Efficacy of Lu AF35700 in Patients With Early-in-disease or Late-in-disease Treatment-resistant Schizophrenia (Anew)
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|ClinicalTrials.gov Identifier: NCT03230864|
Recruitment Status : Recruiting
First Posted : July 27, 2017
Last Update Posted : October 12, 2018
|Condition or disease||Intervention/treatment||Phase|
|Treatment-resistant Schizophrenia||Drug: Lu AF35700 Drug: Risperidone Drug: Olanzapine||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||817 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||Interventional, Randomized, Double-blind, Active-controlled Study of the Efficacy of Lu AF35700 in Patients With Early-in-disease or Late-in-disease Treatment-resistant Schizophrenia|
|Actual Study Start Date :||July 20, 2017|
|Estimated Primary Completion Date :||September 2020|
|Estimated Study Completion Date :||September 2020|
Experimental: Lu AF35700 10 mg
10 mg encapsulated tablets administered orally, once daily.
Drug: Lu AF35700
10 mg/day, encapsulated tablets, orally
Experimental: Continued treatment
4-6 mg risperidone or 15-20 mg olanzapine encapsulated tablets administered orally, once daily.
4-6 mg/day, encapsulated tablets, orally
15-20 mg/day, encapsulated tablets, orally
- Change in Positive and Negative Syndrome Scale (PANSS) total score [ Time Frame: Baseline 2 to Week 14 ]The Positive and Negative Syndrome Scale (PANSS) is a 30-item scale for assessing the symptoms of schizophrenia. For each PANSS item, symptom severity was rated on a 7-point scale, from 1=absent to 7=extreme. The PANSS total score (30 items) ranged from 30 to 210 with a higher score indicating greater severity of symptoms.
- Change in Global Clinical Impression - Severity of Illness (CGI-S) score [ Time Frame: Baseline 2 to Week 14 ]The Clinical Global Impression - Severity of Illness (CGI-S) provides the clinician's impression of the patient's current state of mental illness. The clinician uses his or her clinical experience of this patient population to rate the severity of the patient's current mental illness on a 7-point scale ranging from 1 (normal - not at all ill) to 7 (among the most extremely ill patients).
- Change in 16-item Negative Symptom Assessment (NSA-16 total) score [ Time Frame: Baseline 2 to Week 14 ]The NSA-16 is a clinician-rated scale designed to assess the presence, severity, and range of negative symptoms associated with schizophrenia. The NSA-16 consists of 16 items arranged in 5 subdomains: communication dysfunction (items 1 to 4), emotional/affective dysfunction (items 5 to 7), dysfunction in sociality (items 8 to 10), motivational/hedonic dysfunction (items 11 to 14), and reduced psychomotor activity (items 15 and 16), and a Global Negative Symptom Rating. NSA-16 items are rated on a 6-point scale from 1 (behaviour is normal) to 6 (behaviour severely reduced), and a score of 9 if the item is not-rateable. The Global Negative Symptom Rating is rated from 1 (no evidence of symptoms) to 7 (extremely severe symptoms). The 16 items are summed to yield a total score ranging from 16 to 96 and the global rating ranges from 1 to 7.
- Change in PANSS Negative Factor Score (Marder Negative Score) [ Time Frame: Baseline 2 to Week 14 ]The PANSS Negative Factor score is a subset of the PANSS assessing negative symptoms of schizophrenia. The factor consist of the seven items: blunted affect, emotional withdrawal, poor rapport, passive social withdrawal, lack of spontaneity, motor retardation, and active social avoidance which are each rated on a 7-point scale, from 1=absent to 7=extreme. The PANSS Negative Factor score (7 items) range from 7 to 49 with a higher score indicating greater severity of symptoms.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03230864
|Contact: Email contact via H.Lundbeck A/S||+4536301311||LundbeckClinicalTrials@Lundbeck.com|
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|Study Director:||Email contact via H.Lundbeck A/S||LundbeckClinicalTrials@Lundbeck.com|