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-Åsberg 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.
AIM: This study aims to determine the rate of depression among caregivers of person with depression and its psychosocial correlates, which include stigma, perceived social support, religious commitment and the severity of the patient's symptoms.
METHODS: A cross-sectional study was conducted among 165 patients diagnosed with MDD using the Mini-International Neuropsychiatric Interview (M.I.N.I.) together with their caregivers. Apart from gathering social demographic data, patients were administered the 16-item Quick Inventory of Depressive Symptomatology-Self-Rated Version (QIDS-SR 16), whereas the caregivers were required to answer Patient Health Questionnaire-9 (PHQ-9), Multidimensional Scale of Perceived Social Support (MSPSS), Duke University Religion Index (DUREL) and Depression Stigma Scale (DSS). Those who scored ⩾5 on PHQ-9 were further assessed with interviewer-rated M.I.N.I. to diagnose the presence of depression.
RESULTS: A total of 47 (28.5%) caregivers were found to have depressive symptoms. Out of that total, 13 (7.9%) were diagnosed to have MDD using M.I.N.I. From univariate analysis, factors associated with depression in caregivers were the severity of symptoms in patients ( p
METHOD: Data collected for an individual participant data meta-analysis of Patient Health Questionnaire-9 (PHQ-9) diagnostic accuracy were analysed and binomial generalised linear mixed models were fit.
RESULTS: A total of 17 158 participants (2287 with major depression) from 57 primary studies were analysed. Among fully structured interviews, odds of major depression were higher for the MINI compared with the Composite International Diagnostic Interview (CIDI) (odds ratio (OR) = 2.10; 95% CI = 1.15-3.87). Compared with semi-structured interviews, fully structured interviews (MINI excluded) were non-significantly more likely to classify participants with low-level depressive symptoms (PHQ-9 scores ≤6) as having major depression (OR = 3.13; 95% CI = 0.98-10.00), similarly likely for moderate-level symptoms (PHQ-9 scores 7-15) (OR = 0.96; 95% CI = 0.56-1.66) and significantly less likely for high-level symptoms (PHQ-9 scores ≥16) (OR = 0.50; 95% CI = 0.26-0.97).
CONCLUSIONS: The MINI may identify more people as depressed than the CIDI, and semi-structured and fully structured interviews may not be interchangeable methods, but these results should be replicated.Declaration of interestDrs Jetté and Patten declare that they received a grant, outside the submitted work, from the Hotchkiss Brain Institute, which was jointly funded by the Institute and Pfizer. Pfizer was the original sponsor of the development of the PHQ-9, which is now in the public domain. Dr Chan is a steering committee member or consultant of Astra Zeneca, Bayer, Lilly, MSD and Pfizer. She has received sponsorships and honorarium for giving lectures and providing consultancy and her affiliated institution has received research grants from these companies. Dr Hegerl declares that within the past 3 years, he was an advisory board member for Lundbeck, Servier and Otsuka Pharma; a consultant for Bayer Pharma; and a speaker for Medice Arzneimittel, Novartis, and Roche Pharma, all outside the submitted work. Dr Inagaki declares that he has received grants from Novartis Pharma, lecture fees from Pfizer, Mochida, Shionogi, Sumitomo Dainippon Pharma, Daiichi-Sankyo, Meiji Seika and Takeda, and royalties from Nippon Hyoron Sha, Nanzando, Seiwa Shoten, Igaku-shoin and Technomics, all outside of the submitted work. Dr Yamada reports personal fees from Meiji Seika Pharma Co., Ltd., MSD K.K., Asahi Kasei Pharma Corporation, Seishin Shobo, Seiwa Shoten Co., Ltd., Igaku-shoin Ltd., Chugai Igakusha and Sentan Igakusha, all outside the submitted work. All other authors declare no competing interests. No funder had any role in the design and conduct of the study; collection, management, analysis and interpretation of the data; preparation, review or approval of the manuscript; and decision to submit the manuscript for publication.
DESIGN: A 2 (Culture; Malay, British) × 2 (Mood; depressed, control) cross-sectional design using a card sort task and self-report measures was used.
METHODS: Malay individuals with MDD or no history of MDD completed the life-structure card-sorting task, which provided a novel method for investigating organizational structure of the life narrative. These data were compared to previously collected data in which British individuals with MDD or without MDD had completed the same task within the same experimental protocol.
