Either you have JavaScript disabled or your browser does not support Javascript . To work properly, this page requires JavaScript to be enabled.
How to enable JavaScript in your browser?

Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multi-Center Study to Assess the Efficacy and Safety of ITI-007 Monotherapy in the Treatment of Patients With Major Depressive Episodes Associated With Bipolar I or Bipolar II Disorder

Next Previous
Search
Trial Profile

Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multi-Center Study to Assess the Efficacy and Safety of ITI-007 Monotherapy in the Treatment of Patients With Major Depressive Episodes Associated With Bipolar I or Bipolar II Disorder

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 25 Nov 2022

Price :
$35 *
Note:
  • Adis is an information provider.
  • Final gross price and currency may vary according to local VAT and billing address.
  • Your purchase entitles you to full access to the information contained in our trial profile at the time of purchase.
  • A link to download a PDF version of the trial profile will be included in your email receipt.

At a glance

  • Drugs Lumateperone (Primary)
  • Indications Bipolar depression; Bipolar I disorders; Bipolar II disorders
  • Focus Registrational; Therapeutic Use
  • Sponsors Intra-Cellular Therapies

    • Most Recent Events

    • 18 Oct 2022 Results (n=127) of OLE period of this trial assessing long-term safety of lumateperone in patients with bipolar depression presented at the 35th Annual Congress of the European College of Neuropsychopharmacology
    • 13 Jun 2022 According to a Intra-Cellular Therapies media release, results of pooled analysis of study 404 and 401 presented at the 2022 International Society for Bipolar Disorders (ISBD)
    • 13 Jun 2022 Results of pooled analysis of study 404 and 401 published in the Intra-Cellular Therapies Media Release

You need to be a logged in or subscribed to view this content Request demo

If your organization or you do not have a subscription, try one of the following:
  • Contacting your organization’s admin about adding this content to your AdisInsight subscription
  • Buying a PDF version of any individual profile
  • Request a free trial
If your organization has a subscription, there are several access options, even while working remotely:
  • Working within your organization’s network
  • with username/password or try to via your institution
  • Persisted access using your organization’s identifier stored in your user browser for 90 days
Back to top