Efficacy And Tolerability Of Sub-Anesthetic Ketamine In Postpartum Depression

The purpose of this study is to assess the safety, pharmacokinetics and antidepressant efficacy of sub-anesthetic dose of intravenous ketamine in perinatal depression.

Topic Postpartum Depression Depression
Compound Placebo Ketamine
Country United States of America
Visit trial
Status Terminated
Results Published No
Start date 03 April 2019
End date 09 September 2019
Chance of happening 0%
Phase Phase II
Design Blinded
Type Interventional
Generation First
Participants 1
Sex All
Age 18- 45
Therapy No

Trial Details

Postpartum depression is a non-psychotic major or minor depressive episode that occurs during pregnancy or within 12 months of post-partum period. The nature of symptoms is same as depressive episode characterized by depressed mood, anxiety, sleep difficulties, suicidal thoughts, tiredness and diminished interest in pleasurable activities. Severe maternal depression affects children by increasing the risk of emotional and behavioral and physical health problems and cognitive difficulties. Thus early screening and intervention is critical in reducing the negative impact of PND in the mother and child, family and the community.

NCT Number NCT04011592

Sponsors & Collaborators

The University of Texas Health Science Center
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Measures Used

Hamilton Depression Rating Scale
The Hamilton Depression Rating Scale (HDRS) is a multiple item questionnaire used to provide an indication of depression, and as a guide to evaluating recovery. The scale consists of 17 items which each item being scoring on a 3 or 5 point scale. The higher the score, the more likely a person is depressed.

Patient Health Questionnaire for Depression
The PHQ-9 is the module of the Patient Health Questionnaire focusing on major depressive disorder (MDD). It is a 3-page questionnaire that can be entirely self-administered by the patient, after which it is checked by a medical professional. The PHQ-9 consists of 9 items. If 5 or more criteria have been met, the patient is diagnosed with depression.

Columbia-Suicide Severity Rating Scale
The Columbia-Suicide Severity Rating Scale (CSSRS) is a suicidal ideation and behaviour rating scale created by researchers at Columbia University, University of Pennsylvania, University of Pittsburgh and New York University to evaluate suicide risk

Data attribution

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