New Schizophrenia Drug Shows Promise In Phase II Human Trials

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Main Category: Schizophrenia
Also Included In: Clinical Trials / Drug Trials;  Psychology / Psychiatry
Article Date: 03 Sep 2007 - 8:00 PDT

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A new experimental drug for the treatment of schizophrenia which targets glutamate receptors in the brain rather than dopamine has shown promise in human trials. The volunteers experienced significant improvements in their symptoms while suffering few side effects. The drug is currently called "LY2140023".

You can read about this trial in an article published in Nature Medicine. Experts are encouraged by the news and would like to see further trials carried out as soon as possible.

In this randomized, double-blind, placebo-controlled clinical trial, patients received four weeks treatment either with LY2140023, olanzapine, or a placebo. They found that:

-- LY2140023 and olanzapine improved patients' symptoms significantly within one week compared to the placebo. They used the Positive and Negative Syndrome Scale (PANNS) to measure symptoms.

-- The patients taking LY2140023 did not appear to experience any of the side effects commonly associated with modern schizophrenia drugs. There was no weight gain, prolactin levels did not rise and there were no extrapyramidal symptoms (involuntary movements or muscle stiffness).

-- The trial concluded that LY2140023, taken twice daily, appears to be safe and well tolerated. Adverse events were mild-to-moderate and did not limit treatment.

Steven Paul, M.D., Lilly's executive vice president of science and technology, said "These data provide compelling new evidence that mGlu2/3 receptor agonists have antipsychotic properties and may provide a completely new therapeutic approach for treating schizophrenia and, perhaps, other neuropsychiatric disorders. Additional and longer-term studies are needed to confirm and extend these exciting initial findings. However, these data suggest that LY2140023 may provide a new alternative for the treatment of this often devastating condition."

Study Design

It was a proof of concept study, the aim being to decide whether LY2140023 was superior to a placebo. Olanzapine was used as an active control. 196 people who suffered from schizophrenia were randomly selected to either receive LY2140023 at 40mg twice daily, olanzapine at 15mg daily or a placebo. All the volunteers remained in hospital before the trial and during it. They were all tapered of their existing medications before the trial began.

About Schizophrenia

Schizophrenia is a severe and debilitating psychosis. It is frequently characterized by acute episodes of false beliefs that cannot be corrected by reason (delusions), hallucinations which generally appear in the form of voices which are not there, diminished emotion over the long term, lack of interest, and signs and symptoms of depression. Approximately 24 million people suffer from schizophrenia globally.

"Activation of mGlu2/3 receptors as a new approach to treat schizophrenia: a randomized Phase 2 clinical trial"
Sandeep T Patil, Lu Zhang, Ferenc Martenyi, Stephen L Lowe, Kimberley A Jackson, Boris V Andreev, Alla S Avedisova, Leonid M Bardenstein, Issak Y Gurovich, Margarita A Morozova, Sergey N Mosolov, Nikolai G Neznanov, Alexander M Reznik, Anatoly B Smulevich, Vladimir A Tochilov, Bryan G Johnson, James A Monn & Darryle D Schoepp
Nature Medicine doi:10.1038/nm1632
Click here to view Letter Abstract online

LY2140023 belongs to Eli Lilly and Company

Written by: Christian Nordqvist
Copyright: Medical News Today
Not to be reproduced without permission of Medical News Today