A phase II pilot study of fosaprepitant (F) for the rescue of acute nausea and vomiting with moderately (MEC) or highly emetogenic chemotherapy (HEC) in adults.

2013 ◽  
Vol 31 (15_suppl) ◽  
pp. e20627-e20627
Author(s):  
Joseph S. Bubalo ◽  
Ian D. Schnadig ◽  
Gabrielle Meyers ◽  
Andy I. Chen ◽  
Brandon M. Hayes-Lattin ◽  
...  
Keyword(s):  
Study Design ◽  
Primary Endpoint ◽  
Rescue Medication ◽  
Rescue Therapy ◽  
Single Agent ◽  
Nausea And Vomiting ◽  
Attractive Potential ◽  
Success Rates ◽  
Delayed Nausea ◽  
Rescue Agent

e20627^ Background: Patients receiving MEC or HEC continue to have breakthrough nausea and emesis despite antiemetic prophylaxis. Few trials have evaluated the efficacy of rescue antiemetics after failed prophylaxis. F, a prodrug of the neurokinin-1 antagonist (NK1a), aprepitant is FDA-approved for the prevention of acute and delayed nausea and vomiting associated with MEC and HEC. F’s safety and efficacy in the prophylactic setting make F an attractive potential rescue therapy. Methods: F 150mg was infused as the initial rescue agent in eligible patients receiving MEC or HEC who had either emesis or nausea despite guideline-based prophylaxis with a 5HT-3 antagonist and dexamethasone. The primary endpoint was improved nausea on a visual analogue scale (VAS) at 2 hours. Secondary endpoints included: VAS at 12 and 24 hrs, rescue medication use, emesis, nutritional intake, adverse events, and proof of the study design as a viable methodology. Results: Eleven adult patients, 6 males and 5 females, were treated per protocol and evaluable for the 24 hour study period. Chemotherapy regimens included HiDAC, R-CHOP, epirubicin/ifosfamide, EPOCH, R-ICE, 7+3, VAC, and HyperCVAD. 3 patients were treated for emesis and 8 for nausea. 91% of patients had improved nausea at 2 hrs, 100% at 12 hrs and 63.6% at 24 hrs. F prevented further emesis in 2 of 3 patients and no patient with initial nausea had subsequent emesis. 9 of 11 (81.8%) patients required additional rescue medication during the study period, mainly due to nausea. Appetite was improved in 8/11 patients. Food and fluid intake improved in 5/11. Adverse effects included headache 18%, dizziness 18%, hiccups 9%, indigestion 9%, and 1 case ifosfamide encephalopathy. The study design required greater than anticipated consented patients due to the success rates of standard antiemetic therapy. Conclusions: F improves breakthrough nausea and related symptoms, and may prevent further emesis but was suboptimal as a single agent in that the majority of patients required a second rescue agent within 24 hrs. Complete response, defined as no emesis and no rescue therapy, may be a more clinically relevant primary endpoint in future trial designs. Clinical trial information: NCT00939302.

Steroid-free regimen with aprepitant in preventing chemotherapy-induced nausea and vomiting in patients with colorectal cancer receiving FOLFOX chemotherapy: A randomized phase III trial.

2017 ◽  
Vol 35 (4_suppl) ◽  
pp. TPS820-TPS820
Author(s):  
Wenjing Wang ◽  
Jiayu Ling ◽  
Yue Cai ◽  
Jianwei Zhang ◽  
Huabin Hu ◽  
...  
Keyword(s):  
Colorectal Cancer ◽  
Receptor Antagonist ◽  
Rescue Medication ◽  
Performance Status ◽  
Nausea And Vomiting ◽  
Phase Iii ◽  
Open Label ◽  
Phase Iii Trial ◽  
Delayed Nausea ◽  
To Receive

