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JAMA Psychiatry Jun 2023Prenatal depression is prevalent with negative consequences for both the mother and developing fetus. Brief, effective, and safe interventions to reduce depression... (Randomized Controlled Trial)
Randomized Controlled Trial
IMPORTANCE
Prenatal depression is prevalent with negative consequences for both the mother and developing fetus. Brief, effective, and safe interventions to reduce depression during pregnancy are needed.
OBJECTIVE
To evaluate depression improvement (symptoms and diagnosis) among pregnant individuals from diverse backgrounds randomized to brief interpersonal psychotherapy (IPT) vs enhanced usual care (EUC).
DESIGN, SETTING, AND PARTICIPANTS
A prospective, evaluator-blinded, randomized clinical trial, the Care Project, was conducted among adult pregnant individuals who reported elevated symptoms during routine obstetric care depression screening in general practice in obstetrics and gynecology (OB/GYN) clinics. Participants were recruited between July 2017 and August 2021. Repeated measures follow-up occurred across pregnancy from baseline (mean [SD], 16.7 [4.2] gestational weeks) through term. Pregnant participants were randomized to IPT or EUC and included in intent-to-treat analyses.
INTERVENTIONS
Treatment comprised an engagement session and 8 active sessions of brief IPT (MOMCare) during pregnancy. EUC included engagement and maternity support services.
MAIN OUTCOMES AND MEASURES
Two depression symptom scales, the 20-item Symptom Checklist and the Edinburgh Postnatal Depression Scale, were assessed at baseline and repeatedly across pregnancy. Structured Clinical Interview for DSM-5 ascertained major depressive disorder (MDD) at baseline and the end of gestation.
RESULTS
Of 234 participants, 115 were allocated to IPT (mean [SD] age, 29.7 [5.9] years; 57 [49.6%] enrolled in Medicaid; 42 [36.5%] had current MDD; 106 [92.2%] received intervention) and 119 to EUC (mean [SD] age, 30.1 [5.9] years; 62 [52.1%] enrolled in Medicaid; 44 [37%] had MDD). The 20-item Symptom Checklist scores improved from baseline over gestation for IPT but not EUC (d = 0.57; 95% CI, 0.22-0.91; mean [SD] change for IPT vs EUC: 26.7 [1.14] to 13.6 [1.40] vs 27.1 [1.12] to 23.5 [1.34]). IPT participants more rapidly improved on Edinburgh Postnatal Depression Scale compared with EUC (d = 0.40; 95% CI, 0.06-0.74; mean [SD] change for IPT vs EUC: 11.4 [0.38] to 5.4 [0.57] vs 11.5 [0.37] to 7.6 [0.55]). MDD rate by end of gestation had decreased significantly for IPT participants (7 [6.1%]) vs EUC (31 [26.1%]) (odds ratio, 4.99; 95% CI, 2.08-11.97).
CONCLUSIONS AND RELEVANCE
In this study, brief IPT significantly reduced prenatal depression symptoms and MDD compared with EUC among pregnant individuals from diverse racial, ethnic, and socioeconomic backgrounds recruited from primary OB/GYN clinics. As a safe, effective intervention to relieve depression during pregnancy, brief IPT may positively affect mothers' mental health and the developing fetus.
TRIAL REGISTRATION
ClinicalTrials.gov Identifier: NCT03011801.
Topics: Adult; Humans; Female; Pregnancy; Depression; Depressive Disorder, Major; Treatment Outcome; Prospective Studies; Psychotherapy, Brief
PubMed: 37074698
DOI: 10.1001/jamapsychiatry.2023.0702 -
Nutrients Aug 2021Recent animal studies have supported that PS128 (PS128) can reduce the severity of anxiety and depression. However, previous studies did not focus on the sleep quality... (Randomized Controlled Trial)
Randomized Controlled Trial
Recent animal studies have supported that PS128 (PS128) can reduce the severity of anxiety and depression. However, previous studies did not focus on the sleep quality and mood of humans. This study determines whether PS128 reduces the severity of anxiety and depressive symptoms, regulates autonomic nervous system function, and improves sleep quality. Forty participants between 20 and 40 years of age with self-reported insomnia were randomly assigned to two groups, a PS128 group and a placebo group, in a double-blind trial. Participants took two capsules of either PS128 or a placebo after dinner for 30 days. Study measures included subjective depressive symptoms, anxiety and sleep questionnaires, and miniature-polysomnography recordings at baseline and on the 15th and 30th days of taking capsules. Overall, all outcomes were comparable between the two groups at baseline and within the 30-day period, yet some differences were still found. Compared to the control group, the PS128 group showed significant decreases in Beck Depression Inventory-II scores, fatigue levels, brainwave activity, and awakenings during the deep sleep stage. Their improved depressive symptoms were related to changes in brain waves and sleep maintenance. These findings suggest that daily administration of PS128 may lead to a decrease in depressive symptoms, fatigue level, cortical excitation, and an improvement in sleep quality during the deep sleep stage. Daily consumption of PS128 as a dietary supplement may improve the depressive symptoms and sleep quality of insomniacs, although further investigation is warranted.
