Schizophrenia.com

Intra-Cellular Therapies Presents Additional ITI-007 Data at the 5th Biennial Schizophrenia International Research Society (SIRS) Conference

http://ir.intracellulartherapies.com/releasedetail.cfm?ReleaseID=963729

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Gud news… but its release date iz still unknown

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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?

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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.

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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.

ongoing trial

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Hi

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!

Hippo

Schizophrenia
Drug: ITI-007
Drug: Risperidone
Drug: Placebo
Phase 3

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.