scholarly journals 118 Use of Patient Health Questionnaire to Predict Relapses in Patients with Treatment-resistant Depression Treated With Esketamine + Oral Antidepressant

CNS Spectrums ◽  
2020 ◽  
Vol 25 (2) ◽  
pp. 276-277
Author(s):  
Carol Jamieson ◽  
Nan Li ◽  
Ella Daly ◽  
Adam Janik ◽  
Rosanne Lane ◽  
...  
Keyword(s):  
Depressive Symptoms ◽  
Patient Health Questionnaire ◽  
Controlled Study ◽  
Health Questionnaire ◽  
Treatment Resistant Depression ◽  
Treatment Resistant ◽  
Relapse Risk ◽  
Total Score Range ◽  
Patient Health ◽  
Resistant Depression

Abstract:Objective:To assess the Patient Health Questionnaire (PHQ-9) as a predictor of relapse of depressive symptoms in treatment-resistant depression (TRD).Method:Analysis included maintenance phase data from SUSTAIN-1 (NCT02493868), a randomized, double-blind, active-controlled study in TRD patients that evaluated efficacy of intranasal esketamine (ESK) + oral antidepressant (AD) vs AD + intranasal placebo in delaying relapse of depressive symptoms. A ≥50% reduction in initial symptom score and total score of ≤12 were considered as response and remission, respectively, using the Montgomery-Asberg Depression Rating Scale. PHQ-9 total score (range, 0–27), PHQ-2 total score (0–6), and individual items of the PHQ-9 (0–3) were examined as predictors of relapse. Data were collected every 2 weeks. Association between time-varying PHQ-9 and event of depression relapse was evaluated in Andersen-Gill Cox model.Results:Of 176 stable remitters, 63 had a relapse event (ESK+AD [n=24]; AD+placebo [n=39]). Of 121 stable responders, 50 had a relapse event (ESK+AD [n=16]; AD+placebo [n=34]). Among stable remitters, PHQ-9 total score (HR; 95% CI [1.12; 1.04–1.21]) and PHQ-2 total score (1.58; 1.25–1.99) were associated with relapse risk. PHQ-9 items #1 (loss of pleasure, 2.07; 1.38–3.09), #2 (feeling down, 2.18; 1.51–3.15), #4 (feeling tired, 1.54; 1.13–2.11), and #6 (negative self-view, 2.27; 1.41–3.66) were associated with relapse risk. PHQ-2 total scale yielded the smallest Akaike’s Information Criterion among stable remitters and responders.Conclusion:PHQ-9, PHQ-2 total scores or individual items may be useful for predicting relapse of depressive symptoms among stable TRD patients.Funding Acknowledgements:This study was sponsored by Janssen Research and Development, LLC.

scholarly journals Prolonged ketamine infusion modulates limbic connectivity and induces sustained remission of treatment-resistant depression

2021 ◽  
Author(s):  
Joshua S. Siegel ◽  
Ben J. A. Palanca ◽  
Beau M. Ances ◽  
Evan D. Kharasch ◽  
Julie A. Schweiger ◽  
...  
Keyword(s):  
Depressive Symptoms ◽  
Limbic System ◽  
Anterior Cingulate ◽  
Sustained Remission ◽  
Treatment Resistant Depression ◽  
Treatment Resistant ◽  
Open Label ◽  
Subgenual Anterior Cingulate Cortex ◽  
Post Infusion ◽  
Resistant Depression

