Activation of mGlu2/3 receptors as a new approach to treat schizophrenia: a randomized Phase 2 clinical trial
Schizophrenia is a chronic, complex and heterogeneous mental disorder, with pathological features of disrupted neuronal excitability and plasticity within limbic structures of the brain. These pathological features manifest behaviorally as positive symptoms (including hallucinations, delusions and t...
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| Published in | Nature medicine Vol. 13; no. 9; pp. 1102 - 1107 |
|---|---|
| Main Authors | , , , , , , , , , , , , , , , , , |
| Format | Journal Article |
| Language | English |
| Published |
New York
Nature Publishing Group US
01.09.2007
Nature Publishing Group |
| Subjects | |
| Online Access | Get full text |
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| Abstract | Schizophrenia is a chronic, complex and heterogeneous mental disorder, with pathological features of disrupted neuronal excitability and plasticity within limbic structures of the brain. These pathological features manifest behaviorally as positive symptoms (including hallucinations, delusions and thought disorder), negative symptoms (such as social withdrawal, apathy and emotional blunting) and other psychopathological symptoms (such as psychomotor retardation, lack of insight, poor attention and impulse control)
1
. Altered glutamate neurotransmission has for decades been linked to schizophrenia, but all commonly prescribed antipsychotics act on dopamine receptors
2
. LY404039 is a selective agonist for metabotropic glutamate 2/3 (mGlu2/3) receptors
3
and has shown antipsychotic potential in animal studies. With data from rodents, we provide new evidence that mGlu2/3 receptor agonists work by a distinct mechanism different from that of olanzapine. To clinically test this mechanism, an oral prodrug of LY404039 (LY2140023) was evaluated in schizophrenic patients with olanzapine as an active control in a randomized, three-armed, double-blind, placebo-controlled study. Treatment with LY2140023, like treatment with olanzapine, was safe and well-tolerated; treated patients showed statistically significant improvements in both positive and negative symptoms of schizophrenia compared to placebo (
P
< 0.001 at week 4). Notably, patients treated with LY2140023 did not differ from placebo-treated patients with respect to prolactin elevation, extrapyramidal symptoms or weight gain. These data suggest that mGlu2/3 receptor agonists have antipsychotic properties and may provide a new alternative for the treatment of schizophrenia. |
|---|---|
| AbstractList | Schizophrenia is a chronic, complex and heterogeneous mental disorder, with pathological features of disrupted neuronal excitability and plasticity within limbic structures of the brain. These pathological features manifest behaviorally as positive symptoms (including hallucinations, delusions and thought disorder), negative symptoms (such as social withdrawal, apathy and emotional blunting) and other psychopathological symptoms (such as psychomotor retardation, lack of insight, poor attention and impulse control). Altered glutamate neurotransmission has for decades been linked to schizophrenia, but all commonly prescribed antipsychotics act on dopamine receptors. LY404039 is a selective agonist for metabotropic glutamate 2/3 (mGlu2/3) receptors and has shown antipsychotic potential in animal studies. With data from rodents, we provide new evidence that mGlu2/3 receptor agonists work by a distinct mechanism different from that of olanzapine. To clinically test this mechanism, an oral prodrug of LY404039 (LY2140023) was evaluated in schizophrenic patients with olanzapine as an active control in a randomized, three-armed, double-blind, placebo-controlled study. Treatment with LY2140023, like treatment with olanzapine, was safe and well-tolerated; treated patients showed statistically significant improvements in both positive and negative symptoms of schizophrenia compared to placebo (P < 0.001 at week 4). Notably, patients treated with LY2140023 did not differ from placebo-treated patients with respect to prolactin elevation, extrapyramidal symptoms or weight gain. These data suggest that mGlu2/3 receptor agonists have antipsychotic properties and may provide a new alternative for the treatment of schizophrenia.Schizophrenia is a chronic, complex and heterogeneous mental disorder, with pathological features of disrupted neuronal excitability and plasticity within limbic structures of the brain. These pathological features manifest behaviorally as positive symptoms (including hallucinations, delusions and thought disorder), negative symptoms (such as social withdrawal, apathy and emotional blunting) and other psychopathological symptoms (such as psychomotor retardation, lack of insight, poor attention and impulse control). Altered glutamate neurotransmission has for decades been linked to schizophrenia, but all commonly prescribed antipsychotics act on dopamine receptors. LY404039 is a selective agonist for metabotropic glutamate 2/3 (mGlu2/3) receptors and has shown