Interventional, Open-label, Two-way Crossover, Single-dose Study Investigating the Absolute Bioavailability and Food Effect on the Pharmacokinetics of Lu AF35700 in Healthy Subjects

The purpose of this study is to investigate the extent to which Lu AF35700 enters the bloodstream following pill intake and the influence of food on the uptake in healthy men and women

Start Date05 Sep 2018

Sponsor / Collaborator

H. Lundbeck A/S

NCT03394482

/ CompletedPhase 1

Interventional, Randomized, Open-label, Three-group, Two-sequence Crossover, Single-dose, Bioequivalence Study of Lu AF35700 in Healthy Subjects Comparing the 5, 10 and 20 mg Commercial Tablet (Test) to the 5, 10 and 20 mg Clinical Tablet (Reference)

The purpose of this study is to establish bioequivalence of Lu AF35700 between the clinical formulation and the commercial formulation for three tablet strengths; 5, 10 and 20 mg

Start Date03 Jan 2018

Sponsor / Collaborator

H. Lundbeck A/S

NCT03241147

/ TerminatedPhase 1

Interventional, Open Label, Reduced/Staged, Single Dose Study Investigating the Pharmacokinetic Properties of Lu AF35700 in Subjects With Renal Impairment and in Healthy Subjects

This study will evaluate the pharmacokinetics of Lu AF35700 after a single dose tablet to subjects with renal impairment (kidney insufficiency) and compare that with healthy subjects

Start Date25 Jul 2017

Sponsor / Collaborator

H. Lundbeck A/S

100 Clinical Results associated with Lu-AF-35700

100 Translational Medicine associated with Lu-AF-35700

100 Patents (Medical) associated with Lu-AF-35700

Literatures (Medical) associated with Lu-AF-35700

01 Aug 2023·European journal of pharmacology

Lu AF35700 reverses the phencyclidine-induced disruption of thalamo-cortical activity by blocking dopamine D1 and D2 receptors

Article

Author: Artigas, Francesc ; Celada, Pau ; Didriksen, Michael ; Riga, Maurizio S ; Paz, Veronica

Antipsychotic drugs of different chemical/pharmacological families show preferential dopamine (DA) D₂ receptor (D₂-R) vs. D₁ receptor (D₁-R) affinity, with the exception of clozapine, the gold standard of schizophrenia treatment, which shows a comparable affinity for both DA receptors. Here, we examined the ability of Lu AF35700 (preferential D₁-R>D₂-R antagonist), to reverse the alterations in thalamo-cortical activity induced by phencyclidine (PCP), used as a pharmacological model of schizophrenia. Lu AF35700 reversed the PCP-induced alteration of neuronal discharge and low frequency oscillation (LFO, 0.15-4 Hz) in thalamo-cortical networks. Likewise, Lu AF35700 prevented the increased c-fos mRNA expression induced by PCP in thalamo-cortical regions of awake rats. We next examined the contribution of D₁-R and D₂-R to the antipsychotic reversal of PCP effects. The D₂-R antagonist haloperidol reversed PCP effects on thalamic discharge rate and LFO. Remarkably, the combination of sub-effective doses of haloperidol and SCH-23390 (DA D₁-R antagonist) fully reversed the PCP-induced fall in thalamo-cortical LFO. However, unlike with haloperidol, SCH-23390 elicited different degrees of potentiation of the effects of low clozapine and Lu AF35700 doses. Overall, the present data support a synergistic interaction between both DA receptors to reverse the PCP-induced alterations of oscillatory activity in thalamo-cortical networks, possibly due to their simultaneous blockade in direct and indirect pathways of basal ganglia. The mild potentiation induced by SCH-23390 in the case of clozapine and Lu AF35700 suggests that, at effective doses, these agents reverse PCP effects through the simultaneous blockade of both DA receptors.