AbstractKetamine produces a rapid antidepressant response in over 50% of adults with treatment-resistant depression. A long infusion of ketamine may provide durable remission of depressive symptoms, but the safety, efficacy, and neurobiological correlates are unknown. In this open-label, proof-of-principle study, adults with treatment-resistant depression (N = 23) underwent a 96-h infusion of intravenous ketamine (0.15 mg/kg/h titrated toward 0.6 mg/kg/h). Clonidine was co-administered to reduce psychotomimetic effects. We measured clinical response for 8 weeks post-infusion. Resting-state functional magnetic resonance imaging was used to assess functional connectivity in patients pre- and 2 weeks post-infusion and in matched non-depressed controls (N = 27). We hypothesized that responders to therapy would demonstrate response-dependent connectivity changes while all subjects would show treatment-dependent connectivity changes. Most participants completed infusion (21/23; mean final dose 0.54 mg/kg/h, SD 0.13). The infusion was well tolerated with minimal cognitive and psychotomimetic side effects. Depressive symptoms were markedly reduced (MADRS 29 ± 4 at baseline to 9 ± 8 one day post-infusion), which was sustained at 2 weeks (13 ± 8) and 8 weeks (15 ± 8). Imaging demonstrated a response-dependent decrease in hyperconnectivity of the subgenual anterior cingulate cortex to the default mode network, and a treatment-dependent decrease in hyperconnectivity within the limbic system (hippocampus, amygdala, medial thalamus, nucleus accumbens). In exploratory analyses, connectivity was increased between the limbic system and frontal areas, and smaller right hippocampus volume at baseline predicted larger MADRS change. A single prolonged infusion of ketamine provides a tolerated, rapid, and sustained response in treatment-resistant depression and normalizes depression-related hyperconnectivity in the limbic system and frontal lobe.ClinicalTrials.gov: Treatment Resistant Depression (Pilot), NCT01179009.

scholarly journals Validation and calibration of the patient health questionnaire (PHQ-9) in Argentina

2019 ◽  
Vol 19 (1) ◽  
Author(s):  
María Urtasun ◽  
Federico Manuel Daray ◽  
Germán Leandro Teti ◽  
Fernando Coppolillo ◽  
Gabriela Herlax ◽  
...  
Keyword(s):  
Depressive Symptoms ◽  
Convergent Validity ◽  
Patient Health Questionnaire ◽  
Receiver Operating Curve ◽  
Local Version ◽  
Health Questionnaire ◽  
Good Ability ◽  
Patient Health ◽  
Severity Of Depression ◽  
Degrees Of Severity

Abstract Background The Patient Health Questionnaire-9 (PHQ-9) is a brief tool to assess the presence and severity of depressive symptoms. This study aimed to validate and calibrate the PHQ-9 to determine appropriate cut-off points for different degrees of severity of depression in Argentina. Methods We conducted a cross-sectional study on an intentional sample of adult ambulatory care patients with different degrees of severity of depression. All patients who completed the PHQ-9 were further interviewed by a trained clinician with the Mini International Neuropsychiatric Interview (MINI) and the Beck Depression Inventory-II (BDI-II). Reliability and validity tests, including receiver operating curve analysis, were performed. Results One hundred sixty-nine patients were recruited with a mean age of 47.4 years (SD = 14.8), of whom 102 were females (60.4%). The local PHQ-9 had high internal consistency (Cronbach’s alpha = 0.87) and satisfactory convergent validity with the BDI-II scale [Pearson’s correlation = 0.88 (p < 0.01)]. For the diagnosis of Major Depressive Episode (MDE) according to the MINI, a PHQ-9 ≥ 8 was the optimal cut-off point found (sensitivity 88.2%, specificity 86.6%, PPV 90.91%). The local version of PHQ-9 showed good ability to discriminate among depression severity categories according to the BDI-II scale. The best cut off points were 6–8 for mild cases, 9–14 for moderate and 15 or more for severe depressive symptoms respectively. Conclusions The Argentine version of the PHQ-9 questionnaire has shown acceptable validity and reliability for both screening and severity assessment of depressive symptoms.

scholarly journals The reliability and validity of the Patient Health Questionnaire-9 (PHQ-9) and PHQ-2 in patients with infertility

2019 ◽  
Vol 16 (1) ◽  
Author(s):  
Saman Maroufizadeh ◽  
Reza Omani-Samani ◽  
Amir Almasi-Hashiani ◽  
Payam Amini ◽  
Mahdi Sepidarkish
Keyword(s):  
Depressive Symptoms ◽  
Internal Consistency ◽  
Convergent Validity ◽  
Univariate Analysis ◽  
Reliability And Validity ◽  
Well Being ◽  
Patient Health Questionnaire ◽  
Depression Symptoms ◽  
Health Questionnaire ◽  
Patient Health