antipsychotic potential in animal studies. With data from rodents, we provide new evidence that mGlu2/3 receptor agonists work by a distinct mechanism different from that of olanzapine. To clinically test this mechanism, an oral prodrug of LY404039 (LY2140023) was evaluated in schizophrenic patients with olanzapine as an active control in a randomized, three-armed, double-blind, placebo-controlled study. Treatment with LY2140023, like treatment with olanzapine, was safe and well-tolerated; treated patients showed statistically significant improvements in both positive and negative symptoms of schizophrenia compared to placebo (P < 0.001 at week 4). Notably, patients treated with LY2140023 did not differ from placebo-treated patients with respect to prolactin elevation, extrapyramidal symptoms or weight gain. These data suggest that mGlu2/3 receptor agonists have antipsychotic properties and may provide a new alternative for the treatment of schizophrenia. Schizophrenia is a chronic, complex and heterogeneous mental disorder, with pathological features of disrupted neuronal excitability and plasticity within limbic structures of the brain. These pathological features manifest behaviorally as positive symptoms (including hallucinations, delusions and thought disorder), negative symptoms (such as social withdrawal, apathy and emotional blunting) and other psychopathological symptoms (such as psychomotor retardation, lack of insight, poor attention and impulse control). Altered glutamate neurotransmission has for decades been linked to schizophrenia, but all commonly prescribed antipsychotics act on dopamine receptors. LY404039 is a selective agonist for metabotropic glutamate 2/3 (mGlu2/3) receptors and has shown antipsychotic potential in animal studies. With data from rodents, we provide new evidence that mGlu2/3 receptor agonists work by a distinct mechanism different from that of olanzapine. To clinically test this mechanism, an oral prodrug of LY404039 (LY2140023) was evaluated in schizophrenic patients with olanzapine as an active control in a randomized, three-armed, double-blind, placebo-controlled study. Treatment with LY2140023, like treatment with olanzapine, was safe and well-tolerated; treated patients showed statistically significant improvements in both positive and negative symptoms of schizophrenia compared to placebo (P < 0.001 at week 4). Notably, patients treated with LY2140023 did not differ from placebo-treated patients with respect to prolactin elevation, extrapyramidal symptoms or weight gain. These data suggest that mGlu2/3 receptor agonists have antipsychotic properties and may provide a new alternative for the treatment of schizophrenia. Schizophrenia is a chronic, complex and heterogeneous mental disorder, with pathological features of disrupted neuronal excitability and plasticity within limbic structures of the brain. These pathological features manifest behaviorally as positive symptoms (including hallucinations, delusions and thought disorder), negative symptoms (such as social withdrawal, apathy and emotional blunting) and other psychopathological symptoms (such as psychomotor retardation, lack of insight, poor attention and impulse control) super(1). Altered glutamate neurotransmission has for decades been linked to schizophrenia, but all commonly prescribed antipsychotics act on dopamine receptors super(2). LY404039 is a selective agonist for metabotropic glutamate 2/3 (mGlu2/3) receptors super(3) and has shown antipsychotic potential in animal studies. With data from rodents, we provide new evidence that mGlu2/3 receptor agonists work by a distinct mechanism different from that of olanzapine. To clinically test this mechanism, an oral prodrug of LY404039 (LY2140023) was evaluated in schizophrenic patients with olanzapine as an active control in a randomized, three-armed, double-blind, placebo-controlled study. Treatment with LY2140023, like treatment with olanzapine, was safe and well-tolerated; treated patients showed statistically significant improvements in both positive and negative symptoms of schizophrenia compared to placebo (P < 0.001 at week 4). Notably, patients treated with LY2140023 did not differ from placebo-treated patients with respect to prolactin elevation, extrapyramidal symptoms or weight gain. These data suggest that mGlu2/3 receptor agonists have antipsychotic properties and may provide a new alternative for the treatment of schizophrenia. Schizophrenia is a chronic, complex and heterogeneous mental disorder, with pathological features of disrupted neuronal excitability and plasticity within limbic structures of the brain. These pathological features manifest behaviorally as positive symptoms (including hallucinations, delusions and thought disorder), negative symptoms (such as social withdrawal, apathy and emotional blunting) and other psychopathological symptoms (such as psychomotor retardation, lack of insight, poor attention and impulse control) 1 . Altered glutamate neurotransmission has for decades been linked to schizophrenia, but all commonly prescribed antipsychotics act on