01 Oct 2022·Schizophrenia research

Efficacy and safety of Lu AF35700 in treatment-resistant schizophrenia: A randomized, active-controlled trial with open-label extension

Article

Author: Pedro Such ; Carlos Forray ; Ole M. Lemming ; John M. Kane ; Peter Hertel ; Bruce J. Kinon ; Aurélia Mittoux ; Oliver D. Howes

INTRODUCTION:

Treatment resistance constitutes the highest burden of disease within schizophrenia. We hypothesized that the synergistic activity of Lu AF35700 at dopamine D₁ and D₂ receptors might provide superior antipsychotic effects versus first-line antipsychotic therapy in patients with treatment resistant schizophrenia (TRS), with a benign tolerability profile.

METHODS:

This was a randomized, double-blind, active-controlled clinical trial (NCT02717195) followed by a one year open-label safety extension (NCT02892422). Following prospective confirmation of treatment resistance, patients were randomized (1:1:1) to 10 weeks double-blind treatment with Lu AF35700 10 mg or 20 mg, or active comparator (risperidone or olanzapine).

RESULTS:

1628 patients were screened for TRS, of which 1092 entered the prospective confirmation period. Of these, 697 were randomized (Lu AF35700 10 mg n = 235, 20 mg n = 232, comparator n = 230) and 395 discontinued before randomization, including 264 (24 %) who responded to treatment. 586 patients completed the double-blind phase, of which 524 entered the open-label extension and 318 completed 1-year of open-label treatment. At the end of the double-blind phase, the mean ± SE change in positive and negative syndrome scale (PANSS) total score was -10.1 ± 0.96 for Lu AF35700 10 mg, -8.22 ± 0.98 for Lu AF35700 20 mg, and - 9.90 ± 0.97 for the comparator group. Treatment differences [95 % CI] versus comparator treatment were non-significant (-0.12 [-2.37; 2.13] and 1.67 [-0.59; 3.94], respectively). The most common adverse events with Lu AF35700 were increased weight and headache. Prolactin values decreased by ≥50 % in both sexes treated with Lu AF35700.

CONCLUSIONS:

Despite evidence of antipsychotic efficacy, treatment with Lu AF35700 failed to differentiate from conventional antipsychotic treatment for patients with TRS.

01 Sep 2022·Bioorganic & medicinal chemistry letters

Distal kinetic deuterium isotope effect: Phenyl ring deuteration attenuates N-demethylation of Lu AF35700

Article

Author: Tornby Christoffersen, Claus ; Didriksen, Michael ; Gjervig Jensen, Klaus ; Graulund Hvenegaard, Mette ; Jørgensen, Morten

The N-demethylation of zicronapine (7) and three of its deuterated analogs 8 - 10 has been studied in human in vitro metabolism systems. While the N-deuterio-methyl analog 8 did not behave differently from the parent in human liver microsomes, a significantly reduced rate of N-demethylation was observed as a consequence of benzene ring deuteration (compound 7vs.9). Additional deuteration of the N-methyl group, which as mentioned had shown no effect in isolation, further decreased the rate of the N-demethylation reaction (compound 10vs.9). This paper presents and discusses this unprecedented 'distal kinetic isotope effect' that was observed when incubating the test compounds with human liver microsomes or recombinant human CYP450 liver enzymes.

