Ketamine for Adult Depression Study

Phase 3

Completed

• Conditions: Major Depressive Disorder; Mental Health - Depression

• Registration Number: ACTRN12616001096448
• Lead Sponsor: niversity of New South Wales

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2016-08-12
• Study Completion: 2020-05-07
• Last Update Posted: 8 November 2021

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 183

Inclusion Criteria

Criteria assessed by the research team include:
-Major Depressive Disorder (MDD) for at least 3 months.
-An inadequate response to at least 2 adequate antidepressants courses. Stable dose of antidepressant medications at least 4 weeks prior to trial entry.
-Montgomery Asberg Depression Rating Scale (MADRS) score of at least 20.

Exclusion Criteria

Criteria assessed by the research team to determine suitability include:
- Psychotic disorder.
- Bipolar disorder.
-Medical and neurologic conditions.
-Psychiatric disorders other than MDD.
-Planned major changes to psychotropic medication.
-Planned or probable use of ECT.
-Risk of suicide.
-Substance use, abuse, dependence.
-Recent or planned ketamine treatment.
-Medical conditions in which use of ketamine or sedating medications may pose a significant health risk.
-Women of childbearing potential not taking reliable contraception.
- inability to complete the trial

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Remission at end of RCT phase (score <10 on MADRS)[4 weeks post randomisation (End of RCT phase)<br>8 weeks post randomisation (4 week follow up)<br>12 weeks post randomisation (8 week follow up)]