Schizophrenia
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CLINICAL_TRIALS trial_result · 2014-06-06Clinical Trial Update: Aripiprazole Treatment of Prodromal Patients [Phase 2, Phase 3]
This document summarizes completed Phase 2/Phase 3 clinical trials evaluating aripiprazole for prodromal symptoms in schizophrenia and relat…
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FDA approval · 2014-06-05FDA Approved: RISPERDAL CONSTA — Supplemental Application (Janssen Pharmaceuticals, Inc.)
FDA approved Janssen's supplemental application for RISPERDAL CONSTA, a long-acting injectable antipsychotic (paliperidone palmitate).
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CLINICAL_TRIALS withdrawal · 2014-06-04Clinical Trial Update: Sarcosine Preventive Therapy for Individuals At High Risk for Schizophrenia [Phase 2]
Phase 2 trial of sarcosine as preventive therapy for individuals at high risk for schizophrenia has been withdrawn.
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CLINICAL_TRIALS trial_result · 2014-06-03Clinical Trial Update: Paliperidone Extended Release(ER) Effectiveness Study to Evaluate the Objective Symptom Change and Symptomatic Remission [Phase 4]
Phase 4 trial evaluating the effectiveness of Paliperidone Extended Release in schizophrenia with results posted in 2014.
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FDA approval · 2014-05-30FDA Approved: ABILIFY MAINTENA — Supplemental Application (Otsuka America Pharmaceutical, Inc.)
The FDA approved a supplemental application for ABILIFY MAINTENA (aripiprazole long-acting injectable) submitted by Otsuka America Pharmaceu…
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CLINICAL_TRIALS trial_result · 2014-05-30Clinical Trial Update: Investigation of the Safety, Tolerability and Potential Therapeutic Effects of JNJ-40411813 in Patients With Schizophrenia [Phase 2]
Phase 2 trial of JNJ-40411813 in schizophrenia has completed, examining safety, tolerability and potential therapeutic effects.
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CLINICAL_TRIALS trial_result · 2014-05-29Clinical Trial Update: Adjunctive SPD489 to Antipsychotic Medication in Clinically Stable Adults With Persistent Predominant Negative Symptoms of Schizophrenia [Phase 3]
Phase 3 trial of adjunctive SPD489 to antipsychotic therapy in adults with persistent prominent negative symptoms of schizophrenia was termi…
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CLINICAL_TRIALS trial_result · 2014-05-29Clinical Trial Update: SPD489 Low Dose and High Dose Ranges When Added to Stable Doses of Antipsychotic Medications in Clinically Stable Adults With Negative Symptoms of Schizophrenia [Phase 3]
Phase 3 trial evaluating SPD489 at low and high doses added to stable antipsychotic regimens in adults with negative symptoms of schizophren…
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CLINICAL_TRIALS trial_result · 2014-05-29Clinical Trial Update: Long-term Safety of SPD489 When Added to Stable Doses of Antipsychotic Medications in Clinically Stable Adults With Negative Symptoms of Schizophrenia [Phase 3]
Phase 3 trial updating long-term safety of SPD489 added to stable antipsychotics in adults with schizophrenia and negative symptoms; study t…
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CLINICAL_TRIALS trial_result · 2014-05-28Clinical Trial Update: Efficacy Study Exploring the Effects on Cognition of Sertindole Versus Comparator in Patients With Schizophrenia [Phase 3]
A Phase 3 efficacy trial comparing sertindole to a comparator in people with schizophrenia to assess cognitive effects has been completed.
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CLINICAL_TRIALS trial_result · 2014-05-28Clinical Trial Update: A Safety and Pharmacokinetic Study of Paliperidone Palmitate in Patients With Schizophrenia [Phase 1]
A Phase 1 safety and pharmacokinetic study evaluated paliperidone palmitate in patients with schizophrenia, describing its PK profile and to…
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CLINICAL_TRIALS trial_result · 2014-05-26Clinical Trial Update: Once-Daily Asenapine for Schizophrenia [Phase 4]
A Phase 4 clinical trial update on once-daily asenapine for schizophrenia, with the study completed and results posted.
