Phase 3
Completed N=1,098
Effect of Lu AF35700 in Patients With Treatment-resistant Schizophrenia
Source: ClinicalTrials.gov NCT02717195 ↗Enrolled (actual)
1,098
Serious AEs
2.1%
Results posted
Nov 2019
Primary outcomePrimary: Change From Randomization to Week 10 in Positive and Negative Syndrome Scale (PANSS) Total Score — -10.01; -8.22; -9.90 units on a scale — p=0.9196
◆ Published Evidence
Emerging
12citations · ~3 / year
Efficacy and safety of Lu AF35700 in treatment-resistant schizophrenia: A randomized, active-controlled trial with open-label extension.
Summary
To evaluate the efficacy of 10 and 20 mg/day of Lu AF35700 on schizophrenia symptoms in patients with treatment-resistant schizophrenia (TRS)
Linked Publications
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Efficacy and safety of Lu AF35700 in treatment-resistant schizophrenia: A randomized, active-controlled trial with open-label extension.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Randomization to Week 10 in Positive and Negative Syndrome Scale (PANSS) Total Score |
-10.01; -8.22; -9.90 | 0.9196 |
| SECONDARY Change From Randomization to Week 10 in PSP Total Personal and Social Performance (PSP) Total Score |
4.90; 3.23; 3.94 | 0.2998 |
| SECONDARY Change From Randomization to Week 10 in Global Clinical Impression - Severity of Illness (CGI-S) Score |
-0.59; -0.54; -0.57 | — |
| SECONDARY Response at Week 10, Defined as ≥20% Reduction in PANSS Total Score, PANSS (Positive and Negative Syndrome Scale) Total Score ≤70, CGI-S (Clinical Global Impression Scale - Severity of Illness) Score <4 |
21; 18; 12 | — |
| SECONDARY Response at Week 10, Defined as ≥20% Reduction in Positive and Negative Syndrome Scale (PANSS) Total Score From Randomization |
82; 59; 77 | — |
| SECONDARY Response at Week 10, Defined as ≥30% Reduction in PANSS Total Score From Randomization |
42; 30; 45 | — |
| SECONDARY Response at Week 10, Defined as ≥40% Reduction in Positive and Negative Syndrome Scale (PANSS) Total Score From Randomization |
23; 15; 16 | — |
| SECONDARY Response at Week 10, Defined as ≥50% Reduction in Positive and Negative Syndrome Scale (PANSS) Total Score From Randomization |
10; 4; 6 | — |
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT02717195) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.