On this page you will find all the information and links relevant to the Ketamine Clinical Study.
Since 2000, research conducted through our organization has defined a behavioral profile which describes those children on the bipolar spectrum who are most severely affected by the illness. We call this profile the Fear of Harm (FOH) phenotype.
Since Oct. 2008, a pilot study has been conducted in which 60 children and young adults characterized by the FOH phenotype have been treated with intranasal ketamine. Almost all of them responded to treatment with a dramatic, but as yet unproven improvement in all symptoms primary to FOH. Behavioral data on 12 of those cases have been documented in a recently published paper (click here).
The Ketamine Clinical Study will be a formal test of the pilot study results. This new study has been approved by the BIOMED Internal Review Board and the Federal Drug Administration (FDA).
The following links provide comprehensive information regarding the study:
- Listen to the NPR interview on FOH and ketamine click here
- Discussion on the Use and Safety of Ketamine
- Paper for Professionals (Includes: Rational and Implementation of Study and the Use, Effects and Safety of Ketamine)
- Clinical Study Overview
- Frequently Asked Questions FAQ’s
- Criteria for Enrollment
- Day by Day Study Description
(The study is currently on hold as we incorporate insights gained during its initial run. Please join our mailing list in order to be notified when it starts up again.)
If this treatment study is important to you please support it by making a donation below. Every bit helps.
All donations made here directly fund the Ketamine Clinical Study. Expenses include staff, equipment, supplies, programming, analysis, insurance and regulation compliance.
The application and the Frequently Asked Questions provide a very thorough description of the Ketamine Clincial Study. If, after reading these, you still have questions, please contact us.