Abstract Background Depression in patients with infertility often goes undiagnosed and untreated. The Patient Health Questionnaire-9 (PHQ-9) and its ultra-brief version (i.e. PHQ-2) are widely used measures of depressive symptoms. These scales have not been validated in patients with infertility. The aim of the present study was to examine the reliability and validity of the PHQ-9 and PHQ-2 in patients with infertility. Methods In this cross-sectional study, a total of 539 patients with infertility from a referral infertility clinic in Tehran, Iran completed the PHQ-9, along with other relevant scales: the WHO-five Well-being Index (WHO-5), the Hospital Anxiety and Depression Scale (HADS), and the Generalized Anxiety Disorder-7 (GAD-7). Factor structure and internal consistency of PHQ-9 were examined via confirmatory factor analysis (CFA) and Cronbach’s alpha, respectively. Convergent validity was evaluated by relationship with WHO-5, HADS and GAD-7. Results The mean total PHQ-9 and PHQ-2 scores were 8.47 ± 6.17 and 2.42 ± 1.86, respectively, and using a cut-off value of 10 (for PHQ-9) and 3 (for PHQ-2), the prevalence of depressive symptoms was 38.6 and 43.6%, respectively. The Cronbach’s alphas for PHQ-9 and PHQ-2 were, respectively, 0.851 and 0.767, indicating good internal consistency. The CFA results confirmed the one-factor model of the PHQ-9 (χ2/df = 4.29; CFI = 0.98; RMSEA = 0.078 and SRMR = 0.044). Both PHQ-9 and PHQ-2 showed moderate to strong correlation with the measures of WHO-5, HADS-depression, HADS-anxiety, and the GAD-7, confirming convergent validity. In univariate analysis, female sex, long infertility duration, and unsuccessful treatment were significantly associated with depression symptoms. Conclusion Both PHQ-9 and PHQ-2 are brief and easy to use measures of depressive symptoms with good psychometric properties that appear suitable for routine use in patients with infertility.

scholarly journals Efficacy and safety of fixed doses of intranasal Esketamine as an add-on therapy to Oral antidepressants in Japanese patients with treatment-resistant depression: a phase 2b randomized clinical study

2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Nagahide Takahashi ◽  
Aya Yamada ◽  
Ayako Shiraishi ◽  
Hiroko Shimizu ◽  
Ryosuke Goto ◽  
...  
Keyword(s):  
Nasal Spray ◽  
Japanese Patients ◽  
Controlled Study ◽  
Induction Phase ◽  
Treatment Resistant Depression ◽  
Treatment Resistant ◽  
Madrs Total Score ◽  
Link Type ◽  
Randomized Clinical Study ◽  
Resistant Depression

Abstract Background Esketamine nasal spray (Spravato) in conjunction with oral antidepressants (ADs) is approved in the European Union, United States, and other markets for treatment-resistant depression (TRD). Efficacy, safety, and tolerability of esketamine nasal spray in Japanese patients with TRD needs to be assessed. Methods This Phase 2b, randomized, double-blind (DB), placebo-controlled study was conducted in adult Japanese patients with TRD meeting the Diagnostic and Statistical Manual of Mental Disorders (fifth edition) criteria of major depressive disorder with nonresponse to ≥ 1 but < 5 different ADs in the current episode at screening. Patients were treated with a new oral AD for 6 weeks (prospective lead-in phase); nonresponders were randomized (2:1:1:1) to placebo or esketamine (28-, 56-, or 84-mg) nasal spray along with the continued use of AD for 4 weeks (DB induction phase). Responders (≥50% reduction from baseline in the Montgomery-Asberg Depression Rating Scale [MADRS] total score) from the DB induction phase continued into the 24-week posttreatment phase and patients who relapsed could participate in a 4-week open-label (OL) second induction (flexibly-dosed esketamine). The primary efficacy endpoint, change from baseline in the MADRS total score at Day 28 in the DB induction phase, was based on mixed-effects model using repeated measures pairwise comparisons using a Dunnett adjustment. Results Of the 202 patients randomized in the DB induction phase (esketamine [n = 122] or placebo [n = 80]), the MADRS total scores decreased from baseline to Day 28 of the DB induction phase (− 15.2, − 14.5, − 15.1, and − 15.3 for esketamine 28 mg, 56 mg, 84 mg, and placebo groups, respectively), indicating an improvement in depressive symptoms; however, the difference between the esketamine and placebo groups was not statistically significant. The most common treatment-emergent adverse events during the DB induction phase in the combined esketamine group (incidences ranging from 12.3 to 41.0%) were blood pressure increased, dissociation, dizziness, somnolence, nausea, hypoaesthesia, vertigo, and headache; the incidence of each of these events was > 2-fold higher than the corresponding incidence in the placebo group. Conclusions Efficacy of esketamine plus oral AD in Japanese TRD patients was not established; further investigation is warranted. All esketamine doses were safe and tolerated. Trial registration ClinicalTrials.gov Identifier: NCT02918318. Registered: 28 September 2016.

