Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 11:38 PM
Ignite Modification Date:
2025-12-24 @ 11:38 PM
NCT ID:
NCT02129751
Brief Summary:
Double-Blind, Placebo-Controlled, Multicenter Study of Efficacy and Safety
Detailed Description:
* The primary efficacy endpoint is the mean change from Baseline to EOT in total CDRS-R (raw) score.
* The secondary efficacy endpoints include:
* Proportion of subjects characterized as responders at EOT (≥40% improvement from Baseline total CDRS-R raw score)
* Proportion of subjects characterized as in remission at EOT (total CDRS-R raw score \<29)
* Mean change from Baseline to EOT in CGI-C.
Safety endpoints include:
* Incidence of AEs
* Change from Baseline to EOT in vital signs (blood pressure and radial pulse rate), blood and urine laboratory panel, and ECG
* Treatment discontinuation due to AEs
* Suicidality as assessed by the C-SSRS score
* Change from Baseline to EOT in sleep as assessed by the sleep subscale of the CDRS-R.
Study:
NCT02129751
Study Brief:
Protocol Section:
NCT02129751