Topics: Adult; Affect; Anxiety; Anxiety Disorders; Brain Waves; Depression; Depressive Disorder; Double-Blind Method; Fatigue; Female; Gastrointestinal Microbiome; Humans; Lactobacillus plantarum; Male; Pilot Projects; Polysomnography; Probiotics; Psychological Tests; Self Report; Sleep; Sleep Initiation and Maintenance Disorders; Sleep Stages
PubMed: 34444980
DOI: 10.3390/nu13082820 -
Cell Reports. Medicine Jun 2023It has been 15 years since repetitive transcranial magnetic stimulation (rTMS) targeting the dorsolateral prefrontal cortex (DLPFC) was approved by the FDA for clinical... (Randomized Controlled Trial)
Randomized Controlled Trial
It has been 15 years since repetitive transcranial magnetic stimulation (rTMS) targeting the dorsolateral prefrontal cortex (DLPFC) was approved by the FDA for clinical depression treatment. Yet, the underlying mechanisms for rTMS-induced depression relief are not fully elucidated. This study analyzes TMS-electroencephalogram (EEG) data from 64 healthy control (HC) subjects and 53 patients with major depressive disorder (MDD) before and after rTMS treatment. Prior to treatment, patients with MDD have lower activity in the DLPFC, the hippocampus (HPC), the orbitofrontal cortex (OFC), and DLPFC-OFC connectivity compared with HCs. Following active rTMS treatment, patients with MDD show a significant increase in the DLPFC, HPC, and OFC. Notably, the increase in HPC activity is specifically associated with amelioration of depressive symptoms but not anxiety or sleep quality. The orbitofrontal-hippocampal pathway plays a crucial role in mediating depression relief following rTMS treatment. These findings suggest potential alternative targets for brain stimulation therapy against depression (chictr.org.cn: ChiCTR2100052007).
Topics: Humans; Depressive Disorder, Major; Depression; Electroencephalography; Prefrontal Cortex; Transcranial Magnetic Stimulation; Hippocampus
PubMed: 37263267
DOI: 10.1016/j.xcrm.2023.101060 -
Depression and Anxiety Oct 2019Actigraphy may provide a more valid assessment of sleep, circadian rhythm (CR), and physical activity (PA) than self-reported questionnaires, but has not been used...
BACKGROUND
Actigraphy may provide a more valid assessment of sleep, circadian rhythm (CR), and physical activity (PA) than self-reported questionnaires, but has not been used widely to study the association with depression/anxiety and their clinical characteristics.
METHODS
Fourteen-day actigraphy data of 359 participants with current (n = 93), remitted (n = 176), or no (n = 90) composite international diagnostic interview depression/anxiety diagnoses were obtained from the Netherlands Study of Depression and Anxiety. Objective estimates included sleep duration (SD), sleep efficiency, relative amplitude (RA) between day-time and night-time activity, mid sleep on free days (MSF), gross motor activity (GMA), and moderate-to-vigorous PA (MVPA). Self-reported measures included insomnia rating scale, SD, MSF, metabolic equivalent total, and MVPA.
RESULTS
Compared to controls, individuals with current depression/anxiety had a significantly different objective, but not self-reported, PA and CR: lower GMA (23.83 vs. 27.4 milli-gravity/day, p = .022), lower MVPA (35.32 vs. 47.64 min/day, p = .023), lower RA (0.82 vs. 0.83, p = .033). In contrast, self-reported, but not objective, sleep differed between people with current depression/anxiety compared to those without current disorders; people with current depression/anxiety reported both shorter and longer SD and more insomnia. More depressive/anxiety symptoms and number of depressive/anxiety diagnoses were associated with larger disturbances of the actigraphy measures.
CONCLUSION
Actigraphy provides ecologically valid information on sleep, CR, and PA that enhances data from self-reported questionnaires. As those with more severe or comorbid forms showed the lowest PA and most CR disruptions, the potential for adjunctive behavioral and chronotherapy interventions should be explored, as well as the potential of actigraphy to monitor treatment response to such interventions.