News (Medical) associated with Lu-AF-35700

06 Aug 2020

·www.biospace.com

Lundbeck Discontinues Phase II Schizophrenia Study Following Interim Analysis

Denmark-based Lundbeck discontinued a mid-stage proof of concept study of a schizophrenia drug following an interim analysis of data that indicated the study will not achieve statistical significance in its primary endpoint. Denmark-based Lundbeck discontinued a mid-stage proof of concept study of a schizophrenia drug following an interim analysis of data that indicated the study will not achieve statistical significance in its primary endpoint. Lundbeck announced this morning it will halt the Phase II study of its experimental asset Lu AF11167, a selective inhibitor of the phosphodiesterase 10A enzyme (PDE10Ai), which modulates dopamine D1 and D2 receptor-mediated intraneuronal signaling without binding to these receptors. The asset was being studied as a potential treatment of patients with schizophrenia, who are experiencing persistent negative symptoms. PDE10Ai is believed to reduce negative symptoms and to keep positive symptoms stabilized. There are no approved treatments for this particular indication, Lundbeck said. Lundbeck halted the trial following a futility interim analysis, which concluded that the trial is unlikely to achieve statistical significance on its primary endpoint, mean change from baseline to week 12 on the Brief Negative Symptom Scale (BNSS). Lundbeck said there were no safety issues involved with the decision to terminate the trial. Results of the halted study will be published at a future date, the company said. “It is disappointing that Lu AF11167 did not show the efficacy needed to treat this area which impacts many patients and represents a huge unmet medical need. We are very grateful for the patients and the clinical study sites that participated in this proof of concept study. The outcome from this interim analysis helps us to prioritize Lundbeck´s resources towards opportunities that have the highest promise for our patients. We will now close the study in a responsible manner and ensure that valuable knowledge gathered is made accessible to researchers globally,” Johan Luthman, Lundbeck’s head of R&D said in a statement. The primary objective of the phase II study was to evaluate the efficacy on negative symptoms of two doses of Lu AF11167 versus placebo as monotherapy in patients with schizophrenia and persistent prominent negative symptoms. The secondary objective was to evaluate the efficacy of Lu AF11167 on patients’ functioning as well as the safety and tolerability of the compound. In 2018, Lundbeck saw another disappointing clinical result in schizophrenia. A Phase III assessment of Lu AF35700 failed to differentiate itself against conventional schizophrenia therapies. It is estimated that more than 21 million people across the globe suffer from schizophrenia, a mental illness caused by an imbalance in the neurotransmitters facilitating the communication between neurons in the brain. That imbalance causes schizophrenia patients to perceive things that are not real. People with schizophrenia experience disturbed thoughts, emotions and behavior, and they find it difficult to judge reality. Negative symptoms, a diminution or absence of normal behaviors related to motivation and interest or expression, are a core component of schizophrenia and they account for a large part of the long-term morbidity and poor functional outcome in patients with the disorder.

Phase 2Phase 3

26 Oct 2018

·www.biospace.com

Lundbeck Schizophrenia Drug Fails to Differentiate Itself from Conventional Therapies, Stocks Plunge