dopamine receptors 2 . LY404039 is a selective agonist for metabotropic glutamate 2/3 (mGlu2/3) receptors 3 and has shown antipsychotic potential in animal studies. With data from rodents, we provide new evidence that mGlu2/3 receptor agonists work by a distinct mechanism different from that of olanzapine. To clinically test this mechanism, an oral prodrug of LY404039 (LY2140023) was evaluated in schizophrenic patients with olanzapine as an active control in a randomized, three-armed, double-blind, placebo-controlled study. Treatment with LY2140023, like treatment with olanzapine, was safe and well-tolerated; treated patients showed statistically significant improvements in both positive and negative symptoms of schizophrenia compared to placebo ( P < 0.001 at week 4). Notably, patients treated with LY2140023 did not differ from placebo-treated patients with respect to prolactin elevation, extrapyramidal symptoms or weight gain. These data suggest that mGlu2/3 receptor agonists have antipsychotic properties and may provide a new alternative for the treatment of schizophrenia. |
| Audience | Academic |
| Author | Tochilov, Vladimir A Monn, James A Schoepp, Darryle D Mosolov, Sergey N Smulevich, Anatoly B Andreev, Boris V Gurovich, Issak Y Morozova, Margarita A Patil, Sandeep T Martenyi, Ferenc Lowe, Stephen L Zhang, Lu Bardenstein, Leonid M Neznanov, Nikolai G Avedisova, Alla S Reznik, Alexander M Jackson, Kimberley A Johnson, Bryan G |
| Author_xml | – sequence: 1 givenname: Sandeep T surname: Patil fullname: Patil, Sandeep T organization: Lilly Research Laboratories, Eli Lilly and Company, Present addresses: Takeda Global Research and Development Center, Inc., One Takeda Parkway, Deerfield, Illinois 60015, USA (S.T.P.); Merck and Company, Inc., 351 Sumneytown Pike, UG/4CDS013, North Wales, Pennsylvania 19454, USA (D.D.S.) – sequence: 2 givenname: Lu surname: Zhang fullname: Zhang, Lu organization: Lilly Research Laboratories, Eli Lilly and Company – sequence: 3 givenname: Ferenc surname: Martenyi fullname: Martenyi, Ferenc email: Martenyi_Ferenc@lilly.com organization: Lilly Medical Center, Kolblgasse 8-10 – sequence: 4 givenname: Stephen L surname: Lowe fullname: Lowe, Stephen L organization: Lilly-National University of Singapore Centre for Clinical Pharmacology, Level 6 Clinical Research Centre (MD11) – sequence: 5 givenname: Kimberley A surname: Jackson fullname: Jackson, Kimberley A organization: Lilly-Erl Wood Manor – sequence: 6 givenname: Boris V surname: Andreev fullname: Andreev, Boris V organization: St. Petersburg State University, St. Petersburg and Gatchinskiy Regional Psychiatric Hospital – sequence: 7 givenname: Alla S surname: Avedisova fullname: Avedisova, Alla S organization: Serbsky State Scientific Center of Social and Forensic Psychiatry, 23, Kropotkinskiy per – sequence: 8 givenname: Leonid M surname: Bardenstein fullname: Bardenstein, Leonid M organization: Moscow State University of Medicine and Dentistry based at Moscow Psychiatry Hospital no. 15, Moscvorechie ul. 7 – sequence: 9 givenname: Issak Y surname: Gurovich fullname: Gurovich, Issak Y organization: Moscow Research Institute of Psychiatry, Poteshnaya ul. 3 – sequence: 10 givenname: Margarita A surname: Morozova fullname: Morozova, Margarita A organization: State Institution “Mental Health Scientific Research Center of the Russian Academy of Medical Sciences”, Kashyrskoye sh. 34 – sequence: 11 givenname: Sergey N surname: Mosolov fullname: Mosolov, Sergey N organization: Moscow Research Institute of Psychiatry, Poteshnaya ul. 3 – sequence: 12 givenname: Nikolai G surname: Neznanov fullname: Neznanov, Nikolai G organization: Bekhterev Research Psychoneurological Institute, Bekhtereva ul. 3 – sequence: 13 givenname: Alexander M surname: Reznik fullname: Reznik, Alexander M organization: Moscow Regional Psychiatry Hospital #5, Abramtsevskoye sh. 1a – sequence: 14 givenname: Anatoly B surname: Smulevich fullname: Smulevich, Anatoly B organization: State Institution “Mental Health Scientific Research Center of the Russian Academy of Medical Sciences”, Kashyrskoye sh. 34 – sequence: 15 givenname: Vladimir A surname: Tochilov fullname: Tochilov, Vladimir A organization: Mechnikov State Medical Academy, Naberezhnaya reki Mojki, 126 – sequence: 16 givenname: Bryan G surname: Johnson fullname: Johnson, Bryan G organization: Lilly Research Laboratories, Eli Lilly and Company – sequence: 17 givenname: James A surname: Monn fullname: Monn, James A email: Monn_James_A@lilly.com organization: Lilly Research Laboratories, Eli Lilly and Company – sequence: 18 givenname: Darryle D surname: Schoepp fullname: Schoepp, Darryle D organization: Lilly Research Laboratories, Eli Lilly and Company, Present addresses: Takeda Global Research and Development Center, Inc., One Takeda Parkway, Deerfield, Illinois 60015, USA (S.T.P.); Merck and Company, Inc., 351 Sumneytown Pike, UG/4CDS013, North Wales, Pennsylvania 19454, USA (D.D.S.) |
| BackLink | https://www.ncbi.nlm.nih.gov/pubmed/17767166$$D View this record in MEDLINE/PubMed |
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