Study to Evaluate Effect of AMG 747 on Schizophrenia Negative Symptoms

• Research type

  Research Study

• Full title

  A Phase 2, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Effect of Add-on AMG 747 on Schizophrenia Negative Symptoms (Study 165)

• IRAS ID

  98929

• Contact name

  Ashley Baldwin

• Sponsor organisation

  Amgen Inc.

• Eudract number

  2011-004845-42

• Research summary

  The purpose of this study is to find out whether AMG 747 can improve the negative symptoms of schizophrenia. To do this, AMG 747 will be compared to placebo over the course of 12 weeks. The placebo will look like AMG 747 but it will not contain active ingredients. Taking placebo is the same as not taking anything for schizophrenia. Participants will be randomized into one of 4 groups: placebo, AMG 747 5 mg, AMG 747 15 mg, or AMG 747 40 mg. Randomized means they are put into a group by chance. It is like drawing a number out of a hat. Participants will have about a 33% (1 in 3) chance of being placed in the placebo group, and about a 66% (2 in 3) chance of being placed in one of the AMG 747 groups (i.e. a 22% chance of being placed in the AMG 747 5 mg group; a 22% chance of being placed in the AMG 747 15 mg group; and a 22% chance of being placed in the AMG 747 40 mg group). AMG 747 will be given in addition to the participants current antipsychotic therapy (i.e. it will be an add-on therapy). Participants will not have to change or stop any of their ongoing antipsychotic therapy. The effect AMG 747 has on negative symptoms will be assessed using patient interviews (also known as rating scales) at set timepoints throughout the study. The primary rating scale that will be used is the Negative Symptom Assessment Scale (NSA-16).

• REC name

  North West - Liverpool Central Research Ethics Committee

• REC reference

  12/NW/0296

• Date of REC Opinion

  30 May 2012

• REC opinion

  Further Information Favourable Opinion