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Trial record 1 of 2 for:    LU 16159A
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Effect of Lu AF35700 in Patients With Treatment-resistant Schizophrenia (DayBreak)

This study is currently recruiting participants.
Verified December 2017 by H. Lundbeck A/S
Sponsor:
ClinicalTrials.gov Identifier:
NCT02717195
First Posted: March 23, 2016
Last Update Posted: December 6, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
H. Lundbeck A/S
  Purpose
To evaluate the efficacy of 10 and 20 mg/day of Lu AF35700 on schizophrenia symptoms in patients with treatment-resistant schizophrenia (TRS)

Condition Intervention Phase
Schizophrenia Drug: Risperidone Drug: Olanzapine Drug: Lu AF35700 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Interventional, Randomised, Double-blind, Active-controlled, Fixed-dose Study of Lu AF35700 in Patients With Treatment-resistant Schizophrenia

Resource links provided by NLM:


Further study details as provided by H. Lundbeck A/S:

Primary Outcome Measures:
  • Symptoms of schizophrenia [ Time Frame: From Period B (week 6) to study Week 16 ]
    Change in Positive and Negative Syndrome Scale (PANSS) total score


Secondary Outcome Measures:
  • Global clinical impression [ Time Frame: From Period B (week 6) to study Week 16 ]
    Change in Clinical Global Impression Severity scale (CGI-S)

  • Functioning [ Time Frame: From Period B (week 6) to study Week 16 ]
    Change in Personal and Social Performance (PSP) total score


Estimated Enrollment: 964
Study Start Date: April 2016
Estimated Study Completion Date: January 2019
Estimated Primary Completion Date: January 2019 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Period A
Single (patient)-blinded treatment period with risperidone or olanzapine for 6 weeks
Drug: Risperidone
4-6 mg/day, encapsulated tablets, orally
Drug: Olanzapine
15-20 mg/day, encapsulated tablets, orally
Experimental: Period B, Lu AF35700 10 mg
Eligible patients from Period A (based on criteria to which investigator and patient are blinded), will be randomly assigned (1:1:1) Double-blind treatment in Period B, 10 weeks
Drug: Lu AF35700
10 mg/day, encapsulated tablets, orally
Experimental: Period B, Lu AF35700 20 mg
Eligible patients from Period A (based on criteria to which investigator and patient are blinded), will be randomly assigned (1:1:1) Double-blind treatment in Period B, 10 weeks
Drug: Lu AF35700
20 mg/day, encapsulated tablets, orally
Experimental: Period B, Continued treatment from Period A
Eligible patients from Period A (based on criteria to which investigator and patient are blinded), will be randomly assigned (1:1:1) Double-blind treatment in Period B,10 weeks. Patients in this arm will continue with same the treatment and dose as at last visit of period A
Drug: Risperidone
4-6 mg/day, encapsulated tablets, orally
Drug: Olanzapine
15-20 mg/day, encapsulated tablets, orally

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • The patient has schizophrenia, diagnosed according to DSM-5(TM) (Diagnostic and Statistical Manual of Mental Disorders) and confirmed by the Mini International Neuropsychiatric Interview for Schizophrenia and Psychotic Disorders
  • The patient is either an inpatient at a psychiatric setting or outpatient consulting a psychiatrist.
  • Patients should be treated with adequate dose(s) and agent(s) of antipsychotic treatment for at least 2 weeks prior to Screening
  • The patient has failed to show an adequate response in the level of psychotic symptoms despite at least one documented treatment trial with an adequate dose of an antipsychotic agent prescribed for an adequate time (at least lasting for 6 weeks) during 2 years prior to Screening. The failure to respond to the current antipsychotic treatment trial may be considered a retrospective failed treatment, if the patient was treated for 6 weeks with adequate dose(s) and agent(s)
  • The patient has a PANSS total score of ≥80 and a score of ≥4 on at least 2 of the following PANSS items (at Screening and at the first visit of Period A)
  • The patient has a CGI-S score of ≥4 at Screening and at the first visit of Period A

Exclusion Criteria:

  • The patient has any current primary psychiatric disorder other than schizophrenia as assessed by the Mini International Neuropsychiatric Interview (MINI)
  • The patient is experiencing an acute exacerbation of his/her psychotic symptoms
  • The patient has not responded to treatment with clozapine

Other protocol defined inclusion and exclusion criteria may apply

  Contacts and Locations
Information from the National Library of Medicine

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): NCT02717195


Contacts
Contact: Email contact via H. Lundbeck A/S +4536301311 LundbeckClinicalTrials@Lundbeck.com

  Show 146 Study Locations
Sponsors and Collaborators
H. Lundbeck A/S
Investigators
Study Director: Email contact via H. Lundbeck A/S LundbeckClinicalTrials@Lundbeck.com
  More Information

Responsible Party: H. Lundbeck A/S
ClinicalTrials.gov Identifier: NCT02717195     History of Changes
Other Study ID Numbers: 16159A
2014-003569-12 ( EudraCT Number )
First Submitted: March 11, 2016
First Posted: March 23, 2016
Last Update Posted: December 6, 2017
Last Verified: December 2017

Additional relevant MeSH terms:
Schizophrenia
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders
Risperidone
Olanzapine
Serotonin Antagonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs
Dopamine Antagonists
Dopamine Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Gastrointestinal Agents
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators