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Trial record 47 of 64 for:    brexpiprazole

Brexpiprazole in Patients With Acute Schizophrenia

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ClinicalTrials.gov Identifier: NCT01810380
Recruitment Status : Completed
First Posted : March 13, 2013
Results First Posted : March 29, 2016
Last Update Posted : March 16, 2017
Sponsor:
Collaborator:
Otsuka Pharmaceutical Co., Ltd.
Information provided by (Responsible Party):
H. Lundbeck A/S

Brief Summary:
To determine the efficacy and safety of brexpiprazole for the treatment of adults experiencing an acute episode of schizophrenia.

Condition or disease Intervention/treatment Phase
Schizophrenia Drug: Placebo Drug: Brexpiprazole Drug: Quetiapine extended release Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 468 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Interventional, Randomised, Double-blind, Parallel-group, Placebo-controlled, Active-reference, Flexible-dose Study of Brexpiprazole in Patients With Acute Schizophrenia
Study Start Date : March 2013
Actual Primary Completion Date : December 2014
Actual Study Completion Date : December 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Schizophrenia

Arm Intervention/treatment
Placebo Comparator: Placebo Drug: Placebo
Once daily as tablets and capsules, orally

Experimental: Brexpiprazole
Patients randomised to brexpiprazole received 1mg/day on Day 1, 2mg/day on Day 2, 3mg/day on Day 3 (uptitration); the dose could be adjusted from Day 4 onwards to 2, 3, or 4mg/day to optimise the clinical effect and tolerability.
Drug: Brexpiprazole
2-4 mg/day, once daily, tablets, orally

Quetiapine extended release
Active Reference. Patients randomised to quetiapine received 300mg/day on Day 1, 600mg/day on Days 2 and 3 (uptitration); the dose could be adjusted from Day 4 onwards to 400, 600, or 800mg/day to optimise the clinical effect and tolerability.
Drug: Quetiapine extended release
400-800 mg/day, once daily, encapsulated tablets, orally
Other Name: Seroquel XL®/XR®




Primary Outcome Measures :
  1. Change From Baseline to Week 6 in PANSS Total Score [ Time Frame: Baseline and Week 6 ]
    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.


Secondary Outcome Measures :
  1. Change From Baseline to Week 6 in CGI-S Score [ Time Frame: Baseline and Week 6 ]

    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).


  2. CGI-I Score at Week 6 [ Time Frame: Week 6 ]

    The Clinical Global Impression - Global Improvement (CGI-I) provides the clinician's impression of the patient's improvement (or worsening).

    The clinician assesses the patient's condition relative to a baseline on a 7-point scale ranging from 1 (very much improved) to 7 (very much worse). In all cases, the assessment should be made independent of whether the rater believes the improvement is drug-related or not.


  3. Change From Baseline to Week 6 in PANSS Positive Subscale Score [ Time Frame: Baseline and Week 6 ]
    The Positive and Negative Syndrome Scale (PANSS) is a clinician rated scale designed to measure severity of psychopathology in adult patients with schizophrenia, schizoaffective disorders and other psychotic disorders. It emphasizes positive and negative symptoms. The PANSS Positive Subscale score is calculated from 7 items (for example: delusions, conceptual disorganization and hallucinatory behaviour). Symptom severity was rated on a 7-point scale, from 1=absent to 7=extreme. Higher score indicating greater severity of symptoms

  4. Change From Baseline to Week 6 in PANSS Negative Subscale Score [ Time Frame: Baseline and Week 6 ]
    The Positive and Negative Syndrome Scale (PANSS) is a clinician rated scale designed to measure severity of psychopathology in adult patients with schizophrenia, schizoaffective disorders and other psychotic disorders. It emphasizes positive and negative symptoms. The PANSS Negative Subscale score is calculated from 7 items (for example: blunted affect, emotional withdrawal and poor rapport). Symptom severity was rated on a 7-point scale, from 1=absent to 7=extreme. Higher score indicating greater severity of symptoms

  5. Change From Baseline to Week 6 in PANSS General Psychopathology Subscale Score [ Time Frame: Baseline and Week 6 ]
    The Positive and Negative Syndrome Scale (PANSS) is a clinician rated scale designed to measure severity of psychopathology in adult patients with schizophrenia, schizoaffective disorders and other psychotic disorders. It emphasizes positive and negative symptoms. The PANSS General Psychopathology Subscale score is calculated from 16 items (for example: somatic concern, anxiety and guilt feelings). Symptom severity was rated on a 7-point scale, from 1=absent to 7=extreme. Higher score indicating greater severity of symptoms

  6. Change From Baseline to Week 6 in PANSS Excited Component Score [ Time Frame: Baseline and Week 6 ]
    The Positive and Negative Syndrome Scale (PANSS) is a clinician rated scale designed to measure severity of psychopathology in adult patients with schizophrenia, schizoaffective disorders and other psychotic disorders. It emphasizes positive and negative symptoms. The PANSS Excited Component score is calculated from 5 items (for example: poor impulse control, tension and hostility). Symptom severity was rated on a 7-point scale, from 1=absent to 7=extreme. Higher score indicating greater severity of symptoms

  7. Change From Baseline to Week 6 in PANSS Marder Factor Scores: Negative Symptoms [ Time Frame: Baseline and Week 6 ]
    The Positive and Negative Syndrome Scale (PANSS) is a clinician rated scale designed to measure severity of psychopathology in adult patients with schizophrenia, schizoaffective disorders and other psychotic disorders. It emphasizes positive and negative symptoms. The PANSS Marder Factor scores: negative symptoms is calculated from 7 items (for example: blunted affect, emotional withdrawal and motor retardation). Symptom severity was rated on a 7-point scale, from 1=absent to 7=extreme. Higher score indicating greater severity of symptoms

  8. Change From Baseline to Week 6 in PANSS Marder Factor Scores: Positive Symptoms [ Time Frame: Baseline and Week 6 ]
    The Positive and Negative Syndrome Scale (PANSS) is a clinician rated scale designed to measure severity of psychopathology in adult patients with schizophrenia, schizoaffective disorders and other psychotic disorders. It emphasizes positive and negative symptoms. The PANSS Marder Factor scores: positive symptoms is calculated from 8 items (for example: delusions, conceptual disorganization and stereotype thinking). Symptom severity was rated on a 7-point scale, from 1=absent to 7=extreme. Higher score indicating greater severity of symptoms

  9. Change From Baseline to Week 6 in PANSS Marder Factor Scores: Disorganized Thoughts [ Time Frame: Baseline and Week 6 ]
    The Positive and Negative Syndrome Scale (PANSS) is a clinician rated scale designed to measure severity of psychopathology in adult patients with schizophrenia, schizoaffective disorders and other psychotic disorders. It emphasizes positive and negative symptoms. The PANSS Marder Factor scores: disorganized thoughts is calculated from 7 items (for example: conceptual disorganization, difficulty in abstract thinking and mannerisms and posturing). Symptom severity was rated on a 7-point scale, from 1=absent to 7=extreme. Higher score indicating greater severity of symptoms

  10. Change From Baseline to Week 6 in PANSS Marder Factor Scores: Uncontrolled Hostility/Excitement [ Time Frame: Baseline and Week 6 ]
    The Positive and Negative Syndrome Scale (PANSS) is a clinician rated scale designed to measure severity of psychopathology in adult patients with schizophrenia, schizoaffective disorders and other psychotic disorders. It emphasizes positive and negative symptoms. The PANSS Marder Factor scores: uncontrolled hostility/excitement is calculated from 4 items (for example: excitement, hostility, and uncooperativeness).Symptom severity was rated on a 7-point scale, from 1=absent to 7=extreme. Higher score indicating greater severity of symptoms

  11. Change From Baseline to Week 6 in PANSS Marder Factor Scores: Anxiety/Depression [ Time Frame: Baseline and Week 6 ]
    The Positive and Negative Syndrome Scale (PANSS) is a clinician rated scale designed to measure severity of psychopathology in adult patients with schizophrenia, schizoaffective disorders and other psychotic disorders. It emphasizes positive and negative symptoms. The PANSS Marder Factor scores: anxiety/depression is calculated from 4 items (for example: anxiety, guilt feelings, and tension). Symptom severity was rated on a 7-point scale, from 1=absent to 7=extreme. Higher score indicating greater severity of symptoms

  12. Discontinuation Due to Lack of Efficacy During the Study [ Time Frame: Baseline to Week 6 ]
    Discontinuation due to lack of efficacy was based on the primary reason for withdrawal

  13. Response Rate at Week 6 [ Time Frame: Baseline and Week 6 ]
    The response rate was defined as a reduction of ≥30% from baseline in PANSS total score OR a CGI-I score of 1 or 2

  14. Change From Baseline to Week 6 in PSP Total Score [ Time Frame: Baseline and Week 6 ]
    The Personal and Social Performance Scale (PSP) is a clinician-rated scale designed and validated to measure a patient's current level of social functioning. The PSP scale consists of a 100-point single-item rating scale, subdivided into 10 equal intervals. Scores of 1 to 10 indicate lack of autonomy in basic functioning, whereas scores of 91 to 100 reflect excellent functioning. The total score is rated by the investigator and is based on an algorithm which takes both the ratings of the 4 primary domains of PSP, and the combination of these ratings into account. The 4 primary domains are: socially useful activities (including work and study), personal and social relationships, self-care, and disturbing and aggressive behaviours. The 4 domains are assessed on a 6-point scale, from absent to very severe. A higher score indicates a better performance.

  15. PSP Functional Remission Rate at Week 6 [ Time Frame: Week 6 ]
    The PSP functional remission rate was defined as a PSP total score ≥71

  16. PSP Functional Response Rate at Week 6 [ Time Frame: Week 6 ]
    The PSP functional response rate was defined as ≥10 point improvement from Baseline on the PSP total score

  17. PSP Domain D: Disturbing and Aggressive Behaviours at Week 6 [ Time Frame: Week 6 ]
    PSP domain D: disturbing and aggressive behaviours were categorised as "aggressive" (corresponding to mild, manifest, marked, severe, or very severe) or "nonaggressive" (corresponding to absent)



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • The patient has schizophrenia, diagnosed according to DSM-IV-TR™ and confirmed by the Mini International Neuropsychiatric Interview (MINI).
  • The patient has an acute exacerbation of psychotic symptoms and marked deterioration of usual function.
  • The patient is willing to be hospitalised from the Screening Visit through Week 6.
  • The patient will benefit from hospitalisation or continued hospitalisation for treatment of a current acute relapse of schizophrenia at study entry.
  • The patient has a history of relapse and/or exacerbation of symptoms when not receiving antipsychotic treatment, excluding the current episode.
  • The patient agrees to protocol-defined use of effective contraception.

Exclusion Criteria:

  • The patient has a current Axis I diagnosis (DSM-IV-TR™ criteria) other than schizophrenia established as primary diagnosis.
  • The patient suffers from a current Axis II diagnosis (DSM-IV-TR™ criteria).
  • The patient suffers from mental retardation, organic mental disorders, or mental disorders due to a general medical condition (DSM-IV-TR™ criteria).
  • The patient, in the opinion of the investigator or according to Columbia Suicide Severity Rating Scale (C-SSRS), is at significant risk of suicide.
  • The patient has clinically significant tardive dyskinesia or severe akathisia at enrolment.
  • The patient has a history of neuroleptic malignant syndrome.
  • The patient has any relevant medical history or current presence of systemic disease.
  • The patient has, at the Screening Visit an abnormal ECG or other abnormal ECG tests that are, in the investigator's opinion, clinically significant.
  • The patient has a history of cancer, other than basal cell or Stage 1 squamous cell carcinoma of the skin, that has not been in remission for >5 years prior to the first dose of brexpiprazole.
  • The patient is, in the investigator's opinion, unlikely to comply with the protocol or is unsuitable for any reason.

Other inclusion and exclusion criteria may apply.


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): NCT01810380


Locations
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United States, California
US009
Escondido, California, United States, 92025
Sponsors and Collaborators
H. Lundbeck A/S
Otsuka Pharmaceutical Co., Ltd.
Investigators
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Study Director: Email contact via H. Lundbeck A/S LundbeckClinicalTrials@lundbeck.com

Additional Information:
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Responsible Party: H. Lundbeck A/S
ClinicalTrials.gov Identifier: NCT01810380     History of Changes
Other Study ID Numbers: 14644A
2012-002252-17 ( EudraCT Number )
First Posted: March 13, 2013    Key Record Dates
Results First Posted: March 29, 2016
Last Update Posted: March 16, 2017
Last Verified: February 2017

Additional relevant MeSH terms:
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Brexpiprazole
Schizophrenia
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders
Quetiapine Fumarate
Antidepressive Agents
Psychotropic Drugs
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Dopamine Agonists
Dopamine Agents