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Allan H Young - One of the best experts on this subject based on the ideXlab platform.

  • esketamine nasal spray plus oral antidepressant in patients with treatment resistant Depression Assessment of long term safety in a phase 3 open label study sustain 2
    The Journal of Clinical Psychiatry, 2020
    Co-Authors: Ewa Wajs, Ella J Daly, Rosanne Lane, Randall L Morrison, Leah Aluisio, Allan H Young, Gerard Sanacora, Richard Holder, Joyce E George, Siegfried Kasper
    Abstract:

    Objective To evaluate long-term safety and efficacy of esketamine nasal spray plus a new oral antidepressant (OAD) in patients with treatment-resistant Depression (TRD). Methods This phase 3, open-label, multicenter, long-term (up to 1 year) study was conducted between October 2015 and October 2017. Patients (≥ 18 years) with TRD (DSM-5 diagnosis of major depressive disorder and nonresponse to ≥ 2 OAD treatments) were enrolled directly or transferred from a short-term study (patients aged ≥ 65 years). Esketamine nasal spray (28-mg, 56-mg, or 84-mg) plus new OAD was administered twice a week in a 4-week induction (IND) phase and weekly or every-other-week for patients who were responders and entered a 48-week optimization/maintenance (OP/MAINT) phase. Results Of 802 enrolled patients, 86.2% were direct-entry and 13.8% were transferred-entry; 580 (74.5%) of 779 patients who entered the IND phase completed the phase, and 150 (24.9%) of 603 who entered the OP/MAINT phase completed the phase. Common treatment-emergent adverse events (TEAEs) were dizziness (32.9%), dissociation (27.6%), nausea (25.1%), and headache (24.9%). Seventy-six patients (9.5%) discontinued esketamine due to TEAEs. Fifty-five patients (6.9%) experienced serious TEAEs. Most TEAEs occurred on dosing days, were mild or moderate in severity, and resolved on the same day. Two deaths were reported; neither was considered related to esketamine. Cognitive performance generally either improved or remained stable postbaseline. There was no case of interstitial cystitis or respiratory Depression. Treatment-emergent dissociative symptoms were transient and generally resolved within 1.5 hours postdose. Montgomery-Asberg Depression Rating Scale total score decreased during the IND phase, and this reduction persisted during the OP/MAINT phase (mean [SD] change from baseline of respective phase to endpoint: IND, -16.4 [8.76]; OP/MAINT, 0.3 [8.12]). Conclusions Long-term esketamine nasal spray plus new OAD therapy had a manageable safety profile, and improvements in Depression appeared to be sustained in patients with TRD. Trial registration ClinicalTrials.gov identifier: NCT02497287.

  • esketamine nasal spray plus oral antidepressant in patients with treatment resistant Depression Assessment of long term safety in a phase 3 open label study sustain 2
    The Journal of Clinical Psychiatry, 2020
    Co-Authors: Ewa Wajs, Rosanne Lane, Randall L Morrison, Leah Aluisio, Ella Daly, Gerard Sanacora, Richard Holder, Joyce E George, Pilar Lim, Allan H Young
    Abstract:

    Objective To evaluate long-term safety and efficacy of esketamine nasal spray plus a new oral antidepressant (OAD) in patients with treatment-resistant Depression (TRD). Methods This phase 3, open-label, multicenter, long-term (up to 1 year) study was conducted between October 2015 and October 2017. Patients (≥ 18 years) with TRD (DSM-5 diagnosis of major depressive disorder and nonresponse to ≥ 2 OAD treatments) were enrolled directly or transferred from a short-term study (patients aged ≥ 65 years). Esketamine nasal spray (28-mg, 56-mg, or 84-mg) plus new OAD was administered twice a week in a 4-week induction (IND) phase and weekly or every-other-week for patients who were responders and entered a 48-week optimization/maintenance (OP/MAINT) phase. Results Of 802 enrolled patients, 86.2% were direct-entry and 13.8% were transferred-entry; 580 (74.5%) of 779 patients who entered the IND phase completed the phase, and 150 (24.9%) of 603 who entered the OP/MAINT phase completed the phase. Common treatment-emergent adverse events (TEAEs) were dizziness (32.9%), dissociation (27.6%), nausea (25.1%), and headache (24.9%). Seventy-six patients (9.5%) discontinued esketamine due to TEAEs. Fifty-five patients (6.9%) experienced serious TEAEs. Most TEAEs occurred on dosing days, were mild or moderate in severity, and resolved on the same day. Two deaths were reported; neither was considered related to esketamine. Cognitive performance generally either improved or remained stable postbaseline. There was no case of interstitial cystitis or respiratory Depression. Treatment-emergent dissociative symptoms were transient and generally resolved within 1.5 hours postdose. Montgomery-Asberg Depression Rating Scale total score decreased during the IND phase, and this reduction persisted during the OP/MAINT phase (mean [SD] change from baseline of respective phase to endpoint: IND, -16.4 [8.76]; OP/MAINT, 0.3 [8.12]). Conclusions Long-term esketamine nasal spray plus new OAD therapy had a manageable safety profile, and improvements in Depression appeared to be sustained in patients with TRD. Trial registration ClinicalTrials.gov identifier: NCT02497287.

Ewa Wajs - One of the best experts on this subject based on the ideXlab platform.

  • esketamine nasal spray plus oral antidepressant in patients with treatment resistant Depression Assessment of long term safety in a phase 3 open label study sustain 2
    The Journal of Clinical Psychiatry, 2020
    Co-Authors: Ewa Wajs, Ella J Daly, Rosanne Lane, Randall L Morrison, Leah Aluisio, Allan H Young, Gerard Sanacora, Richard Holder, Joyce E George, Siegfried Kasper
    Abstract:

    Objective To evaluate long-term safety and efficacy of esketamine nasal spray plus a new oral antidepressant (OAD) in patients with treatment-resistant Depression (TRD). Methods This phase 3, open-label, multicenter, long-term (up to 1 year) study was conducted between October 2015 and October 2017. Patients (≥ 18 years) with TRD (DSM-5 diagnosis of major depressive disorder and nonresponse to ≥ 2 OAD treatments) were enrolled directly or transferred from a short-term study (patients aged ≥ 65 years). Esketamine nasal spray (28-mg, 56-mg, or 84-mg) plus new OAD was administered twice a week in a 4-week induction (IND) phase and weekly or every-other-week for patients who were responders and entered a 48-week optimization/maintenance (OP/MAINT) phase. Results Of 802 enrolled patients, 86.2% were direct-entry and 13.8% were transferred-entry; 580 (74.5%) of 779 patients who entered the IND phase completed the phase, and 150 (24.9%) of 603 who entered the OP/MAINT phase completed the phase. Common treatment-emergent adverse events (TEAEs) were dizziness (32.9%), dissociation (27.6%), nausea (25.1%), and headache (24.9%). Seventy-six patients (9.5%) discontinued esketamine due to TEAEs. Fifty-five patients (6.9%) experienced serious TEAEs. Most TEAEs occurred on dosing days, were mild or moderate in severity, and resolved on the same day. Two deaths were reported; neither was considered related to esketamine. Cognitive performance generally either improved or remained stable postbaseline. There was no case of interstitial cystitis or respiratory Depression. Treatment-emergent dissociative symptoms were transient and generally resolved within 1.5 hours postdose. Montgomery-Asberg Depression Rating Scale total score decreased during the IND phase, and this reduction persisted during the OP/MAINT phase (mean [SD] change from baseline of respective phase to endpoint: IND, -16.4 [8.76]; OP/MAINT, 0.3 [8.12]). Conclusions Long-term esketamine nasal spray plus new OAD therapy had a manageable safety profile, and improvements in Depression appeared to be sustained in patients with TRD. Trial registration ClinicalTrials.gov identifier: NCT02497287.