TPS820 Background: Addition of aprepitant, an NK1 receptor antagonist to a 5-HT3 receptor antagonist and dexamethasone regimen was shown to be effective for prevention of chemotherapy-induced nausea and vomiting (CINV) with moderately emetogenic chemotherapy (MEC). Little is known about the efficacy of aprepitant when used without dexamethasone. Dexamethasone is widely used to prevent both acute and delayed nausea and vomiting induced by chemotherapy. However, multi-period use of dexamethasone could be associated with side effect, such as hyperglycemia, dyspepsia and insomnia. This randomized phase III trial studies antiemetic therapy with aprepitant and tropisetron to see how well they work compared to dexamethasone plus tropisetron in preventing chemotherapy-induced nausea and vomiting in patients with colorectal cancer receiving FOLFOX (oxaliplatin, leucovorin and 5-fluorouracil) chemotherapy. Methods: This trial is an open-label, single-center, randomized phase 2 study. Eligibility criteria include histologically confirmed colorectal cancer, no prior chemotherapy and scheduled to receive FOLFOX, Age ≥ 18 years, ECOG Performance Status 0, 1 or 2. Up to 298 patient will be enrolled and randomized 1:1 to receive aprepitant (125 mg orally on day 1 and 80 mg orally on days 2 and 3) plus tropisetron (5mg IV of day1) or dexamethasone (10 mg IV on day 1 and 5 mg IV on days 2, 3) plus Tropisetron (5mg IV of day1). The primary objective of this study is complete response defined as no emetic episodes and no use of rescue medication. The second objectives include nausea score, time to first vomiting episode or use of rescue medication, frequency of rescue medication and functional Living Index -Emesis (FLIE). Clinical trial information: NCT02909478.

Is gabapentin effective for preventing delayed nausea and vomiting (NV) after moderately and highly emetogenic chemotherapy (CT)?

2006 ◽  
Vol 24 (18_suppl) ◽  
pp. 18575-18575
Author(s):  
A. Menendez-Leal ◽  
C. Quijano ◽  
A. G. Menendez-Rivera
Keyword(s):  
Side Effects ◽  
Primary Endpoint ◽  
Emetogenic Chemotherapy ◽  
The Other ◽  
Nausea And Vomiting ◽  
Highly Emetogenic Chemotherapy ◽  
Good Tolerability ◽  
Other Hand ◽  
Delayed Nausea ◽  
Financial Relationships

18575 Background: Following previous institutional observations,this protocol was designed to evaluate the efficacy of Gabapentin in the prophylaxis of delayed CT induced NV. Methods: The main elegibility criteria was moderate and severe NV on previous CT cycles.Gabapentin 300 mg caps. was given as follows: One capsule day -2, two capsules day -1 and one capsule tid from days 1 to 5. 24 pats. were evaluated; 22 (92%) female, 2 (8%) male.CT included Doxorubicin/Ciclofosfamide 15 (62.5%), Cis-Platin 5 (21%), Other regimens 4 (17%). Previous prophylaxis for all pats. included a 5-HT3 Antagonist plus Dexametasone. Pats. were instructed to complete a two-page Questionaire: On page 1 pats. indicated the intensity of nausea according a scale shown there. On page two they indicated the number of vomits they had.This was made three times daily for five days. The primary endpoint was reduction of NV aftyer CT. Results: The reduction observed in the number of vomits was as follows: Number of pats. that experienced 0 Vomits: day 1 (CT): 14 (58.3%); day 2: 18 (75%); day 3: 20 (83.3%); day 4: 18 (75%); day 5: 22 (91.7%). On the other hand, pats. that did not respond and had three or more vomits daily: day 1: 5 (20.8%); day 2: 2 (8.3%); day 3: 1 (4.2%); day 4: 3 (12.5%); day 5: 2 (8.3%).Most pats. experienced a decrease in the intensity of nausea as well. No significant side effects were seen. Conclusions: Gabapentin seems to have some efficacy preventing delayed NV after moderately and highly emetogenic CT. These results together with it’s possible effect on acute NV and good tolerability warrant further studies. No significant financial relationships to disclose.

Nausea and vomiting during high-dose interleukin-2 (HD IL-2) therapy.

2013 ◽  
Vol 31 (15_suppl) ◽  
pp. e20661-e20661
Author(s):  
Mark Fesler ◽  
Melinda Bernabe Chu ◽  
Eric Armbrecht ◽  
Scott Fosko ◽  
Eddy C. Hsueh ◽  
...  
Keyword(s):  
Acute Phase ◽  
Drug Targets ◽  
Rescue Medication ◽  
Rescue Therapy ◽  
Interleukin 2 ◽  
Retrospective Chart Review ◽  
Nausea And Vomiting ◽  
High Dose ◽  
Saint Louis ◽  
Delayed Phase

