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Latuda Medical Research Studies

Up-to-date List of Latuda Medical Research Studies

What Research is Being Done?

A clinical study involves research using human volunteers (also called participants) that is intended to add to medical knowledge. There are two main types of clinical studies: clinical trials (also called interventional studies) and observational studies. Following list includes both interventional and observational studies.

Latest Latuda Medical Research Studies

Rank Status Study
1 Not yet recruiting Open-Label Study of Latuda for the Treatment of Mania in Children and Adolescents 6-17 Years Old
Conditions: Mania;   Bipolar I;   Bipolar II;   Bipolar Spectrum Disorder;   Bipolar Disorder
Intervention: Drug: Latuda (Lurasidone)
Outcome Measure: Young Mania Rating Scale
2 Recruiting Pediatric Autism Study
Condition: Autism
Interventions: Drug: Lurasidone 20 mg daily;   Drug: Lurasidone;   Drug: Placebo
Outcome Measures: Change from Baseline to Week 6 in the ABC irritability subscale;   Change from Baseline in Clinical Global Impression severity (CGI-S) scale;   Change in Clinical Global Impression Improvement (CGI-I) scale;   Change from Baseline in other Aberrant Behavior Checklist (ABC) subscale scores (hyperactivity, stereotypy, inappropriate speech, and lethargy/social withdrawal);   Change from Baseline in Children's Yale-Brown Obsessive Compulsive Scales (CY-BOCS) modified for pervasive developmental disorders (PDDs);   Change from Baseline in the Caregiver Strain Questionnaire (CGSQ);   Proportion of subjects who have CGI-I score of 1 (very much improved) or 2 (much improved) at Week 6;   Proportion of subjects who have at least 25% reduction from Baseline to Week 6 in the ABC irritability subscale score.;   Number of Participants with Adverse Event Reporting;   Laboratory Tests - actual values and change from Baseline values for each time point measured.;   Vital Signs - actual values and change from Baseline values for each time point measured.;   Body Weight-Body Mass Index;   Waist Circumference;   Physical Examination - assessment of general appearance and a review of systems;   Height (as measured by stadiometer);   Electrocardiogram;   Barnes Akathisia Rating Scale (BARS);   Abnormal Involuntary Movement Scale (AIMS);   Simpson-Angus Scale (SAS);   Tanner Staging;   Menstrual Cyclicity - Menstrual cyclicity will be monitored in female subjects who have begun menses. At Baseline, female subjects will be given a calendar to mark the beginning and end of each menses.
3 Recruiting Pediatric Schizophrenia Efficacy and Safety Study
Condition: Schizophrenia
Interventions: Drug: Lurasidone 40 mg;   Drug: Lurasidone 80 mg;   Drug: Placebo 40 or 80 mg
Outcome Measures: The primary efficacy variable is change from Baseline in the Positive and Negative Syndrome Scale (PANSS) total score at Week 6.;   Change from Baseline in Clinical Global Impression severity (CGI-S) scale at Day 4, Weeks 1, 2, 3, 4, 5, and 6;   Change from Baseline in PANSS total score at Day 4, Weeks 1, 2, 3, 4, and 5;   Change from Baseline in PANSS positive, negative, general psychopathology, and excitability subscale scores at Day 4, Weeks 1, 2, 3, 4, 5, and 6;   Proportion of responders, where response is based on ≥ 20% improvement from Baseline in PANSS total score at Week 6;   Change from Baseline in Pediatric Quality of Life Enjoyment and Satisfaction Questionnaire (PQ-LES-Q) at Week 6;   Change from Baseline in Clinician-rated Children's Global Assessment Scale (CGAS) at Week 6;   Adverse Events;   Vital signs - will consist of supine systolic and diastolic blood pressures, respiration rate, heart rate, and oral body temperature;   Weight and Waist circumference;   CogState Computerized Cognitive Test Battery;   Barnes Akathisia Rating Scale (BARS);   Abnormal Involuntary Movement Scale (AIMS);   Simpson-Angus Scale (SAS);   Columbia Suicide Severity Rating Scale (C-SSRS);   Tanner Staging;   Menstrual Cyclicity - At Baseline, female subjects will be given a calendar to mark the beginning and end of each menses. History of menstrual cyclicity and irregularities will be collected at Visit 1.;   Proportion of remitters, defined as subjects who have score not exceeding 3(mild severity) for items P1, P3, N1, N4, N6, G5 and G9 of the PANSS at Week 6.
