Schizophrenia
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CLINICAL_TRIALS trial_result · 2024-04-29Clinical Trial Update: Evaluation of Tolcapone as a Cognitive Enhancer in Schizophrenia [Phase 2]
This document reports on a Phase 2 clinical trial evaluating tolcapone as a cognitive enhancer in schizophrenia.
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CLINICAL_TRIALS research · 2024-04-29Clinical Trial Update: A Phase 1, SAD Study to Evaluate the Safety and Tolerability of LY03017 [Phase 1]
Phase 1 single-ascending-dose study to evaluate the safety and tolerability of LY03017; the trial is not yet recruiting for indications incl…
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CLINICAL_TRIALS trial_result · 2024-04-26Clinical Trial Update: Neural Oscillations as Genetic and Functional Biomarkers in Normal and Disease States
Completed clinical trial investigating neural oscillations as genetic and functional biomarkers across normal and disease states, including …
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CLINICAL_TRIALS research · 2024-04-25Clinical Trial Update: Effect of tDCS on Inflammatory Biomarkers in Chronic Schizophrenia [NA]
A clinical study is investigating whether transcranial direct current stimulation (tDCS) affects inflammatory biomarkers in chronic schizoph…
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CLINICAL_TRIALS trial_result · 2024-04-22Clinical Trial Update: Raloxifene as an Adjuvant Treatment of the Negative Symptoms of Schizophrenia in Post-menopausal Women [Phase 3]
Phase 3 clinical trial evaluating raloxifene as an adjuvant treatment for negative symptoms in post-menopausal women with schizophrenia has …
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CLINICAL_TRIALS trial_result · 2024-04-19Clinical Trial Update: The Safety and Efficacy of Lurasidone In Subjects With Schizophrenia Switched From Olanzapine [Phase 4]
A Phase 4 clinical trial evaluating the safety and efficacy of lurasidone in schizophrenia patients who were switched from olanzapine has be…
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CLINICAL_TRIALS trial_result · 2024-04-19Clinical Trial Update: Study of Systemic and Ocular Safety and Pharmacokinetics of BI 409306 in Patients With Schizophrenia, Alzheimer's Disease, and Healthy Volunteers [Phase 1]
Phase 1 study assessing systemic and ocular safety and pharmacokinetics of BI 409306 in schizophrenia, Alzheimer's disease, and healthy volu…
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CLINICAL_TRIALS trial_result · 2024-04-18Clinical Trial Update: The Safety and Efficacy of Lurasidone With Different Initiation Dose in Chinese Acute Phase Patients With Schizophrenia [Phase 4]
A Phase 4 trial evaluating safety and efficacy of lurasidone with different initiation doses in Chinese patients with schizophrenia has comp…
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CLINICAL_TRIALS trial_result · 2024-04-15Clinical Trial Update: Neurotransmitters in Treatment Resistant Schizophrenia Patients With add-on Sodium Benzoate [Phase 2]
Phase 2 clinical trial evaluating add-on sodium benzoate for treatment-resistant schizophrenia, focusing on symptom and cognitive outcomes.
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FDA approval · 2024-04-11FDA Approved: HALOPERIDOL — Original Application (Lifestar Pharma LLC)
FDA approved a generic haloperidol product from Lifestar Pharma LLC under an Original Application (ANDA 216918).
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CLINICAL_TRIALS trial_result · 2024-04-10Clinical Trial Update: A Clinical Trial to Evaluate Safety, Tolerance and Pharmacokinetics of JX11502MA Capsule in Patients With Schizophrenia. [Phase 1, Phase 2]
A clinical trial evaluating safety, tolerance, and pharmacokinetics of JX11502MA capsule in schizophrenia has completed Phase 1 and Phase 2.
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CLINICAL_TRIALS trial_result · 2024-04-08Clinical Trial Update: An Open-Label, Single Arm Study of the Efficacy of Accelerated Intermittent Theta Burst Stimulation in Schizophrenia Patients With Persistent Negative Symptoms [Phase 3]
A Phase 3 open-label, single-arm trial assessing accelerated intermittent theta burst stimulation for persistent negative symptoms in schizo…
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FDA approval · 2024-04-02FDA Approved: FANAPT — Supplemental Application (Vanda Pharmaceuticals Inc.)
The FDA approved a supplemental application for FANAPT (iloperidone) submitted by Vanda Pharmaceuticals Inc.
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CLINICAL_TRIALS trial_result · 2024-03-28Clinical Trial Update: Antidepressant Controlled Trial for Negative Symptoms in Schizophrenia [Phase 4]
Phase 4 clinical trial update for an antidepressant targeting negative symptoms in schizophrenia has completed with results posted.
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FDA approval · 2024-03-21FDA Approved: PALIPERIDONE — Supplemental Application (Amneal Pharmaceuticals LLC)
FDA approved Amneal's supplemental application for Paliperidone, enabling the marketing of a generic paliperidone product. This is an admini…
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FDA approval · 2024-03-15FDA Approved: ARIPIPRAZOLE — Supplemental Application (Chartwell RX, LLC)
FDA approved a supplemental application for aripiprazole submitted by Chartwell RX, LLC, indicating regulatory approval of a supplement rela…
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CLINICAL_TRIALS trial_result · 2024-03-15Clinical Trial Update: A Clinical Trial to Evaluate the Efficacy and Safety of SEP-363856 in Acutely Psychotic People With Schizophrenia, Followed by an Open-label Extension Phase [Phase 2, Phase 3]
Clinical trial evaluating SEP-363856 in acutely psychotic schizophrenia patients, with an open-label extension; study terminated.
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FDA approval · 2024-03-15FDA Approved: CHLORPROMAZINE HYDROCHLORIDE — Supplemental Application (Zydus Lifesciences Limited)
FDA approved a supplemental application for chlorpromazine hydrochloride (generic) from Zydus Lifesciences Limited.
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FDA approval · 2024-03-13FDA Approved: CHLORPROMAZINE HYDROCHLORIDE — Original Application (Zydus Pharmaceuticals USA Inc.)
FDA approved an original ANDA for chlorpromazine hydrochloride from Zydus Pharmaceuticals USA Inc., making this generic antipsychotic availa…
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FDA approval · 2024-03-12FDA Approved: OLANZAPINE — Supplemental Application (Aurobindo Pharma Limited)
This FDA document relates to a supplemental application for the generic antipsychotic olanzapine from Aurobindo Pharma Limited. The action p…
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FDA approval · 2024-03-11FDA Approved: QUETIAPINE — Supplemental Application (Solco Healthcare U.S., LLC)
FDA approved a supplemental application for a generic version of quetiapine, enabling Solco Healthcare U.S., LLC to market a generic quetiap…
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EMA approval · 2024-03-08EMA Authorised: Zalasta (olanzapine) — Krka
Krka-licensed olanzapine (Zalasta) has been authorised in the EU for schizophrenia and bipolar disorder.
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CLINICAL_TRIALS trial_result · 2024-03-08Clinical Trial Update: Safety and Tolerability of BI 409306 in Patients With Schizophrenia [Phase 1]
This Phase 1 trial assessed the safety and tolerability of BI 409306 in patients with schizophrenia. Results have been posted following stud…
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FDA approval · 2024-03-05FDA Approved: RISPERIDONE — Supplemental Application (Solco Healthcare US, LLC)
The FDA approved a supplemental application for risperidone filed by Solco Healthcare US, LLC.
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FDA approval · 2024-03-05FDA Approved: RISPERIDONE — Supplemental Application (Chartwell RX, LLC)
FDA approved a supplemental application for risperidone from Chartwell RX, LLC, authorizing the generic product under the approved label.