Effect of oral ketamine at doses of 1 and 2 mg/kg on depression treatment

Phase 2

• Conditions: Treatment-Resistant Major Depressive Disorder.; Major depressive disorder, recurrent, unspecified; F33.9

• Registration Number: IRCT20090801002266N14
• Lead Sponsor: Esfahan University of Medical Sciences

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 15 June 2020

Recruitment & Eligibility

• Status: Pending
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

Age between 60-18 years
Individual who have DSM-V indicators for major depression without psychotic characteristics and mania or hypomania
Individual who do not have an adequate response to monotherapy with antidepressants for at least two times (at least 4-6 weeks)
No history of mania / hypomania
Lack of psychotic symptoms
Satisfaction with participating in the study

Exclusion Criteria

History of drug dependence or abuse in the last 3 months
Pregnant or lactating women
Serious and unstable physical patients including liver, kidney, gastrointestinal, respiratory, cardiovascular diseases (such as ischemic heart disease), endocrine, neurological, hematological.
Taking medications that are contraindicated with ketamine is prohibited
Untreated hypothyroidism or hyperthyroidism

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Depression score. Timepoint: The second week, the fourth week and the sixth week during the intervention and one week, one month and two months after the intervention. Method of measurement: Hamilton Depressive Rating Scale (HDRS) and Beck-2 Depression Questionnaire.

Secondary Outcome Measures

Name	Time	Method
Ketamin Side effects. Timepoint: The second week, the fourth week and the sixth week during the intervention and one week, one month and two months after the intervention. Method of measurement: checklist evaluation.