e20661 Background: Nausea and vomiting (N/V) are two common side effects during HD IL-2 therapy. They may be severe enough to cause electrolyte imbalances or lead to missed doses, which may compromise response. Our aim was to describe the incidence of N/V during HD IL-2 therapy at our institution. Methods: A retrospective chart review of patients treated with HD IL-2 therapy (720,000 IU/kg per dose intravenously; 14 doses, 2 cycles per course, maximum 2 courses) from January 1999 to June 2011 at Saint Louis University was performed. Patients received scheduled PO ondansetron 24 mg daily and prochlorperazine 10 mg IV or PO every 4 hours as needed per standard protocol. Additional antiemetics were ordered at the clinician’s discretion. Data regarding incidence of N/V and use and type of rescue medication for N/V were recorded. Results: 104 patients were identified (68 melanoma and 36 renal cell carcinoma). Median age was 53.7 years (17.7-77.7 years) and there were 66 men and 38 women. Only 3.8% of patients (4 out of 104) were able to complete HD IL-2 therapy without rescue medication. All patients (n = 100) who needed rescue therapy received prochlorperazine on day 1 of treatment (acute phase) and at least 1 additional day during days 2-6 of each admission (delayed phase). Metoclopramide (n = 23) was the most common supplemental antiemetic ordered followed by promethazine (n = 16), meclizine (n = 5), and palonsetron (n = 3). Conclusions: Almost all patients who underwent HD IL-2 therapy had N/V that necessitated rescue therapy during both the acute phase and the delayed phase. Decreasing the incidence and severity of N/V may increase patients’ quality of life during this demanding regimen. Current protocols are single-institution based, but generally include daily 5HT-3 antagonists and prochlorperazine as needed. Our data suggests that this regimen is inadequate. One challenge to management is that steroids, which are commonly used as adjuncts, are contraindicated during immunotherapy. Additional therapeutic options are still needed. Recently new drug targets, including neurokinin-1 receptor (NK1R) inhibitors, have been approved to treat N/V during chemotherapy. NK1R inhibitors may be of assistance during immunotherapy with HD IL-2 in the future.

scholarly journals Granisetron plus aprepitant versus granisetron in preventing nausea and vomiting during CHOP or R-CHOP regimen in malignant lymphoma: a retrospective study

2019 ◽  
Vol 5 (1) ◽  
Author(s):  
Yoshinori Wakasugi ◽  
Satoshi Noda ◽  
Yoshihiro Ikuno ◽  
Miya Horie ◽  
Katsuyuki Kito ◽  
...  
Keyword(s):  
Malignant Lymphoma ◽  
Rescue Medication ◽  
Rescue Therapy ◽  
Complete Response ◽  
Nausea And Vomiting ◽  
High Dose ◽  
Antiemetic Effect ◽  
Chop Regimen ◽  
Non Hodgkin Lymphoma ◽  
Control Regimen

Abstract Background Cyclophosphamide, doxorubicin, vincristine, and prednisolone (CHOP) regimen includes a high dose of prednisolone (100 mg/body), which exhibits an anticancer and antiemetic effect. However, its optimal use for antiemetic therapy has not been established yet. We assessed the efficacy of granisetron plus aprepitant versus granisetron for CHOP or rituximab-CHOP (R-CHOP) regimen-induced nausea and vomiting in malignant lymphoma. Methods This retrospective and observational clinical study included patients who received CHOP or R-CHOP regimen as initiating chemotherapy between July 2010 and March 2016 (N = 39). Patients were assigned to an aprepitant [aprepitant (125 mg on day 1, 80 mg on days 2–3) plus granisetron (3 mg); n = 15] or control regimen group [granisetron (3 mg); n = 24]. Complete response (CR), defined as no vomiting and no use of rescue therapy during overall phase (0–120 h), was the primary endpoint. Secondary endpoints included the time to first vomiting and using rescue medication and complete protection (CP) defined as no vomiting and no retching and/or no nausea and no rescue therapy. The patient records were investigated, and data were retrospectively analyzed. Results CR rate CP rates did not significantly differ between the groups during the observation period (80.0% versus 83.3%, p = 1.000; and 80.0% versus 79.2%, p = 1.000, respectively). Additionally, the time to first vomiting and using rescue medication in did not significantly differ between the groups (p = 0.909). Conclusions This study suggests that granisetron alone could be one treatment option in the management of CINV in patients with non-Hodgkin lymphoma receiving CHOP or R-CHOP regimen.