RESULTS: Pan-culturally those with MDD had greater negativity (i.e., used more negative attributes), negative redundancy (i.e., used the same negative attributes repeatedly across life chapters) and negative emodiversity (i.e., had greater variety and relative abundance of negative attributes), and reduced positive redundancy (i.e., used the same positive attributes repeatedly across chapters) in their structuring relative to controls. While the British MDD group had greater compartmentalization (i.e., the negative and positive attributes were clustered separately across different chapters) than British controls, the Malay MDD group had lower levels of compartmentalization than Malay controls.
CONCLUSIONS: The findings suggest culture may shape aspects of the autobiographical life structure in MDD.
PRACTITIONER POINTS: The majority of the literature investigating depression pertains to individuals from European Western cultures, despite recognition that depression ranks as one of the most debilitating diseases worldwide. This raises questions as to whether current depression models and interventions can be applied universally or whether they are limited to European Western groups. The current study found that pan-culturally those with MDD had similar structuring of their life story relative to controls. However, there were some cultural differences that need to be considered (e.g., Malay individuals provided less detailed, less elaborate and less emotionally diverse life stories and while the British MDD group had greater compartmentalization than British controls, the Malay MDD group had lower levels of compartmentalization than Malay controls). Limitations of the study included group differences in gender and mood at the time of testing. Cultural differences in the number of attributes used may have influenced findings. Only the Malay group completed the individualism-collectivism measure.
METHODS: Using the Short Form of Depression, Anxiety and Stress Scale (DASS21) questionnaire, we aimed (1) to measure the psychological states of hemodialysis (HD) or peritoneal dialysis (PD) subjects from 15 sites, (2) to compare DASS21 scores between HD and PD, and (3) to identify the associated demographic and medical factors of better psychological states.
RESULTS: A total of 1,332 were eligible for analysis. Stress (48%) recorded the highest negative emotional states, followed by depression (37%) and anxiety (20%). By multivariate analysis, normal body mass index weight status, religion and absence of coronary artery disease were associated with lower score for depression, anxiety and stress, respectively. Tertiary education was associated with the lowest score in depression and anxiety, whereas HD had a lower score in stress than PD. A younger age was associated with worse DASS21 score of anxiety and stress.
CONCLUSIONS: Obesity, religion and coronary artery disease were significantly associated with all 3 symptoms of depression, anxiety and stress. Older age has a protective effect on anxiety and stress. Further study is needed to evaluate the relationship between these significant factors and each psychological state.
METHOD: A descriptive cross-sectional study was conducted with a convenience sample of 482 Iranian cancer patients. Participants completed demographic and health, death depression, and religious coping surveys.
RESULTS: After controlling for demographic and health characteristics, positive and negative religious coping behaviors were significantly related to the experience of death depression. There was an interaction effect between negative religious coping and extent of disease with significant positive relationships to the experience of death depression.
CONCLUSIONS: Negative religious coping was found to be more closely associated with death depression in patients with earlier stage disease than those with advanced stages of cancer in this sample of patients with cancer from Iran. Findings support assessing patients for use of religious coping strategies. Muslim patients who are religiously alienated and have existential anguish may be vulnerable and need heightened support following diagnosis and during treatment of early stage cancer.
METHOD: In this retrospective cohort study on data from the Psychiatric Case Register Middle Netherlands linked to the death register of Statistics Netherlands, the risk of cancer death among patients with schizophrenia (N = 4,590), bipolar disorder (N = 2,077), depression (N = 15,130) and their matched controls (N = 87,405) was analyzed using a competing risk model.
RESULTS: Compared to controls, higher hazards of cancer death were found in patients with schizophrenia (HR = 1.61, 95 % CI 1.26-2.06), bipolar disorder (HR = 1.20, 95 % CI 0.81-1.79) and depression (HR = 1.26, 95 % CI 1.10-1.44). However, the HRs of death due to suicide and other death causes were more elevated. Consequently, among those who died, the 12-year cumulative risk of cancer death was significantly lower.
CONCLUSIONS: Our analysis shows that, compared to the general population, psychiatric patients are at higher risk of dying from cancer, provided that they survive the much more elevated risks of suicide and other death causes.