scholarly journals A Combined Digital and Biomarker Diagnostic Aid for Mood Disorders (the Delta Trial): Protocol for an Observational Study

10.2196/18453 ◽  
2020 ◽  
Vol 9 (8) ◽  
pp. e18453 ◽  
Author(s):  
Tony Olmert ◽  
Jason D Cooper ◽  
Sung Yeon Sarah Han ◽  
Giles Barton-Owen ◽  
Lynn Farrag ◽  
...  

Background Mood disorders affect hundreds of millions of people worldwide, imposing a substantial medical and economic burden. Existing diagnostic methods for mood disorders often result in a delay until accurate diagnosis, exacerbating the challenges of these disorders. Advances in digital tools for psychiatry and understanding the biological basis of mood disorders offer the potential for novel diagnostic methods that facilitate early and accurate diagnosis of patients. Objective The Delta Trial was launched to develop an algorithm-based diagnostic aid combining symptom data and proteomic biomarkers to reduce the misdiagnosis of bipolar disorder (BD) as a major depressive disorder (MDD) and achieve more accurate and earlier MDD diagnosis. Methods Participants for this ethically approved trial were recruited through the internet, mainly through Facebook advertising. Participants were then screened for eligibility, consented to participate, and completed an adaptive digital questionnaire that was designed and created for the trial on a purpose-built digital platform. A subset of these participants was selected to provide dried blood spot (DBS) samples and undertake a World Health Organization World Mental Health Composite International Diagnostic Interview (CIDI). Inclusion and exclusion criteria were chosen to maximize the safety of a trial population that was both relevant to the trial objectives and generalizable. To provide statistical power and validation sets for the primary and secondary objectives, 840 participants were required to complete the digital questionnaire, submit DBS samples, and undertake a CIDI. Results The Delta Trial is now complete. More than 3200 participants completed the digital questionnaire, 924 of whom also submitted DBS samples and a CIDI, whereas a total of 1780 participants completed a 6-month follow-up questionnaire and 1542 completed a 12-month follow-up questionnaire. The analysis of the trial data is now underway. Conclusions If a diagnostic aid is able to improve the diagnosis of BD and MDD, it may enable earlier treatment for patients with mood disorders. International Registered Report Identifier (IRRID) DERR1-10.2196/18453

2020 ◽  
Author(s):  
Tony Olmert ◽  
Jason D Cooper ◽  
Sung Yeon Sarah Han ◽  
Giles Barton-Owen ◽  
Lynn Farrag ◽  
...  

BACKGROUND Mood disorders affect hundreds of millions of people worldwide, imposing a substantial medical and economic burden. Existing diagnostic methods for mood disorders often result in a delay until accurate diagnosis, exacerbating the challenges of these disorders. Advances in digital tools for psychiatry and understanding the biological basis of mood disorders offer the potential for novel diagnostic methods that facilitate early and accurate diagnosis of patients. OBJECTIVE The Delta Trial was launched to develop an algorithm-based diagnostic aid combining symptom data and proteomic biomarkers to reduce the misdiagnosis of bipolar disorder (BD) as a major depressive disorder (MDD) and achieve more accurate and earlier MDD diagnosis. METHODS Participants for this ethically approved trial were recruited through the internet, mainly through Facebook advertising. Participants were then screened for eligibility, consented to participate, and completed an adaptive digital questionnaire that was designed and created for the trial on a purpose-built digital platform. A subset of these participants was selected to provide dried blood spot (DBS) samples and undertake a World Health Organization World Mental Health Composite International Diagnostic Interview (CIDI). Inclusion and exclusion criteria were chosen to maximize the safety of a trial population that was both relevant to the trial objectives and generalizable. To provide statistical power and validation sets for the primary and secondary objectives, 840 participants were required to complete the digital questionnaire, submit DBS samples, and undertake a CIDI. RESULTS The Delta Trial is now complete. More than 3200 participants completed the digital questionnaire, 924 of whom also submitted DBS samples and a CIDI, whereas a total of 1780 participants completed a 6-month follow-up questionnaire and 1542 completed a 12-month follow-up questionnaire. The analysis of the trial data is now underway. CONCLUSIONS If a diagnostic aid is able to improve the diagnosis of BD and MDD, it may enable earlier treatment for patients with mood disorders. INTERNATIONAL REGISTERED REPORT DERR1-10.2196/18453


2011 ◽  
Vol 41 (9) ◽  
pp. 1897-1906 ◽  
Author(s):  
O. Gureje ◽  
B. Oladeji ◽  
T. Abiona

BackgroundWe present the incidence and risk factors for major depressive disorder (MDD) among community-dwelling elderly Nigerians.MethodA cohort study of persons aged ⩾65 years residing in eight contiguous Yoruba-speaking states in south-west and north-central Nigeria was conducted between November 2003 and December 2007. Of the 2149 baseline sample, 1408 (66%) were successfully followed up after approximately 39 months. Face-to-face in-home assessments were conducted with the World Health Organization (WHO) Composite International Diagnostic Interview, version 3 (CIDI.3) and diagnosis was based on the DSM-IV. Incident MDD was determined in the group with no prior lifetime history of MDD at baseline and who were free of dementia at follow-up (n=892).ResultsDuring the follow-up period, 308 persons had developed incident MDD, representing a rate of 104.3 [95% confidence interval (CI) 93.3–116.6] per 1000 person-years. Compared to males, the age-adjusted hazard for females was 1.63 (95% CI 1.30–2.06). Lifetime or current subsyndromal symptoms of depression at baseline did not increase the risk of incident MDD. Among females, but not males, rural residence and poor social network were risk factors for incident MDD. Physical health status at baseline did not predict new onset of MDD.ConclusionsThe finding of a high incidence of MDD among elderly Nigerians complements earlier reports of a high prevalence of the disorder in this understudied population. Social factors, in particular those relating to social isolation, constitute a risk for incident MDD.