scholarly journals Single-dose netupitant/palonosetron versus 3-day aprepitant for preventing chemotherapy-induced nausea and vomiting: a pooled analysis

2021 ◽  
Author(s):  
Rudolph M Navari ◽  
Gary Binder ◽  
Erminio Bonizzoni ◽  
Rebecca Clark-Snow ◽  
Silvia Olivari ◽  
...  
Keyword(s):  
Rescue Medication ◽  
Complete Response ◽  
Pooled Analysis ◽  
Nausea And Vomiting ◽  
Complete Protection ◽  
Efficacy Data ◽  
Delayed Nausea ◽  
Neurokinin 1 ◽  
Type 3 ◽  
Significant Nausea

Aim: In the absence of comparative studies, guidelines consider neurokinin 1 receptor antagonists (RAs) as interchangeable. We evaluated the pooled efficacy from three cisplatin registration trials, each with arms containing netupitant/palonosetron (NEPA), a fixed neurokinin 1 RA (netupitant)/serotonin Type 3 (5-HT3) RA (palonosetron) combination, and an aprepitant (APR) regimen. Materials & methods: Efficacy data were pooled for rates of complete response (CR: no emesis/no rescue medication), complete protection (CR + no significant nausea), total control (CR + no nausea) and no significant nausea during acute (0–24 h), delayed (>24–120 h) and overall (0–120 h) phases post chemotherapy. Results: Among 621 NEPA and 576 APR patients, response rates were similar for the acute phase, and generally favored NEPA during delayed and overall phases. CR rates for NEPA versus APR were 88.4 versus 89.2%, 81.8 versus 76.9% (p < 0.05) and 78.4 versus 75.0% during the acute, delayed and overall phases, respectively. Conclusion: Oral NEPA administered on day 1 was more effective than a 3-day APR regimen in preventing delayed nausea and vomiting associated with cisplatin.

Efficacy of a 1-day 3-drug antiemetic regimen for prevention of acute and delayed nausea and vomiting induced by moderately emetogenic chemotherapy

2007 ◽  
Vol 25 (18_suppl) ◽  
pp. 9111-9111 ◽  
Author(s):  
S. M. Grunberg ◽  
M. Dugan ◽  
H. B. Muss ◽  
M. Wood ◽  
S. Burdette-Radoux ◽  
...  
Keyword(s):  
Adverse Events ◽  
Rescue Medication ◽  
Complete Response ◽  
Emetogenic Chemotherapy ◽  
Nausea And Vomiting ◽  
Moderately Emetogenic Chemotherapy ◽  
Antiemetic Regimen ◽  
Delayed Nausea ◽  
Pre Treatment ◽  
Significant Nausea

9111 Background: Serotonin antagonists, NK-1 antagonists (NKA) and corticosteroids (C) have all shown efficacy against chemotherapy-induced nausea and vomiting. However these agents are commonly used in cumbersome and inconvenient multiple day regimens that can also raise questions of compliance. Palonosetron is a serotonin antagonist with a 40 hour half-life, requiring only one dose for several days of exposure. Single high doses of NKA and C can also be used to simulate drug exposures achieved with a multiple day regimen. We have therefore evaluated a 1-day 3-drug antiemetic regimen for 5 day efficacy against moderately emetogenic chemotherapy. Methods: Patients with solid tumors receiving their first cycle of cyclophosphamide and/or doxorubicin were eligible to receive a single pre-treatment dose of palonosetron 0.25 mg IV/dexamethasone 20 mg PO/aprepitant 285 mg PO. Nausea and vomiting were evaluated over the following 5 days with a patient diary including vomiting episodes, use of rescue medication, and daily nausea visual analogue scale (VAS). Patients were urged to begin rescue medication for nausea, vomiting, or related discomfort. Endpoints included Complete Response (CR) (no emesis or rescue), No Emesis (NE), and No Significant Nausea (NSN) (VAS<25) during the acute period (A) (Day 1), the delayed period (D) (Days 2–5), and the overall period (O) (Days 1–5). Adverse events were recorded and tabulated for at least 14 days. Results: 32 of 40 planned patients have been entered on study. 31 women and 1 man with breast cancer receiving adjuvant chemotherapy with median age 52 years (range 34–74) have been treated and all are evaluable. CR for A/D/O was 78%/59%/50%. However NE for A/D/O was 100%/97%/97%, and NSN for A/D/O was 75%/62%/56%. Only 8 patients had more than one day of Significant Nausea. The most common treatment-related adverse events were fatigue and mild headache. Conclusions: A 1-day 3-drug antiemetic regimen is feasible and effective, and should be tested against a multiple day standard antiemetic regimen. [Table: see text]