  • esketamine nasal spray plus oral antidepressant in patients with treatment resistant Depression Assessment of long term safety in a phase 3 open label study sustain 2
    The Journal of Clinical Psychiatry, 2020
    Co-Authors: Ewa Wajs, Rosanne Lane, Randall L Morrison, Leah Aluisio, Ella Daly, Gerard Sanacora, Richard Holder, Joyce E George, Pilar Lim, Allan H Young
    Abstract:

    Objective To evaluate long-term safety and efficacy of esketamine nasal spray plus a new oral antidepressant (OAD) in patients with treatment-resistant Depression (TRD). Methods This phase 3, open-label, multicenter, long-term (up to 1 year) study was conducted between October 2015 and October 2017. Patients (≥ 18 years) with TRD (DSM-5 diagnosis of major depressive disorder and nonresponse to ≥ 2 OAD treatments) were enrolled directly or transferred from a short-term study (patients aged ≥ 65 years). Esketamine nasal spray (28-mg, 56-mg, or 84-mg) plus new OAD was administered twice a week in a 4-week induction (IND) phase and weekly or every-other-week for patients who were responders and entered a 48-week optimization/maintenance (OP/MAINT) phase. Results Of 802 enrolled patients, 86.2% were direct-entry and 13.8% were transferred-entry; 580 (74.5%) of 779 patients who entered the IND phase completed the phase, and 150 (24.9%) of 603 who entered the OP/MAINT phase completed the phase. Common treatment-emergent adverse events (TEAEs) were dizziness (32.9%), dissociation (27.6%), nausea (25.1%), and headache (24.9%). Seventy-six patients (9.5%) discontinued esketamine due to TEAEs. Fifty-five patients (6.9%) experienced serious TEAEs. Most TEAEs occurred on dosing days, were mild or moderate in severity, and resolved on the same day. Two deaths were reported; neither was considered related to esketamine. Cognitive performance generally either improved or remained stable postbaseline. There was no case of interstitial cystitis or respiratory Depression. Treatment-emergent dissociative symptoms were transient and generally resolved within 1.5 hours postdose. Montgomery-Asberg Depression Rating Scale total score decreased during the IND phase, and this reduction persisted during the OP/MAINT phase (mean [SD] change from baseline of respective phase to endpoint: IND, -16.4 [8.76]; OP/MAINT, 0.3 [8.12]). Conclusions Long-term esketamine nasal spray plus new OAD therapy had a manageable safety profile, and improvements in Depression appeared to be sustained in patients with TRD. Trial registration ClinicalTrials.gov identifier: NCT02497287.

Mauro Ceccanti - One of the best experts on this subject based on the ideXlab platform.

  • gamma hydroxybutyric acid ghb in the treatment of alcohol withdrawal syndrome a randomized comparative study versus benzodiazepine
    Alcoholism: Clinical and Experimental Research, 1999
    Co-Authors: Giovanni Addolorato, G Balducci, Esmeralda Capristo, Maria Luisa Attilia, Franco Taggi, G Gasbarrini, Mauro Ceccanti
    Abstract:

    Background: Benzodiazepine has been shown to be one of the most effective class of drugs in the management of alcohol withdrawal syndrome (AWS). Gamma-hydroxybutyric acid (GHB) has recently been introduced in the treatment of alcohol problems, including AWS. At present there are no comparative studies between benzodiazepines and GHB in AWS treatment. The aim of the present randomized, controlled, single-blind study was to evaluate the efficacy and safety of GHB compared with diazepam in the treatment of AWS. Methods: Sixty alcoholics affected by AWS were enrolled in the study. Diazepam (0.5–0.75 mg/kg body weight for 6 days, tapering the dose 25% daily until day 10) was administered orally to 30 patients (25 males, 5 females; mean age 44.3 ± 10.9 years); GHB (50 mg/kg body weight for 10 days) was administered orally to 30 patients (26 males, 4 females; mean age 41.7 ± 10.4 years). The Clinical Institute Withdrawal Assessment for Alcohol-revised scale (CIWA-Ar) was used to evaluate the AWS physical symptoms. The State Anxiety Inventory test for current anxiety Assessment and the Zung self-rating Depression Scale for current Depression Assessment were performed. Results: Eight patients (26.6%) in the diazepam group and 4 patients (13.3%) in the GHB group dropped out. Both treatments were effective in reducing AWS. No significant difference was found between the groups in CIWA-Ar total score at baseline and at the different times of observation. Considering the CIWA-Ar subscore and Zung scale, a significant reduction of anxiety on day 4 (p < 0.02), agitation on day 5 (p < 0.02) and time of recovery of Depression on day 5 (p < 0.02) was observed in the GHB group with respect to the diazepam group. Drowsiness and vertigo developed after initial drug administration in the GHB (19.2%) and diazepam (36.4%) groups and quickly resolved in both groups. Conclusions: GHB is as effective in the management of AWS as benzodiazepine and it seems to be quicker in reducing anxiety, agitation, and Depression. Both drugs are safe and well-tolerated in AWS management.

  • gamma hydroxybutyric acid ghb in the treatment of alcohol withdrawal syndrome a randomized comparative study versus benzodiazepine
    Alcoholism: Clinical and Experimental Research, 1999
    Co-Authors: Giovanni Addolorato, G Balducci, Esmeralda Capristo, Maria Luisa Attilia, Franco Taggi, G Gasbarrini, Mauro Ceccanti
    Abstract:

    Background: Benzodiazepine has been shown to be one of the most effective class of drugs in the management of alcohol withdrawal syndrome (AWS). Gamma-hydroxybutyric acid (GHB) has recently been introduced in the treatment of alcohol problems, including AWS. At present there are no comparative studies between benzodiazepines and GHB in AWS treatment. The aim of the present randomized, controlled, single-blind study was to evaluate the efficacy and safety of GHB compared with diazepam in the treatment of AWS. Methods: Sixty alcoholics affected by AWS were enrolled in the study. Diazepam (0.5–0.75 mg/kg body weight for 6 days, tapering the dose 25% daily until day 10) was administered orally to 30 patients (25 males, 5 females; mean age 44.3 ± 10.9 years); GHB (50 mg/kg body weight for 10 days) was administered orally to 30 patients (26 males, 4 females; mean age 41.7 ± 10.4 years). The Clinical Institute Withdrawal Assessment for Alcohol-revised scale (CIWA-Ar) was used to evaluate the AWS physical symptoms. The State Anxiety Inventory test for current anxiety Assessment and the Zung self-rating Depression Scale for current Depression Assessment were performed. Results: Eight patients (26.6%) in the diazepam group and 4 patients (13.3%) in the GHB group dropped out. Both treatments were effective in reducing AWS. No significant difference was found between the groups in CIWA-Ar total score at baseline and at the different times of observation. Considering the CIWA-Ar subscore and Zung scale, a significant reduction of anxiety on day 4 (p < 0.02), agitation on day 5 (p < 0.02) and time of recovery of Depression on day 5 (p < 0.02) was observed in the GHB group with respect to the diazepam group. Drowsiness and vertigo developed after initial drug administration in the GHB (19.2%) and diazepam (36.4%) groups and quickly resolved in both groups. Conclusions: GHB is as effective in the management of AWS as benzodiazepine and it seems to be quicker in reducing anxiety, agitation, and Depression. Both drugs are safe and well-tolerated in AWS management.

Siegfried Kasper - One of the best experts on this subject based on the ideXlab platform.