2003 ◽  
Vol 182 (3) ◽  
pp. 205-209 ◽  
Author(s):  
Petros Skapinakis ◽  
Glyn Lewis ◽  
Venetsanos Mavreas

BackgroundUnexplained fatigue has been extensively studied but most of the samples used were from Western countries.AimsTo present international data on the prevalence of unexplained fatigue and fatigue as a presenting complaint in primary care.MethodSecondary analysis of the World Health Organization study of psychological problems in general health care. A total of 5438 primary care attenders from 14 countries were assessed with the Composite International Diagnostic Interview.ResultsThe prevalence of unexplained fatigue of 1-month duration differed across centres, with a range between 2.26 (95% CI 1.17–4.33) and 15.05 (95% CI 10.85–20.49). Subjects from more-developed countries were more likely to report unexplained fatigue but less likely to present with fatigue to physicians compared with subjects from less developed countries.ConclusionsIn less-developed countries fatigue might be an indicator of unmet psychiatric need, but in more-developed countries it is probably a symbol of psychosocial distress.


1998 ◽  
Vol 173 (6) ◽  
pp. 501-507 ◽  
Author(s):  
William W. Eaton ◽  
James C. Anthony ◽  
Alan Romanoski ◽  
Allen Tien ◽  
Joseph Gallo ◽  
...  

BackgroundThe objective is to estimate parameters of the natural history of panic disorder, including its prodrome, incidence, recovery and recurrence.MethodIn 1981 the Baltimore Epidemiologic Catchment Area Study interviewed 3481 individuals probabilistically selected from the household population. During 1993–1996, 1920 of these individuals (73% of survivors) were interviewed again. Baseline and follow-up interviews included the National Institute of Mental Health Diagnostic Interview Schedule. During the follow-up, a subsample was assessed by psychiatrists using the World Health Organization Schedules for Clinical Assessment in Neuropsychiatry (SCAN).ResultsThere were 35 new cases of panic disorder in 24 475 person years of exposure, yielding an annual incidence of 1.43 per 1000 per year. Data from the SCAN assessments suggest the incidence estimate is conservative. Incidence is greater in females and declines with age. About one-third of the new cases arise without agoraphobia, but about half have anxiety of some sort present for many years prior to meeting criteria for diagnosis. People with agoraphobia have less intense onsets but slower recoveries than those without agoraphobia.ConclusionsPanic is heterogeneous in its pattern of onset and recovery. Some of the heterogeneity is associated with the presence of other anxiety over a long period of the life.


2004 ◽  
Vol 34 (2) ◽  
pp. 323-333 ◽  
Author(s):  
N. BRESLAU ◽  
S. P. NOVAK ◽  
R. C. KESSLER

Background. Recent research has demonstrated that smokers are at an elevated risk for psychiatric disorders. This study extends the enquiry by examining: (1) the specificity of the psychiatric sequelae of smoking; and (2) the variability in the likelihood of these sequelae by proximity and intensity of smoking.Method. Data come from the National Comorbidity Survey (NCS), a representative sample of the US population 15–54 years of age. The Smoking Supplement was administered to a representative subset of 4414 respondents. A modified World Health Organization – Composite International Diagnostic Interview was used to measure DSM-III-R disorders. Survival analysis with smoking variables as time-dependent covariates was used to predict the subsequent onset of specific psychiatric disorders.Results. The estimated effects of daily smoking varied across disorders. In the case of mood disorders, daily smoking predicted subsequent onset, with no variation between current versus past smokers or by smoking intensity. In the case of panic disorder and agoraphobia, current but not past smoking predicted subsequent onset; furthermore, the risk of these disorders in past smokers decreased with increasing time since quitting. In the case of substance use disorders, current but not past smoking predicted subsequent onset, with no variation by time since quitting or smoking intensity.Conclusions. The data suggest that smoking cessation programmes would not prevent the onset of mood disorder, as ex-smokers do not differ from current smokers in their risk for these disorders. In comparison, daily smoking might be a causal factor in panic disorder and agoraphobia, conditions that might be preventable by smoking cessation. Additionally, current smoking might serve as a marker for targeting interventions to prevent alcohol and drug disorders.


1991 ◽  
Vol 6 (6) ◽  
pp. 277-285 ◽  
Author(s):  
CB Pull ◽  
HU Wittchen

SummaryThe Composite International Diagnostic Interview (CIDI), the Schedules for Clinical Assessment in Neuropsychiatry (SCAN) and the International Personality Disorder Examination (IPDE) constitute part of a family of instruments which have been designed for the assessment of mental disorders as defined by the explicit diagnostic criteria and algorithms in ICD 10 and DSM III-R. They have been developed at the request of the World Health Organization and the United States Alcohol, Drug Abuse, and Mental Health Administration to foster a common language in the mental health field, to facilitate comparisons of clinical and research findings from different settings, countries and cultures, and to improve the scientific basis of diagnosis and classification in psychiatry. This report describes the background, purpose and essential features of the three instruments.


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