The effect of foot reflexology on chemotherapy-induced nausea and vomiting in digestive or lung cancer patients: a randomized controlled trial (Preprint)

2020 ◽  
Author(s):  
Audrey Murat-Ringot ◽  
Pierre Jean Souquet ◽  
Fabien Subtil ◽  
Florent Boutitie ◽  
Marie Preau ◽  
...  
Keyword(s):  
Cancer Patients ◽  
Controlled Trial ◽  
Nausea And Vomiting ◽  
Control Group ◽  
Digestive Cancer ◽  
Complementary Medicines ◽  
Antiemetic Drugs ◽  
Platinum Based Chemotherapy ◽  
Significant Difference ◽  
Delayed Nausea

BACKGROUND Cancer is a chronic disease with an incident worldwide had been 24.5 million and 9.6 million deaths in 2017. Lung and colorectal cancer are the most common cancer for both sexes and according to national and international recommendations platinum-based chemotherapy is the reference adjuvant treatment. This chemotherapy can be moderately to highly emetogenic. Despite antiemetic therapy, chemotherapy-induced nausea and vomiting may persist. Moreover, cancer patient are increasingly interested in alternative and complementary medicines and express the desire that non-pharmacological treatments be used in hospitals. Among alternative and complementary medicines, foot reflexology decreases significantly the severity of chemotherapy-induced nausea and vomiting in breast cancer patients. OBJECTIVE The primary objective of the present study was to assess the benefits of foot reflexology as a complement to conventional treatments on severity of acute chemotherapy-induced nausea and vomiting in digestive or lung cancer patients. The secondary objectives assessed were the frequency and severity of delayed chemotherapy-induced nausea and vomiting, quality of life, anxiety, and self-esteem. METHODS The present study was conducted between April 2018 and April 2020 in French University Hospital. This is an open-label randomized controlled trial. Participants are randomized into two groups: 40 to interventional group (conventional care with foot reflexology) and 40 to control group (conventional care without foot reflexology). Foot reflexology sessions (30 minutes) are performed on an outpatient or inpatient. Eligible participants are patients with a lung or digestive cancer with indication for platinum-based chemotherapy. RESULTS The severity of acute nausea and vomiting was assessed with a visual analogue scale during the second cycle of chemotherapy. A significant increase of at least 2 points was observed for control group (20.6%, P = 0.01). Across all cycle, the foot reflexology group showed a trend towards less frequent delayed nausea (P=0.28), a significantly less frequent consumption of antiemetic drugs (P=0.04), and no significant difference for vomiting (P=0.99); there was a trend towards a perception of stronger severity for delayed nausea in the control group (P=0.39). According to quality of life and anxiety, there was no significant difference between the interventional group and the control group (P=0.32 and P=0.53 respectively). CONCLUSIONS In conclusion, the present study results indicated that foot reflexology decreased significantly the severity of acute nausea and consumption of antiemetic drugs in lung and digestive cancer patients. No side effects from foot reflexology have been noted. In order to better respond to a desire of patients for non-pharmacological treatments and CAMs to be used in hospitals to improve their care, the results of this study showed that foot reflexology seems to be a promising complement to conventional antiemetic drugs. To assess the performance of this intervention in routine practice, a larger study with several health care centers would be relevant with a cluster RCT. CLINICALTRIAL The present study registered with clinicaltrials.gov: NCT03508180 (28/06/2018) INTERNATIONAL REGISTERED REPORT RR2-10.2196/17232

scholarly journals Chemotherapy-induced nausea and vomiting (CINV) with carboplatin plus pemetrexed or carboplatin plus paclitaxel in patients with lung cancer: a propensity score-matched analysis