  • esketamine nasal spray plus oral antidepressant in patients with treatment resistant Depression Assessment of long term safety in a phase 3 open label study sustain 2
    The Journal of Clinical Psychiatry, 2020
    Co-Authors: Ewa Wajs, Ella J Daly, Rosanne Lane, Randall L Morrison, Leah Aluisio, Allan H Young, Gerard Sanacora, Richard Holder, Joyce E George, Siegfried Kasper
    Abstract:

    Objective To evaluate long-term safety and efficacy of esketamine nasal spray plus a new oral antidepressant (OAD) in patients with treatment-resistant Depression (TRD). Methods This phase 3, open-label, multicenter, long-term (up to 1 year) study was conducted between October 2015 and October 2017. Patients (≥ 18 years) with TRD (DSM-5 diagnosis of major depressive disorder and nonresponse to ≥ 2 OAD treatments) were enrolled directly or transferred from a short-term study (patients aged ≥ 65 years). Esketamine nasal spray (28-mg, 56-mg, or 84-mg) plus new OAD was administered twice a week in a 4-week induction (IND) phase and weekly or every-other-week for patients who were responders and entered a 48-week optimization/maintenance (OP/MAINT) phase. Results Of 802 enrolled patients, 86.2% were direct-entry and 13.8% were transferred-entry; 580 (74.5%) of 779 patients who entered the IND phase completed the phase, and 150 (24.9%) of 603 who entered the OP/MAINT phase completed the phase. Common treatment-emergent adverse events (TEAEs) were dizziness (32.9%), dissociation (27.6%), nausea (25.1%), and headache (24.9%). Seventy-six patients (9.5%) discontinued esketamine due to TEAEs. Fifty-five patients (6.9%) experienced serious TEAEs. Most TEAEs occurred on dosing days, were mild or moderate in severity, and resolved on the same day. Two deaths were reported; neither was considered related to esketamine. Cognitive performance generally either improved or remained stable postbaseline. There was no case of interstitial cystitis or respiratory Depression. Treatment-emergent dissociative symptoms were transient and generally resolved within 1.5 hours postdose. Montgomery-Asberg Depression Rating Scale total score decreased during the IND phase, and this reduction persisted during the OP/MAINT phase (mean [SD] change from baseline of respective phase to endpoint: IND, -16.4 [8.76]; OP/MAINT, 0.3 [8.12]). Conclusions Long-term esketamine nasal spray plus new OAD therapy had a manageable safety profile, and improvements in Depression appeared to be sustained in patients with TRD. Trial registration ClinicalTrials.gov identifier: NCT02497287.

Rosanne Lane - One of the best experts on this subject based on the ideXlab platform.

  • esketamine nasal spray plus oral antidepressant in patients with treatment resistant Depression Assessment of long term safety in a phase 3 open label study sustain 2
    The Journal of Clinical Psychiatry, 2020
    Co-Authors: Ewa Wajs, Ella J Daly, Rosanne Lane, Randall L Morrison, Leah Aluisio, Allan H Young, Gerard Sanacora, Richard Holder, Joyce E George, Siegfried Kasper
    Abstract:

    Objective To evaluate long-term safety and efficacy of esketamine nasal spray plus a new oral antidepressant (OAD) in patients with treatment-resistant Depression (TRD). Methods This phase 3, open-label, multicenter, long-term (up to 1 year) study was conducted between October 2015 and October 2017. Patients (≥ 18 years) with TRD (DSM-5 diagnosis of major depressive disorder and nonresponse to ≥ 2 OAD treatments) were enrolled directly or transferred from a short-term study (patients aged ≥ 65 years). Esketamine nasal spray (28-mg, 56-mg, or 84-mg) plus new OAD was administered twice a week in a 4-week induction (IND) phase and weekly or every-other-week for patients who were responders and entered a 48-week optimization/maintenance (OP/MAINT) phase. Results Of 802 enrolled patients, 86.2% were direct-entry and 13.8% were transferred-entry; 580 (74.5%) of 779 patients who entered the IND phase completed the phase, and 150 (24.9%) of 603 who entered the OP/MAINT phase completed the phase. Common treatment-emergent adverse events (TEAEs) were dizziness (32.9%), dissociation (27.6%), nausea (25.1%), and headache (24.9%). Seventy-six patients (9.5%) discontinued esketamine due to TEAEs. Fifty-five patients (6.9%) experienced serious TEAEs. Most TEAEs occurred on dosing days, were mild or moderate in severity, and resolved on the same day. Two deaths were reported; neither was considered related to esketamine. Cognitive performance generally either improved or remained stable postbaseline. There was no case of interstitial cystitis or respiratory Depression. Treatment-emergent dissociative symptoms were transient and generally resolved within 1.5 hours postdose. Montgomery-Asberg Depression Rating Scale total score decreased during the IND phase, and this reduction persisted during the OP/MAINT phase (mean [SD] change from baseline of respective phase to endpoint: IND, -16.4 [8.76]; OP/MAINT, 0.3 [8.12]). Conclusions Long-term esketamine nasal spray plus new OAD therapy had a manageable safety profile, and improvements in Depression appeared to be sustained in patients with TRD. Trial registration ClinicalTrials.gov identifier: NCT02497287.

  • esketamine nasal spray plus oral antidepressant in patients with treatment resistant Depression Assessment of long term safety in a phase 3 open label study sustain 2
    The Journal of Clinical Psychiatry, 2020
    Co-Authors: Ewa Wajs, Rosanne Lane, Randall L Morrison, Leah Aluisio, Ella Daly, Gerard Sanacora, Richard Holder, Joyce E George, Pilar Lim, Allan H Young
    Abstract:

    Objective To evaluate long-term safety and efficacy of esketamine nasal spray plus a new oral antidepressant (OAD) in patients with treatment-resistant Depression (TRD). Methods This phase 3, open-label, multicenter, long-term (up to 1 year) study was conducted between October 2015 and October 2017. Patients (≥ 18 years) with TRD (DSM-5 diagnosis of major depressive disorder and nonresponse to ≥ 2 OAD treatments) were enrolled directly or transferred from a short-term study (patients aged ≥ 65 years). Esketamine nasal spray (28-mg, 56-mg, or 84-mg) plus new OAD was administered twice a week in a 4-week induction (IND) phase and weekly or every-other-week for patients who were responders and entered a 48-week optimization/maintenance (OP/MAINT) phase. Results Of 802 enrolled patients, 86.2% were direct-entry and 13.8% were transferred-entry; 580 (74.5%) of 779 patients who entered the IND phase completed the phase, and 150 (24.9%) of 603 who entered the OP/MAINT phase completed the phase. Common treatment-emergent adverse events (TEAEs) were dizziness (32.9%), dissociation (27.6%), nausea (25.1%), and headache (24.9%). Seventy-six patients (9.5%) discontinued esketamine due to TEAEs. Fifty-five patients (6.9%) experienced serious TEAEs. Most TEAEs occurred on dosing days, were mild or moderate in severity, and resolved on the same day. Two deaths were reported; neither was considered related to esketamine. Cognitive performance generally either improved or remained stable postbaseline. There was no case of interstitial cystitis or respiratory Depression. Treatment-emergent dissociative symptoms were transient and generally resolved within 1.5 hours postdose. Montgomery-Asberg Depression Rating Scale total score decreased during the IND phase, and this reduction persisted during the OP/MAINT phase (mean [SD] change from baseline of respective phase to endpoint: IND, -16.4 [8.76]; OP/MAINT, 0.3 [8.12]). Conclusions Long-term esketamine nasal spray plus new OAD therapy had a manageable safety profile, and improvements in Depression appeared to be sustained in patients with TRD. Trial registration ClinicalTrials.gov identifier: NCT02497287.