TMU Call Minutes 06/10/2008
Present
Columbia: Marlene Carlson and Fred Jarskog
Duke: Rich Keefe and Joe McEvoy
MGH/BIDMC (Harvard): Don Goff and Lisa Raeke
MPRC: Bob Buchanan, Bernie Fischer, Bob McMahon, and Chris Wells
NIMH: Adam Haim and Ellen Stover
NKI: Rosemary Coslit, Jim Robinson, and Connie Shope
UCLA: Ayala Ofek
Wash. U.: Deanna Barch and Jim Galvin
Action Items
Merck
All sites – Submit polypharm amendment to IRBs. *Do not recruit with new criteria until after FDA approval (30days).
Allon
Nothing to report
Epix
Nothing to report
Novartis
Nothing to report
All Protocols
Nothing to report
Site Monitoring Visit
Nothing to report
Notes
Merck
NIMH DSMB
Merck was approved
1 to 2 2nd generation antipsychotics are acceptable
Amendment was submitted to FDA last week (S. Marder)
Sites should begin submittal process (Language sent out to site coordinators, P. Ball)
Do not recruit until after FDA approves (30 days)
No other issues reported
Allon
No study related issues reported
Contract ending in August
Budget roll-over discussed
Epix
Nothing to report
Novartis
fMRI
- Novartis and D. Barch met on 06/09
- Some tasks may be removed to reduce costs
- CRO may be used for image QA
oThought that 3rd party analyst may relieve burdens for study personnel to focus on other aspects of study
oPlans was not deemed as cost effective
Protocol revisions
- Currently includes phases 1 and 2, however study design may change
oInterim data set will be produced/analyzed before proceeding to phase 2
oPhases 1 and 2 may be submitted as separate protocols
oStudy may proceed as original fMRI protocol
- Summary
oPhase 1 (single dose) Phase 2 (Multi-dose)
oResults from phase one used to determine dosages used in phase 2
oCan be done if following are know: Half-life, absorption rate, metabolite kinetics
- WTAR
oWill be used since 5th grade reading level required
- Polypharmacy
oWe are O.K. with 2 or more second generation antipsychotics
- Male birthcontrol
oNovartis requires use of two forms and up to 3 months after participating in study
oPropose change to…if subject agrees to use “adequate methods”…
- Concomitant Medication
o3a4, 2d6, 1a2 inhibitors, SSRIs, low dose chronic anxiolytics, will be allowed
oanti-epileptics ok (Neurotonin, lithium < 0.8)
ono Pan-inducers (Dilantin, depakote)
oGalantamine and varenicline should not be allowed
oSee appendix 3 for drug list
- Smoking
o3:1 ratio for population
oPropose expired CO to be used to determine smoking status (10ppm cut-off)
- Pharmacological Kinetics
oAll day event
oSubjects should be compensated for extra time involved with testing
- Phase 2
oDesigned to collect primarily for collection of safety data
oAssessment schedule reviewed
- Inclusion/Exclusion Criteria (p.8/9)
oVitals ranges ok’d
oBody temp may be removed
oPulse rate may need adjustment
oBMI needs to be raised above 30
oOrthostatic hypotension measurement not necessary
oSGPT within normal range criterion too strict
NKI will conduct data collection
- Protocol under review
- AE and SAEs procedure will require further discussion
- Novartis CRF will be used
All Protocols
Nothing to report
Site Monitoring Visit
Nothing to report
Next Coordinators call: June 17, 2008
Next TMU call: June 24, 2008