Red trend as symbol of business recession and financial crisis. Large resolution Arsgera/Getty Images/iStockphoto Shares of H. Lundbeck A/S plunged more than 25 percent after the company announced Thursday that its Phase III treatment for treatment-resistant schizophrenia failed to differentiate itself against conventional therapies. Shares of H. Lundbeck A/S plunged more than 25 percent after the company announced Thursday that its Phase III treatment for treatment-resistant schizophrenia failed to differentiate itself against conventional therapies. The company was studying Lu AF35700 , a novel, once-per-day oral antipsychotic drug candidate as a potential therapy for schizophrenia patients who have been difficult to treat. However, the company noted that the Phase III drug candidate did not meet the primary endpoint of statistical superiority vs conventional therapy. Lundbeck was evaluating its drug candidate against two common medications for treatment-resistant schizophrenia, risperidone or olanzapine. That announcement caused share prices to tumble. The stock fell from $60.85 to a close of $46.16. That wiped out about $4 billion in market value for the Denmark-based company. It was the worst selloff in company history, Bloomberg reported. Anders Gersel Pedersen, head of researcher and development at Lundbeck, said treatment-resistant schizophrenia is the “highest burden of disease within schizophrenia” for patients and society. Treatment-resistant schizophrenia is associated with poor prognosis and functional outcomes. Individuals with treatment-resistant schizophrenia are at increased risk of hospitalization, unemployment, homelessness, aggression, imprisonment, substance abuse, violent victimization, and suicide, according to Lundbeck. With Lu AF35700, the company had hoped to show that it was a superior treatment to medications already on the market, he said. Things looked hopeful for the drug when the U.S. Food and Drug Administration granted Lu AF35700 Fast Track designation three years ago. “This is a setback for patients with schizophrenia, but we will continue to advance our pipeline of innovative therapies to meet the needs of patients suffering from psychiatric and neurological diseases,” Pederson said. Lu AF35700, an antagonist at dopaminergic, serotonergic, and α adrenergic receptors, was being studied in the Phase III DAYBREAK 1 trial, a double-blind randomized and active-controlled study evaluating the efficacy and safety of the medication. Over a 10 week period, nearly 1,000 patients with treatment-resistant schizophrenia were dosed with either the Lundbeck drug or control. Lundbeck said the target treatment-resistant schizophrenia population was patients who met the DSM-5 criteria for schizophrenia who experienced ongoing psychotic symptomatology and demonstrated a lack of satisfactory clinical improvement to at least two different antipsychotics given at an adequate dose and duration. While the drug did not show statistical superiority against the two conventional treatments, Lundbeck noted that Lu AF35700 demonstrated “good anti-psychotic effects” during the study. The company said it will continue to analyze the data. Lu AF35700 was safe and generally well-tolerated at 10 mg and 20 mg doses during the study with no unexpected adverse events reported, Lundbeck said.

Phase 3Clinical ResultFast TrackPhase 2

25 Oct 2018

·www.globenewswire.com

Lundbeck updates on clinical phase III study for Lu AF35700 in Treatment-Resistant Schizophrenia