Topics: Actigraphy; Anxiety; Anxiety Disorders; Circadian Rhythm; Comorbidity; Depression; Depressive Disorder; Exercise; Female; Humans; Male; Middle Aged; Netherlands; Self Report; Sleep; Sleep Initiation and Maintenance Disorders; Surveys and Questionnaires; Time Factors
PubMed: 31348850
DOI: 10.1002/da.22949 -
JAMA Psychiatry Oct 2020To prevent suicide deaths, acute care settings need tools to ensure individuals at risk of suicide access mental health care and remain safe until they do so. (Meta-Analysis)
Meta-Analysis
Association of Suicide Prevention Interventions With Subsequent Suicide Attempts, Linkage to Follow-up Care, and Depression Symptoms for Acute Care Settings: A Systematic Review and Meta-analysis.
IMPORTANCE
To prevent suicide deaths, acute care settings need tools to ensure individuals at risk of suicide access mental health care and remain safe until they do so.
OBJECTIVE
To examine the association of brief acute care suicide prevention interventions with patients' subsequent suicide attempts, linkage to follow-up care, and depression symptoms at follow-up.
DATA SOURCES
Ovid MEDLINE, Scopus, CINAHL, PsychINFO, Embase, and references of included studies using concepts of suicide, prevention, and clinical trial to identify relevant articles published January 2000 to May 2019.
STUDY SELECTION
Studies describing clinical trials of single-encounter suicide prevention interventions were included. Two reviewers independently reviewed all articles to determine eligibility for study inclusion.
DATA EXTRACTION AND SYNTHESIS
Two reviewers independently abstracted data according to PRISMA guidelines and assessed studies' risk of bias using the Cochrane Risk of Bias tool. Data were pooled for each outcome using random-effects models. Small study effects including publication bias were assessed using Peter and Egger regression tests.
MAIN OUTCOMES AND MEASURES
Three primary outcomes were examined: subsequent suicide attempts, linkage to follow-up care, and depression symptoms at follow-up. Suicide attempts and linkage to follow-up care were measured using validated patient self-report measures and medical record review; odds ratios and Hedges g standardized mean differences were pooled to estimate effect sizes. Depression symptoms were measured 2 to 3 months after the encounter using validated self-report measures, and pooled Hedges g standardized mean differences were used to estimate effect sizes.
RESULTS
A total of 14 studies, representing outcomes for 4270 patients, were included. Pooled-effect estimates showed that brief suicide prevention interventions were associated with reduced subsequent suicide attempts (pooled odds ratio, 0.69; 95% CI, 0.53-0.89), increased linkage to follow-up (pooled odds ratio, 3.04; 95% CI, 1.79-5.17) but were not associated with reduced depression symptoms (Hedges g = 0.28 [95% CI, -0.02 to 0.59).
CONCLUSIONS AND RELEVANCE
In this meta-analysis, breif suicide prevention interventions were associated with reduced subsequent suicide attempts. Suicide prevention interventions delivered in a single in-person encounter may be effective at reducing subsequent suicide attempts and ensuring that patients engage in follow-up mental health care.
Topics: Aftercare; Clinical Trials as Topic; Depression; Depressive Disorder; Follow-Up Studies; Humans; Odds Ratio; Psychotherapy, Brief; Recurrence; Risk Assessment; Suicide; Suicide, Attempted; Suicide Prevention
PubMed: 32584936
DOI: 10.1001/jamapsychiatry.2020.1586 -
Translational Psychiatry Nov 2020Repetitive transcranial magnetic stimulation (rTMS) has gained growing interest for the treatment of major depression (MDD) and treatment-resistant depression (TRD).... (Meta-Analysis)
Meta-Analysis Review
Repetitive transcranial magnetic stimulation (rTMS) has gained growing interest for the treatment of major depression (MDD) and treatment-resistant depression (TRD). Most knowledge on rTMS comes from human studies as preclinical application has been problematic. However, recent optimization of rTMS in animal models has laid the foundations for improved translational studies. Preclinical studies have the potential to help identify optimal stimulation protocols and shed light on new neurobiological-based rationales for rTMS use. To assess existing evidence regarding rTMS effects on depressive-like symptoms in rodent models, we conducted a comprehensive literature search in accordance with PRISMA guidelines (PROSPERO registration number: CRD42019157549). In addition, we conducted a meta-analysis to determine rTMS efficacy, performing subgroup analyses to examine the impact of different experimental models and neuromodulation parameters. Assessment of the depressive-like phenotype was quite homogeneous whilst rTMS parameters among the 23 included studies varied considerably. Most studies used a stress-induced model. Overall, results show a largely beneficial effect of active rTMS compared to sham stimulation, as reflected in the statistically significant recovery of both helplessness (SDM 1.34 [1.02;1.66]) and anhedonic (SDM 1.87 [1.02;2.72]) profiles. Improvement of the depressive-like phenotype was obtained in all included models and independently of rTMS frequency. Nonetheless, these results have limited predictive value for TRD patients as only antidepressant-sensitive models were used. Extending rTMS studies to other MDD models, corresponding to distinct endophenotypes, and to TRD models is therefore crucial to test rTMS efficacy and to develop cost-effective protocols, with the potential of yielding faster clinical responses in MDD and TRD.
