NCT03201757Phase 3Completed

Study to Evaluate the Long-term Safety, Tolerability, and Durability of Treatment Effect of ALKS 3831

Compare the available registry edits below. Primary completion is the date data collection ends for the main study measures; it does not tell you when results will be published.

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Primary completion2023-09-06Actual

Enrollment · participants523Actual

Source updated2024-09-26Last update listed in the registry record

Version history

Changes to this trial

Last 12 months

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No recorded changes are available for this view and time period. Our history may be incomplete; this does not establish that the trial stayed unchanged.

Study details

Conditions studied

Schizophrenia; Schizophreniform Disorder; Bipolar I Disorder

Treatments or interventions studied

ALKS 3831Drug

Primary outcomes · main study measures

Read the study measures

measure: Incidence of Adverse Events; timeFrame: Up to 48 months; measure: Change From Baseline in Clinical Global Impression-Severity (CGI-S) Scale; description: The clinical global impression - severity scale (CGI-S) is a 7-point scale that requires the clinician to rate the severity of the patient's illness at the time of assessment, relative to the clinician's past experience with patients who have the same diagnosis; 1 being normal, not ill at all and 7 being among the severally ill patients; timeFrame: Up to 48 months

History coverage

Research sample: selected versions from May 2023 onward plus a preceding baseline where available. Only selected fields were retained; endpoint measures were truncated to 300 characters. This is not complete trial or sponsor history. Daily snapshots begin when collection starts.

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