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CLINICAL_TRIALS trial_result · 2014-05-23Clinical Trial Update: Medical Chart Review of Patients on Long-term Treatment With Long-acting Injectable Risperidone
A clinical trial update reports on the long-term use of long-acting injectable risperidone in patients with schizophrenia or schizoaffective…
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CLINICAL_TRIALS trial_result · 2014-05-22Clinical Trial Update: Ethyl-EPA Treatment of Prodromal Patients [Phase 2, Phase 3]
Phase 2/3 trial of Ethyl-EPA for prodromal schizophrenia has completed.
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CLINICAL_TRIALS trial_result · 2014-05-22Clinical Trial Update: Shiatsu Adjuvant Therapy For Schizophrenia [NA]
This entry notes the completion of a clinical trial evaluating shiatsu adjuvant therapy for schizophrenia conducted by Herzog Hospital.
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FDA label_change · 2014-05-21FDA Approved: LATUDA — Supplemental Application (Sumitomo Pharma America, Inc.)
The FDA approved a supplemental application for LATUDA (lurasidone hydrochloride) from Sumitomo Pharma America, resulting in changes to the …
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CLINICAL_TRIALS trial_result · 2014-05-21Clinical Trial Update: Characterization of Intramuscular Injections of Risperidone 4 Week Long-acting Injectable (LAI) Formulation in the Buttock of Patients With Schizophrenia [Phase 1]
Phase 1 study characterizing intramuscular four-week long-acting injectable risperidone injections in the buttock of patients with schizophr…
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CLINICAL_TRIALS trial_result · 2014-05-20Clinical Trial Update: The Efficacy and Safety of Quetiapine XR in Patients With Schizophrenia Switched From Other Antipsychotics [Phase 3]
A Phase 3 trial update evaluating the efficacy and safety of quetiapine XR in schizophrenia patients who were switched from other antipsycho…
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FDA approval · 2014-05-15FDA Approved: OLANZAPINE — Original Application (Aurobindo Pharma Limited)
FDA approved the original application for a generic olanzapine manufactured by Aurobindo Pharma Limited.
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CLINICAL_TRIALS trial_result · 2014-05-14Clinical Trial Update: Efficacy and Safety of A-prexa Compared to Zyprexa in Patients With Schizophrenia [Phase 4]
A Phase 4 trial evaluated the efficacy and safety of A-prexa compared with Zyprexa (olanzapine) in patients with schizophrenia-spectrum diso…
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CLINICAL_TRIALS trial_result · 2014-05-08Clinical Trial Update: A Follow-Up Study of Schizophrenic Participants Following Treatment Discontinuation After Remission From a First Psychotic Episode [Phase 4]
Phase 4 follow-up study in schizophrenia patients who achieved remission after a first psychotic episode, evaluating outcomes after disconti…
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CLINICAL_TRIALS trial_result · 2014-05-07Clinical Trial Update: Individually Based Psychosocial Rehabilitation for Older People With Serious Mental Illness (SMI) [Phase 1]
Phase 1 completion of a trial evaluating individually based psychosocial rehabilitation for older adults with serious mental illness, includ…
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CLINICAL_TRIALS research · 2014-05-05Clinical Trial Update: Intensive Transcranial Magnetic Stimulation for Negative Symptoms in Schizophrenia [NA]
The trial investigates intensive transcranial magnetic stimulation for negative symptoms in schizophrenia; the current status is unknown.
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CLINICAL_TRIALS trial_result · 2014-05-02Clinical Trial Update: Does Acute Oxytocin Administration Enhance Social Cognition in Individuals With Schizophrenia? [NA]
A completed clinical trial investigated whether single-dose oxytocin administration improves social cognition in individuals with schizophre…
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FDA approval · 2014-04-29FDA Approved: INVEGA SUSTENNA — Supplemental Application (Janssen Pharmaceuticals, Inc.)
The FDA approved a supplemental application for INVEGA SUSTENNA (paliperidone palmitate) by Janssen Pharmaceuticals, expanding regulatory ap…