Valby, Oct. 25, 2018 (GLOBE NEWSWIRE) -- Corporate Release Lundbeck updates on clinical phase III study for Lu AF35700 in Treatment-Resistant Schizophrenia Lu AF35700 did not show statistical superiority versus conventional therapy on the primary endpoint (change in Total PANSS) in patients with treatment-resistant schizophrenia (TRS)Lu AF35700 showed good anti-psychotic effects, was well-tolerated and safe at 10 mg and 20 mg dosages in the studyFurther analysis of the data is ongoing Valby, Denmark, 25 October 2018 - H. Lundbeck A/S (Lundbeck) today announced that DAYBREAKi, the first phase III study for Lu AF35700, an investigational, novel, once-daily, oral antipsychotic drug candidate for the potential treatment of treatment-resistant schizophrenia (TRS), did not meet the primary endpoint of statistical superiority vs conventional therapy. Lu AF35700 was safe and generally well-tolerated in the study with no unexpected adverse events reported. “TRS constitutes the highest burden of disease within schizophrenia for patients, their families and society and we had with Lu AF35700 hoped to show superiority against conventional therapy”, says Anders Gersel Pedersen, Executive Vice President, Research and Development at Lundbeck; “this is a setback for patients with schizophrenia, but we will continue to advance our pipeline of innovative therapies to meet the needs of patients suffering from psychiatric and neurological diseases.” DAYBREAK was a multinational, double-blind, randomized, active-controlled phase III study that evaluated the antipsychotic efficacy, safety and tolerability of Lu AF35700 compared to an active-controlled arm over ten weeks in 964 patients with TRS. About DAYBREAK I The safety and efficacy of Lu AF35700 in patients with TRS was assessed in a 10-week, double-blind, randomised, active-controlled trial. The target TRS population for randomization was patients who met the DSM-5 criteria for schizophrenia who experienced ongoing psychotic symptomatology and demonstrated a lack of satisfactory clinical improvement to at least two different antipsychotics given at an adequate dose and duration. The study included a single-blinded prospective treatment period of patients with persistent psychotic symptomatology who had at least one adequate and well-documented antipsychotic treatment trial without a satisfactory clinical improvement were treated for 6 weeks with either risperidone (4mg to 6mg/day) or olanzapine (15mg to 20mg/day) to confirm their resistance to antipsychotic treatment. Patients who did not fulfil the pre-specified response criteria in the prospective treatment period were considered treatment-resistant and were eligible to enter the double-blind treatment period were patients were randomly assigned to 10 weeks of daily treatment with either Lu AF35700 10mg (n=235), Lu AF35700 20 mg (n=232) or to continued treatment with risperidone or olanzapine (n=230). The primary efficacy endpoint was change from randomisation to Week 10 of the double-blind treatment period in PANSS total score. About Lu AF35700 Lu AF35700 is an antagonist at dopaminergic, serotonergic, and α adrenergic receptors. Unlike all currently available antipsychotics, Lu AF35700 has higher affinity for the human dopamine D1 receptor than it has for the human dopamine D2 receptor. In TRS, the higher ratio of dopamine D1 vs. D2 receptor activity is hypothesized to result in a beneficial efficacy profile and a tolerability profile without the troublesome side effects associated with extensive dopamine D2 receptor blockade, such as extrapyramidal symptoms. In November 2015, FDA granted Fast Track designation for Lu AF35700 — a first important step to ensure a potential expedited approval of the compound. About treatment-resistant schizophrenia (TRS) Treatment-resistant schizophrenia (TRS) is broadly defined in clinical guidelines as no or minimal clinical improvement in target schizophrenia symptoms following treatment with ≥2 anti-psychotic treatments of adequate dose and durationii, [iii], [iv], [v], [vi]. About one-third of patients with schizophrenia have TRS with persistent core positive symptoms of at least moderate severity despite treatment with antipsychoticsvii, [viii], [ix]. TRS is among the most highly disabling psychiatric disorders for both patients and caregivers, and imposes the greatest impairment in the patients’ community functioning and psychosocial adjustmentx, [xi]. TRS is associated with poor prognosis and functional outcomes, and individuals with TRS are at increased risk of hospitalization, unemployment, homelessness, aggression, imprisonment, substance abuse, violent victimization, and suicidexii, [xiii], [xiv]. Lundbeck contactsInvestors: Media:Palle Holm Olesen Mads KronborgVice President, Investor Relations Senior Director, Corp. CommunicationPALO@lundbeck.com MAVK@lundbeck.com+45 30 83 24 26 +45 36 43 40 00 About H. Lundbeck A/SH. Lundbeck A/S (LUN.CO, LUN DC, HLUYY) is a global pharmaceutical company specialized in psychiatric and neurological disorders. For more than 70 years, we have been at the forefront of research within neuroscience. Our key areas of focus are Alzheimer's disease, depression, Parkinson's disease and