4 Recruiting High Dose Lurasidone for Patients With Treatment Resistant Schizophrenia
Condition: Schizophrenia
Intervention: Drug: Lurasidone
Outcome Measure: Change in positive symptoms of schizophrenia
5 Recruiting Lurasidone and Cognition in Bipolar I Disorder
Condition: Bipolar I Disorder
Intervention: Drug: Lurasidone
Outcome Measure: Cognitive Change in Bipolar I disorder after treatment with Lurasidone
6 Recruiting Pediatric Open-Label Extension Study
Conditions: Schizophrenia;   Autism;   Bipolar Depression
Intervention: Drug: Lurasidone 20, 40, 60, 80 mg, flexibly dosed
Outcome Measures: Number of treatment-emergent adverse events (TEAEs), TEAEs leading to discontinuation and serious AEs (SAEs);   Change in Laboratory tests;   Change in Movement disorders as assessed by Abnormal Involuntary Movement Scale (AIMS), Barnes Akathisia Rating Scale (BARS), and the Simpson-Angus Scale (SAS);   Change in Tanner staging, and menstrual cyclicity (female subjects);   Change in Vital Signs;   Change in Body weight and body mass index;   Change in Physical Examination;   Change in height (as measured by stadiometer);   Change in electrocardiogram;   Columbia Suicide Severity Rating Scale (C-SSRS);   CogState Computerized Cognitive Test Battery;   Udvalg for Kliniske Undersogelser Side Effect Rating Scale (UKU);   Clinical Global Impression-Severity (CGI-S) scale;   Positive and Negative Syndrome Scale (PANSS);   Clinician-rated Children's Global Assessment Scale (CGAS);   Pediatric Quality of Life Enjoyment and Satisfaction Questionnaire (PQ-LES-Q);   Aberrant Behavior Checklist (ABC);   Children's Yale-Brown Obsessive Compulsive Scales;   Caregiver Strain Questionnaire (CGSQ);   Children's Depression Rating Scale, Revised (CDRS-R);   Young Mania Rating Scale (YMRS);   Clinical Global Impression-Bipolar Version, Severity of Illness (CGI-BP-S);   Pediatric Anxiety Rating Scale (PARS);   Attention Deficit/Hyperactivity Disorder Rating Scale (ADHD-RS)
7 Recruiting Lurasidone Pediatric Bipolar Study
Condition: Bipolar I Depression
Interventions: Drug: Lurasidone;   Drug: Placebo
Outcome Measures: Change in the Children's Depression Rating Scale, Revised (CDRS-R) total score as compared to placebo from Double-Blind Baseline to Week 6 (Day 43);   Change from Baseline in Pediatric Anxiety Rating Scale (PARS) score as compared to placebo.;   Change from Baseline in Pediatric Quality of Life Enjoyment and Satisfaction Questionnaire (PQ-LES-Q) score as compared to placebo.;   Change from Baseline in Clinician-rated Children's Global Assessment Scale (CGAS) score as compared to placebo.;   Proportion of responders, where response is defined as ≥ 50% reduction from Baseline in adjusted CDRS-R total score at last observation carried forward (LOCF) Endpoint as compared to placebo.;   Proportion of subjects achieving remission, where remission is defined as post-baseline CDRS-R Total Score ≤ 28 and Young Mania Rating Scale (YMRS) total score ≤ 8 and Clinical Global Impressions-Bipolar Version Severity (CGI-BP-S) depression score ≤ 3.;   Change from Baseline in Attention-Deficit/Hyperactivity Disorder Rating Scale (ADHD-RS) score as compared to placebo.;   Proportions of subjects with adverse events (AEs), discontinuations due to AEs, and serious AEs (SAEs);   Frequency and severity of suicidality using the Columbia Suicide Severity Rating Scale (C-SSRS);   Vital signs and ECG measurements;   Movement disorders assessed by the Barnes Akathisia Rating Scale (BARS), the Abnormal Involuntary Movement Scale (AIMS), and the Simpson-Angus Scale (SAS);   Weight, body mass index (BMI), and waist circumference;   Laboratory measures (including hormonal parameters), Tanner staging, menstrual cyclicity (female subjects), and physical examinations;   CogState Computerized Cognitive Test Battery;   Udvalg for Kliniske Undersogelser Side Effect Rating Scale (UKU);   Proportion of subjects with treatment-emergent mania, defined as a YMRS score of ≥ 20 on any 2 consecutive visits or at the final assessment, or an AE of mania or hypomania.
