire

Sponsors and collaborators

Lead sponsor

Shalvata Mental Health Center

Other

Registry information

Official study title

Intra-nasal vs. Intra-venous Ketamine Administration as an add-on to Antidepressant Therapy

Important dates

Study start
2016
Primary completion
2020
Study completion
2020
First posted
Jan 1, 2016
Registry last updated
Oct 28, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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