schizophrenia. Our approximately 5,000 employees in 55 countries are engaged in the entire value chain throughout research, development, manufacturing, marketing and sales. Our pipeline consists of several late-stage development programmes and our products are available in more than 100 countries. We have production facilities in Denmark, France and Italy. Lundbeck generated revenue of DKK 17.2 billion in 2017 (EUR 2.3 billion; USD 2.6 billion). For additional information, we encourage you to visit our corporate site www.lundbeck.com and connect with us on Twitter at @Lundbeck. Safe Harbor/Forward-Looking StatementsThe above information contains forward-looking statements that provide our expectations or forecasts of future events such as new product introductions, product approvals and financial performance. Such forward-looking statements are subject to risks, uncertainties and inaccurate assumptions. This may cause actual results to differ materially from expectations and it may cause any or all of our forward-looking statements here or in other publications to be wrong. Factors that may affect future results include interest rate and currency exchange rate fluctuations, delay or failure of development projects, production problems, unexpected contract breaches or terminations, government-mandated or market-driven price decreases for Lundbeck's products, introduction of competing products, Lundbeck's ability to successfully market both new and existing products, exposure to product liability and other lawsuits, changes in reimbursement rules and governmental laws and related interpretation thereof, and unexpected growth in costs and expenses. Certain assumptions made by Lundbeck are required by Danish Securities Law for full disclosure of material corporate information. Some assumptions, including assumptions relating to sales associated with product that is prescribed for unapproved uses, are made taking into account past performances of other similar drugs for similar disease states or past performance of the same drug in other regions where the product is currently marketed. It is important to note that although physicians may, as part of their freedom to practice medicine in the US, prescribe approved drugs for any use they deem appropriate, including unapproved uses, at Lundbeck, promotion of unapproved uses is strictly prohibited. i NCT02717195: Effect of Lu AF35700 in Patients With Treatment-resistant Schizophrenia (DayBreak) ii Lehman AF, Lieberman JA, Dixon LB, McGlashan TH, Miller AL, Perkins DO, Kreyenbuhl J; American Psychiatric Association; Steering Committee on Practice Guidelines. Practice guideline for the treatment of patients with schizophrenia, second edition. Am J Psychiatry. 2004;2 Suppl:1-56 iii Hasan A, Falkai P, Wobrock T, Lieberman J, Glenthoj B, Gattaz WF, Thibaut F, Möller HJ; World Federation of Societies of Biological Psychiatry (WFSBP) Task Force on Treatment Guidelines for Schizophrenia. World Federation of Societies of Biological Psychiatry (WFSBP) Guidelines for Biological Treatment of Schizophrenia, part 1: update 2012 on the acute treatment of schizophrenia and the management of treatment resistance. World J Biol Psychiatry. 2012;5:318-78. iv Howes, OD, McCutcheon, R, Agid, O, et al. 2017. Treatment-Resistant Schizophrenia: Treatment Response and Resistance in Psychosis (TRRIP) Working Group Consensus Guideline on Diagnosis and Terminology. Am J Psychiatry 174, 216–229. v Howes, OD, McCutcheon, R, Agid, O, et al. 2017. Treatment-Resistant Schizophrenia: Treatment Response and Resistance in Psychosis (TRRIP) Working Group Consensus Guideline on Diagnosis and Terminology. Am J Psychiatry 174, 216–229. vi National Institute for Health and Care Excellence. nice.org.uk/guidance/cg178. vii Barnes, et al. Treatment-resistant schizophrenia. In: Hirsch SR and Weinberger D (eds). Schizophrenia (pp 489–516). Oxford 2003: Blackwell Publishing. viii Conley R, Kelly D. Management of Treatment Resistance in Schizophrenia. Biol Psychiatry. 2001;11:898-911. ix Pantelis C, Lambert TJ. Managing patients with “treatment-resistant” schizophrenia. Med J Aust. 2003;Suppl:62-6. x Iasevoli F, Giordano S, Balletta R, Latte G, Formato MV, Prinzivalli E, De Berardis D, Tomasetti C, de Bartolomeis A. Treatment resistant schizophrenia is associated with the worst community functioning among severely-ill highly-disabling psychiatric conditions and is the most relevant predictor of poorer achievements in functional milestones. Prog Neuropsychopharmacol Biol Psychiatry. 2016;34-48. xi Brain C, Kymes S, DiBenedetti D, Brevig T, Velligan DI. Experiences, attitudes, and perceptions of caregivers of individuals wit treatment-resistant schizophrenia: a qualitative study. BMC Psychiatry 2018; 18:253. xii Brekke, Prindel, Bae, Long. Risks for individuals with schizophrenia who are living in the community. Psychiatry Serv. 2001; 52:1358-66. xiii Jones and Castle. Management of treatment resistant schizophrenia: a review article. Afr Psychiatry Rev. 2006;9:17-23 xiv Kennedy JL, Altar CA, Taylor DL, Degtiar I, Hornberger JC. The social and economic burden of treatment-resistant schizophrenia: a systematic literature review. Int Clin Psychopharmacol. 2014;2:63-76