Topics: Antidepressive Agents; Depression; Depressive Disorder, Major; Depressive Disorder, Treatment-Resistant; Humans; Transcranial Magnetic Stimulation; Treatment Outcome
PubMed: 33173042
DOI: 10.1038/s41398-020-01055-2 -
Laeknabladid Sep 2022The hallucinogen psilocybin is a potential novel treatment for treatment-resistant depression (TRD). Our goal is to review current knowledge on psilocybin and its...
The hallucinogen psilocybin is a potential novel treatment for treatment-resistant depression (TRD). Our goal is to review current knowledge on psilocybin and its efficacy in TRD. Literature searches were done on PubMed, Web of Science and Google Scholar, references reviewed in identified articles and other articles found on the website of COMPASS Pathways. Psilocybin treatment consists usually of a single oral administration of 25 mg of psilocybin along with psychological support for 5-8 hours during the ensuing hallucinogenic trip. Common side-effects include headache, nausea, fatigue and insomnia. A systematic review has demonstrated significant antidepressant efficacy in certain groups and a double-blind randomized study found antidepressant efficacy of psilocybin comparable to the SSRI escitalopram. In the phase 2 study of COMPASS Pathways, the psilocybin-COMP360 treatment led to a rapid response and remission as early as three weeks following the treatment for around one third of participants. Recent studies have shown that psilocybin significantly decreases the severity of depressive symptoms and is generally well tolerated. Further research will reveal whether it will be granted a license to treat treatment-resistant depression in the near future. There remains an urgent need for novel treatments for those who do not respond to current antidepressant therapies.
Topics: Antidepressive Agents; Depression; Depressive Disorder, Treatment-Resistant; Hallucinogens; Humans; Psilocybin; Randomized Controlled Trials as Topic
PubMed: 36040772
DOI: 10.17992/lbl.2022.09.706 -
Neuropsychopharmacology : Official... Jan 2021Treatment-resistant depression (TRD) is prevalent and associated with a substantial psychosocial burden and mortality. There are few prior studies of interventions for... (Randomized Controlled Trial)
Randomized Controlled Trial
Treatment-resistant depression (TRD) is prevalent and associated with a substantial psychosocial burden and mortality. There are few prior studies of interventions for TRD in adolescents. This was the largest study to date examining the feasibility, safety, and efficacy of 10-Hz transcranial magnetic stimulation (TMS) for adolescents with TRD. Adolescents with TRD (aged 12-21 years) were enrolled in a randomized, sham-controlled trial of TMS across 13 sites. Treatment resistance was defined as an antidepressant treatment record level of 1 to 4 in a current episode of depression. Intention-to-treat patients (n = 103) included those randomly assigned to active NeuroStar TMS monotherapy (n = 48) or sham TMS (n = 55) for 30 daily treatments over 6 weeks. The primary outcome measure was change in the Hamilton Depression Rating Scale (HAM-D-24) score. After 6 weeks of blinded treatment, improvement in the least-squares mean (SE) HAM-D-24 scores were similar between the active (-11.1 [2.03]) and sham groups (-10.6 [2.00]; P = 0.8; difference [95% CI], - 0.5 [-4.2 to 3.3]). Response rates were 41.7% in the active group and 36.4% in the sham group (P = 0.6). Remission rates were 29.2% in the active group and 29.0% in the sham group (P = 0.95). There were no new tolerability or safety signals in adolescents. Although TMS treatment produced a clinically meaningful change in depressive symptom severity, this did not differ from sham treatment. Future studies should focus on strategies to reduce the placebo response and examine the optimal dosing of TMS for adolescents with TRD.
Topics: Adolescent; Depression; Depressive Disorder, Major; Depressive Disorder, Treatment-Resistant; Double-Blind Method; Humans; Prefrontal Cortex; Transcranial Magnetic Stimulation; Treatment Outcome
PubMed: 32919400
DOI: 10.1038/s41386-020-00829-y -
JAMA Psychiatry Nov 2022Treatment-resistant depression (TRD) is common in older adults. Bilateral repetitive transcranial magnetic stimulation (rTMS) of the dorsolateral prefrontal cortex for... (Randomized Controlled Trial)
Randomized Controlled Trial
Effectiveness of Standard Sequential Bilateral Repetitive Transcranial Magnetic Stimulation vs Bilateral Theta Burst Stimulation in Older Adults With Depression: The FOUR-D Randomized Noninferiority Clinical Trial.
