Gud news… but its release date iz still unknown
So it past clinical trials. This is amazing as I was worried it might not even pass. I’m so glad now we just have to wait for their application.
I just noticed they removed the fact that it doesn’t cause weight gain. Does this mean it actually causes weight gain after all?
I think this presentation is about the first Phase 3 trial, not the ongoing Phase 3 trial.
The ongoing trial is a bit longer and compares ITI-007 with Risperdal.
I don’t think your right. They even took no weight gain off as a benefit.
This is the ongoing trial, hopefully the last one.
On the clinical trials website. The estimated completiion date is August 2016. primary completion May 2016…below copied from the clinical trials site…
I am so praying this will be a low weight gainer!
Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized, Double-Blind, Placebo- and Active-Controlled, Multi-Center Study to Assess the Antipsychotic Efficacy of ITI-007 After 6 Weeks of Treatment in Patients With Schizophrenia
Resource links provided by NLM:
MedlinePlus related topics: Schizophrenia
Drug Information available for: Risperidone
U.S. FDA Resources
Further study details as provided by Intra-Cellular Therapies, Inc.:
Primary Outcome Measures:
Positive and Negative Syndrome Scale Total Score [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
Positive and Negative Syndrome Scale Subscales [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
Estimated Enrollment: 580
Study Start Date: June 2015
Estimated Study Completion Date: August 2016
Estimated Primary Completion Date: May 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 20 mg ITI-007
Good there’s still hope it has no weigh gain.