scholarly journals Direct Participation in and Indirect Exposure to the Occupy Central Movement and Depressive Symptoms: A Longitudinal Study of Hong Kong Adults

2016 ◽  
Vol 184 (9) ◽  
pp. 636-643 ◽  
Author(s):  
Michael Y. Ni ◽  
Tom K. Li ◽  
Herbert Pang ◽  
Brandford H. Y. Chan ◽  
Betty Y. Yuan ◽  
...  
Keyword(s):  
Hong Kong ◽  
Depressive Symptoms ◽  
Major Depression ◽  
Patient Health Questionnaire ◽  
Health Questionnaire ◽  
Personal Involvement ◽  
Patient Health ◽  
Population Mental Health ◽  
History Of ◽  
Occupy Central

Abstract Despite the extensive history of social movements around the world, the evolution of population mental health before, during, and after a social movement remains sparsely documented. We sought to assess over time the prevalence of depressive symptoms during and after the Occupy Central movement in Hong Kong and to examine the associations of direct and indirect exposures to Occupy Central with depressive symptoms. We longitudinally administered interviews to 909 adults who were randomly sampled from the population-representative FAMILY Cohort at 6 time points from March 2009 to March 2015: twice each before, during, and after the Occupy Central protests. The Patient Health Questionnaire-9 was used to assess depressive symptoms and probable major depression (defined as Patient Health Questionnaire-9 score ≥10). The absolute prevalence of probable major depression increased by 7% after Occupy Central, regardless of personal involvement in the protests. Higher levels of depressive symptoms were associated with online and social media exposure to protest-related news (incidence rate ratio (IRR) = 1.28, 95% confidence interval (CI): 1.06, 1.55) and more frequent Facebook use (IRR = 1.38, 95% CI: 1.12, 1.71). Higher levels of intrafamilial sociopolitical conflict was associated with more depressive symptoms (IRR = 1.05, 95% CI: 1.01, 1.09). The Occupy Central protests resulted in substantial and sustained psychological distress in the community.

Baseline Working Memory Predicted Response to Low-Dose Ketamine Infusion in Patients with Treatment-Resistant Depression

2021 ◽  
Author(s):  
Mu-Hong Chen ◽  
Wei-Chen Lin ◽  
Cheng-Ta Li ◽  
Shih-Jen Tsai ◽  
Hui-Ju Wu ◽  
...  
Keyword(s):  
Working Memory ◽  
Depressive Symptoms ◽  
Treatment Response ◽  
Low Dose ◽  
Memory Function ◽  
Treatment Resistant Depression ◽  
Treatment Resistant ◽  
Ketamine Infusion ◽  
Treatment Groups ◽  
Resistant Depression

Abstract Introduction Pretreatment neurocognitive function may predict the treatment response to low-dose ketamine infusion in patients with treatment-resistant depression (TRD). However, the association between working memory function at baseline and the antidepressant efficacy of ketamine infusion remains unclear. Methods A total of 71 patients with TRD were randomized to one of three treatment groups: 0.5 mg/kg ketamine, 0.2 mg/kg ketamine, or normal saline. Depressive symptoms were measured using the 17-item Hamilton Depression Rating Scale (HDRS) at baseline and after treatment. Cognitive function was evaluated using working memory and go-no-go tasks at baseline. Results A generalized linear model with adjustments for demographic characteristics, treatment groups, and total HDRS scores at baseline revealed only a significant effect of working memory function (correct responses and omissions) on the changes in depressive symptoms measured by HDRS at baseline (F=12.862, p<0.05). Correlation analysis further showed a negative relationship (r=0.519, p=0.027) between pretreatment working memory function and changes in HDRS scores in the 0.5 mg/kg ketamine group. Discussion An inverse relationship between pretreatment working memory function and treatment response to ketamine infusion may confirm that low-dose ketamine infusion is beneficial and should be reserved for patients with TRD.

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