IMPORTANCE
Treatment-resistant depression (TRD) is common in older adults. Bilateral repetitive transcranial magnetic stimulation (rTMS) of the dorsolateral prefrontal cortex for 48 minutes has demonstrated efficacy in TRD. Theta burst stimulation (TBS), a newer form of rTMS, can also be delivered bilaterally using left intermittent TBS and right continuous TBS for only 4 minutes.
OBJECTIVE
To establish the effectiveness and tolerability of TBS compared with standard rTMS in older adults with TRD.
DESIGN, SETTING, AND PARTICIPANTS
In this randomized noninferiority trial with open treatment and blinded assessors, recruitment occurred between December 2016 and March 2020. The trial was conducted at the Centre for Addiction and Mental Health in Toronto, Ontario, Canada and included outpatients 60 years and older with a diagnosis of depression, moderate severity, and nonresponse to 1 or more antidepressant trial of adequate dosage and duration or intolerance of 2 or more trials.
INTERVENTIONS
Participants were randomized to receive a course of 4 to 6 weeks of either bilateral standard rTMS or TBS.
MAIN OUTCOMES AND MEASURES
The primary outcome measure was change in Montgomery-Åsberg Depression Rating Scale; secondary outcome measures included the 17-item Hamilton Rating Scale for Depression, Quick Inventory of Depressive Symptomatology (16-item) (self-report), and dropout rates. A noninferiority margin of 2.75 points was used for the primary outcome. All participants who attained the primary completion point of 4 weeks were analyzed.
RESULTS
A total of 87 participants (mean [SD] age, 67.1 [6.7] years; 47 [54.0%] female) were randomized to standard bilateral rTMS and 85 (mean [SD] age, 66.3 [5.3] years; 45 [52.9%] female) to TBS, of whom 85 (98%) and 79 (93%) were assessed for the primary outcome, respectively, whereas tolerability was assessed in all randomized participants. In the rTMS group, 4 (4.6%) were American Indian, reported other, or preferred not to answer; 5 (5.8%) were Asian; and 78 (89.7%) were White. In the TBS group, 6 (7.1%) were Asian, 2 (2.4%) were Black or reported other, and 77 (90.3%) were White. Mean (SD) Montgomery-Åsberg Depression Rating Scale total scores improved from 25.6 (4.0) to 17.3 (8.9) for rTMS and 25.7 (4.7) to 15.8 (9.1) for TBS (adjusted difference, 1.55; lower 95% CI -0.67), establishing noninferiority for TBS. The all-cause dropout rates were relatively similar between groups (rTMS: 2 of 87 [2.3%]; TBS: 6 of 85 [7.1%]; P = .14; χ2 = 2.2).
CONCLUSIONS AND RELEVANCE
In older adults with TRD, bilateral TBS compared with standard bilateral rTMS achieved noninferior reduction in depression symptoms. Both treatments had low and similar dropout rates. Using TBS rather than rTMS could increase access to treatment several-fold for older adults with TRD.
TRIAL REGISTRATION
ClinicalTrials.gov Identifier: NCT02998580.
Topics: Female; Humans; Aged; Male; Transcranial Magnetic Stimulation; Depression; Depressive Disorder, Major; Prefrontal Cortex; Depressive Disorder, Treatment-Resistant; Ontario; Treatment Outcome
PubMed: 36129719
DOI: 10.1001/jamapsychiatry.2022.2862 -
Ugeskrift For Laeger Sep 2021Psychotic depression is a severe and underdiagnosed psychiatric disorder, which differs from non-psychotic depression biologically, clinically, therapeutically and... (Review)
Review
Psychotic depression is a severe and underdiagnosed psychiatric disorder, which differs from non-psychotic depression biologically, clinically, therapeutically and prognostically. Due to the differences in treatment and the higher risk of suicidal behaviour, the correct diagnosis is crucial. Patients with psychotic depression have an increased risk of a new episode and readmission. Treatment of psychotic depression takes place during hospitalisation and is either ECT or a combination of antidepressant treatment and antipsychotics, which is summarised in this review.
Topics: Bipolar Disorder; Depression; Depressive Disorder, Major; Humans; Mental Disorders; Psychotic Disorders
PubMed: 34596517
DOI: No ID Found