8 Recruiting A Phase III Study of SM-13496 (Lurasidone HCl) in Patients With Schizophrenia
Condition: Schizophrenia
Interventions: Drug: SM-13496 40mg;   Drug: SM-13496 80mg;   Drug: Placebo
Outcome Measure: Change from baseline in PANSS total score
9 Recruiting This is an Open-label, Multi-center, Extension Study Designed to Evaluate the Longer Term Safety, Tolerability and Effectiveness of Lurasidone, Flexibly Dosed, Adjunctive to Lithium or Divalproex for the Treatment of Subjects With Bipolar I Disorder Who Have Participated in Study D1050296
Condition: Bipolar I Disorder
Intervention: Drug: Lurasidone
Outcome Measures: Treatment-emergent adverse events and treatment-emergent adverse events leading to discontinuation and serious adverse events;   Physical examination - general appearance, head, eyes, ears/nose/throat, neck, lymph nodes, skin, lungs, heart, abdomen, musculoskeletal, and neurologic evaluations.;   Weight - Body Mass Index (BMI) will be calculated in kg/m2.;   Columbia Suicide Severity Rating Scale C-SSRS;   Movement disorders assessed by Abnormal Involuntary Movement Scale (AIMS);   Young Mania Rating Scale (YMRS) total score Montgomery-Asberg Depression Rating Scale (MADRS) total score;   Quick Inventory of Depressive Symptomatology - Self Report (QIDS SR16) total score;   Positive and Negative Syndrome Scale Positive Subscale (PANSS P) score;   Clinical Global Impression Bipolar Version, Severity of Illness (CGI-BP-S) score (overall, depression, mania) Sheehan Disability Scale (SDS) total score and SDS subscales;   Quality of Life Enjoyment and Satisfaction Questionnaire-Short Form (Q-LES-Q-SF);   Pittsburgh Insomnia Rating Scale (PIRS-2);   Health Services Utilization Questionnaire (HSUQ) (US sites only);   SF-12 Health Survey;   Medication Satisfaction Questionnaire (MSQ);   Intend to attend assessment;   Laboratory measures;   Vital Signs;   Electrocardiogram;   Movement disorders assessed by Barnes Akathisia Rating Scale (BARS);   Movement disorders as assessed by Simpson-Angus Scale (SAS);   Mania as assessed by Young Mania Rating Scale (YMRS);   Depression as assessed by Montgomery-Asberg Depression Rating Scale (MADRS);   Severity of illness as assessed by the Clinical Global Impression Bipolar Version, Severity of Illness (CGI-BP-S);   Functionality as assessed by Sheehan Disability Scale (SDS)
10 Recruiting A Phase III Study of SM-13496 in Patients With Bipolar I Depression.
Condition: Bipolar Depression
Intervention: Drug: SM-13496 (lurasidone HCl)
Outcome Measures: Change from baseline in Montgomery-Asberg Depression Rating Scale (MADRS) total score;   Change from baseline in the CGI-BP-S (depression) score.;   Change from baseline in the SDS total score;   Change from baseline in the YMRS total score;   Change from baseline in the HAM-A total score;   Incidence of Adverse events (AEs) and Adverse drug reactions (ADRs)
11 Recruiting Major Depressive Disorder (MDD) With Mixed Features - Flexible Dose
Condition: Major Depressive Disorder With Mixed Features
Interventions: Drug: Lurasidone;   Drug: Placebo
Outcome Measures: Mean Change from baseline to the 6-week study endpoint in Montgomery-Asberg Depression Rating Scale (MADRS) total scores;   Mean change from baseline to the 6-week study endpoint in the Clinical Global Impression-Severity of Illness (CGI-S) score;   Mean change from baseline to endpoint in the Young Mania Rating Scale (YMRS) score;   Mean change from baseline to endpoint in the Sheehan Disability Scale (SDS) total score the SDS subscale scores;   Mean change in baseline to endpoint in the Hamilton Rating Scale for Anxiety(HAM-A) total score;   Proportion of subjects who achieve a response, defined as ≥ 50% reduction from baseline on the Montgomery-Asberg Depression Rating Scale (MADRS) total score at endpoint;   Proportion of subjects who achieve a remission, defined as a Montgomery-Asberg Depression Rating Scale (MADRS) total score of ≤ 12 at endpoint;   Proportion of subjects with treatment-emergent mania, assessed by a Young Mania Rating Scale (YMRS) total score of ≥ 16 on any two consecutive visits or at the final assessment, or an AE of mania or hypomania;   • Proportion of subjects with AEs and SAEs, and discontinuations due to AEs and SAEs;   Vital signs and ECG measurements;   Movement disorders assessed by the Abnormal Involuntary Movement Scale (AIMS), Barnes Akathisia Rating Scale (BARS), and Simpson-Angus Rating Scale (SARS);   Weight and laboratory measures;   Mean change from baseline to endpoint in sexual functioning based on Changes in Sexual Functioning Questionnaire (CSFQ) total score and CSFQ subscale scores;   Frequency and severity of suicidality using Columbia Suicide Severity Rating Scale (C-SSRS)