BMC Cancer ◽  
2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Toshinobu Hayashi ◽  
Mototsugu Shimokawa ◽  
Koichi Matsuo ◽  
Hirotoshi Iihara ◽  
Kei Kawada ◽  
...  
Keyword(s):  
Risk Factors ◽  
Lung Cancer ◽  
Propensity Score ◽  
Nausea And Vomiting ◽  
Lung Cancer Patients ◽  
Pooled Data ◽  
Female Sex ◽  
Antiemetic Prophylaxis ◽  
Delayed Nausea ◽  
Independent Risk Factors

Abstract Background Patients with lung cancer who are treated with carboplatin-based chemotherapy regimens often experience chemotherapy-induced nausea and vomiting (CINV). However, knowledge on the effect of regimen and cofactors on the risk of CINV is limited. This study aimed to analyze and compare the incidence of CINV between lung cancer patients undergoing carboplatin plus pemetrexed (CBDCA+PEM) and those undergoing carboplatin plus paclitaxel (CBDCA+PTX) chemotherapy. Methods Pooled data of 240 patients from two prospective observational studies were compared using propensity score matching. Separate multivariate logistic regression analyses were used to identify risk factors for nausea and vomiting following chemotherapy. Results Delayed nausea was significantly more common in patients treated with CBDCA+PEM than in those treated with CBDCA+PTX (51.1% vs. 36.2%, P = 0.04), but the incidence of vomiting did not significantly differ between the two groups (23.4% vs. 14.9%, P = 0.14). The occurrence of CINV peaked on day 4 in the CBDCA+PTX group and on day 5 in the CBDCA+PEM group. Multivariate analysis showed that female sex, younger age, and CBDCA+PEM regimen were independent risk factors for delayed nausea, while female sex was an independent risk factor for delayed vomiting. Conclusions The CBDCA + PEM regimen has a higher risk of causing delayed nausea than the CBDCA + PTX regimen, and aggressive antiemetic prophylaxis should be offered to patients treated with CBDCA + PEM.

A randomised, placebo-controlled 24-week study evaluating adjunctive brexpiprazole in patients with major depressive disorder

2018 ◽  
Vol 31 (1) ◽  
pp. 27-35 ◽  
Author(s):  
Michael Bauer ◽  
Nanco Hefting ◽  
Annika Lindsten ◽  
Mette Krog Josiassen ◽  
Mary Hobart
Keyword(s):  
Major Depressive Disorder ◽  
Depressive Disorder ◽  
Treatment Period ◽  
Study Design ◽  
Primary Endpoint ◽  
Inadequate Response ◽  
Madrs Total Score ◽  
Open Label ◽  
Major Depressive ◽  
Full Remission

AbstractObjectiveTo evaluate brexpiprazole adjunctive to antidepressant therapies (ADTs) as maintenance treatment in patients with major depressive disorder with inadequate response to ADT, utilising a novel study design.MethodsThe study comprised an 8-week prospective treatment period with open-label ADT with double-blind placebo treatment and a 24-week randomised treatment period. Investigators and patients were blinded to treatment periods, randomisation criteria, and timing of randomisation. Patients with early response to open-label ADT were withdrawn at Week 6. Patients fulfilling criteria for inadequate response were randomised to ADT+brexpiprazole 1–3 mg/day, or ADT+placebo. The primary endpoint was full remission: Montgomery–Åsberg Depression Rating Scale (MADRS) total score ≤10 and ≥50% decrease from randomisation (i.e. baseline) in MADRS total score for at least 8 consecutive weeks.ResultsThe primary efficacy analysis failed to show a statistically significant difference between the proportions of patients on ADT+brexpiprazole (21.4%) and ADT+placebo (24.9%) achieving full remission; odds ratio: 0.83; p=0.2641. The secondary endpoint of change from baseline to Week 6 in MADRS total score showed no difference between ADT+brexpiprazole and ADT+placebo (−0.4; p=0.3259). The most frequent treatment-emergent adverse event (TEAE) in patients receiving ADT+brexpiprazole was weight increased (9.5% vs. 5.0% in ADT+placebo). The incidence of TEAEs leading to withdrawal in the randomised treatment period was 6.3% in the ADT+brexpiprazole group and 3.4% in the ADT+placebo group.ConclusionAdjunctive brexpiprazole did not differentiate from ADT+placebo on the primary endpoint of full remission. A number of design elements in this previously untried study design may have contributed to the study result. Brexpiprazole was well tolerated.

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