Clinical ResultPhase 3Fast Track

100 Deals associated with Lu-AF-35700

R&D Status

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Indication	Highest Phase	Country/Location	Organization	Date
Schizophrenia, Treatment-Resistant	Phase 3	United States	H. Lundbeck A/S	01 Apr 2016
Schizophrenia, Treatment-Resistant	Phase 3	Bulgaria	H. Lundbeck A/S	01 Apr 2016
Schizophrenia, Treatment-Resistant	Phase 3	Canada	H. Lundbeck A/S	01 Apr 2016
Schizophrenia, Treatment-Resistant	Phase 3	Czechia	H. Lundbeck A/S	01 Apr 2016
Schizophrenia, Treatment-Resistant	Phase 3	Estonia	H. Lundbeck A/S	01 Apr 2016
Schizophrenia, Treatment-Resistant	Phase 3	Finland	H. Lundbeck A/S	01 Apr 2016
Schizophrenia, Treatment-Resistant	Phase 3	Mexico	H. Lundbeck A/S	01 Apr 2016
Schizophrenia, Treatment-Resistant	Phase 3	Poland	H. Lundbeck A/S	01 Apr 2016
Schizophrenia, Treatment-Resistant	Phase 3	Romania	H. Lundbeck A/S	01 Apr 2016
Schizophrenia, Treatment-Resistant	Phase 3	Russia	H. Lundbeck A/S	01 Apr 2016

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT02892422 (Debut, CTgov)	Phase 3	Schizophrenia	528	Lu AF35700	wqmwymufvs = ggdtmfxims ilnxidexjg (vxhkfxawlu, tkuellxpqv - voetsqucor)	-	26 Oct 2020
NCT02333487 (CTgov)	Phase 1	Schizophrenia	22	Lu AF35700 (Lu AF35700 (Group D1))	kkblwfqjad = rdsohralkb kcicnukkgw (rfxjdoqdda, ryxxxwcjdq - qlbhtnzrpg) View more	-	12 May 2020
				Lu AF35700 (Lu AF35700 (Group D2))	tryqmuxldx = fqkkclwguy wvupziaosd (mygwdnsaxk, fwyxqkhpsn - wywtybxhsg) View more
NCT03230864 (Anew, CTgov)	Phase 3	Schizophrenia, Treatment-Resistant	119	Lu AF35700 (Double-blind Treatment (DBT) Period, Lu AF35700 10 mg)	khiquqixyi(kkcfypuecu) = ejxebgzqou ydbcihmpdm (aasfvkxazp, 2.22)	-	07 Jan 2020
				risperidone+Olanzapine (DBT Period, Continued Treatment From PC Period)	dlzxlgaznn(lojoygistn) = ervwidtjfv qvvcundkcc (blsiohlpgc, ghjjcuscoz - odrpqanjed) View more
NCT02717195 (DAYBREAK, CTgov)	Phase 3	Schizophrenia, Treatment-Resistant	1,098	Lu AF35700 (Double-blind Treatment (DBT) Period, Lu AF35700 10 mg)	hzzavpabwd(jxxpwlwlik) = qzilpakuyj njoechzpio (nbjzfqfqpd, 0.96) View more	-	25 Nov 2019
				Lu AF35700 (DBT Period, Lu AF35700 20 mg)	hzzavpabwd(jxxpwlwlik) = ylhlkifwlt njoechzpio (nbjzfqfqpd, 0.98) View more
NCT02717195 (DAYBREAK, GlobeNewswire) Manual	Phase 3	Schizophrenia, Treatment-Resistant	964	Lu AF35700	gcaflgfmlt(dptlmigcth) = No statistical superiority vs conventional therapy frmswnvvtw (bdwsdhbkfa ) View more	Non-superior	25 Oct 2018
				risperidone or olanzapine

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