12 Recruiting Bipolar Maintenance Study of Lurasidone Adjunctive to Lithium or Divalproex
Condition: Bipolar I Disorder
Interventions: Drug: Lurasidone;   Drug: Placebo
Outcome Measures: Time to recurrence of mood event during the double blind treatment phase;   Time to all-cause discontinuation;   Time to recurrence of a manic, mixed manic, hypomanic, or depressed episode;   Proportion of subjects who experience a recurrence of a manic, mixed manic, hypomanic, or depressed episode;   Change from double-blind phase baseline to endpoint in global severity (CGI-B, severity of Illness score) YMRS, MADRS, QIDS - SR16 total score and PANSS-P;   Subject self-report of functional impairment associated with symptoms of bipolar disorder, assessed by the Sheehan Disability Scale (SDS) total score and SDS subscales;   Quality of life assessed by Quality of Life Enjoyment and Satisfaction Questionaire-Short Form (Q-LES-Q-SF);   Sleep Quality assessed by the Pittsburgh Insomnia Rating Scale (PIRS-2);   Health outcome measures: Health Services Utilization Questionaire (HSUQ) and the SF-12 Health Survey;   Medication Satisfaction Questionaire (MSQ);   Proportion of subjects with adverse events (AEs), discontinuation due to AEs, and serious AEs (SAEs);   Columbia Suicide Severity Rating Scale (C-SSRS, physical examination results;   Weight, laboratory measures, vital signs, and electrocardiograms (ECGs);   Movement disorders, as assessed by Abnormal Involuntary Movement Scale(AIMS), Barnes Akathisia Rating Scale (BARS), and the Simpson-Angus Scale (SAS);   Physical Examination
13 Recruiting A Long-Term Study of SM-13496 in Patients With Bipolar I Disorder.
Condition: Bipolar I Disorder
Intervention: Drug: SM-13496 (lurasidone HCl)
Outcome Measures: Incidence of adverse events (AEs) and adverse drug reactions (ADRs);   Change from baseline in the Montgomery-Asberg Depression Rating Scale (MADRS) score;   Change from baseline in the Young Mania Rating Scale (YMRS) total score.;   The time to recurrence/relapse of any mood event from clinical stability of bipolar disorder.
14 Recruiting Long-term Extension Study of SM-13496 (Lurasidone HCl) in Patients With Schizophrenia
Condition: Schizophrenia
Intervention: Drug: SM-13496
Outcome Measure: Change from baseline in PANSS total score
15 Recruiting A Clinical Trial of Lurasidone in Treatment of Schizophrenia
Condition: Schizophrenia
Interventions: Drug: Lurasidone tablets;   Drug: Risperidone tablets
Outcome Measures: Mean change from baseline to Week 6 in PANSS total scores;   Mean change from baseline to Week 6 in CGI-S score;   Proportion of responders (defined as 20% or greater improvement in PANSS total score from baseline at Week 6);   Mean change from baseline to Week 6 in PANSS positive subscale;   Mean change from baseline to Week 6 in PANSS negative subscale;   Mean change from baseline to Week 6 in PANSS general psychopathology subscale;   Mean change from baseline to Week 6 in CDSS scores;   Mean CGI-I score at Week 6
16 Recruiting Efficacy of Cognitive Remediation in Patients With Schizophrenia or Schizoaffective Disorder Stabilized on Lurasidone
Condition: Schizophrenia
Intervention: Drug: Cognitive Remediation
Outcome Measures: Cognitive Function/Assessment;   Functional Levels

These studies may lead to new treatments and are adding insight into Latuda etiology and treatment.

A major focus of Latuda research is the development of new drugs and other treatment options. Studies seek to identify new drugs to treat various related disorders and to find safer, more effective doses for medications already being used. Other research is aimed at identifying receptors or drug targets.


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