US FDA 505(b)(2) NDA clinical, CMC and regulatory strategy concepts to expedite drug development.

The 505(b)(2) NDA pathway can reduce drug development costs and accelerate the time to market by leveraging existing public data using clinical bridging and regulatory strategies. Whether or not a drug qualifies for the 505(b)(2) pathway depends on the active ingredient, drug formulation, clinical indication and other factors. Clinical programs can be streamlined and accelerated, and confer unique marketing benefits, such as exclusivity, depending on the regulatory strategy and product.

Psychological Distress, Anxiety, Depression, and Associated Factors Among Nigerian Healthcare Workers During COVID-19 Pandemic: A Cross-Sectional Study.

We determined the prevalence of psychological distress, and the associations between sociodemographic factors, anxiety, depression, COVID-19-related experiences, and psychological distress, among nurses and doctors in Nigeria. The study was a cross-sectional descriptive study, conducted over a month (1st of July-31st of July 2021) among 434 Health Care Workers (HCWs) [225 (51.8%) nurses and 209 (48.

Developing an mHealth Intervention to Reduce COVID-19-Associated Psychological Distress Among Health Care Workers in Nigeria: Protocol for a Design and Feasibility Study.

Background: Globally, COVID-19-related psychological distress is seriously eroding health care workers' mental health and well-being, especially in low-income countries like Nigeria. The use of mobile health (mHealth) interventions is now increasingly recognized as an innovative approach that may improve mental health and well-being. This project aims to develop an mHealth psychological intervention (mPsyI) to reduce COVID-19-related psychological distress among health care workers in Nigeria.

Associated Psychological Factors of Viral Load among Self-Isolating Nigerian COVID-19 Patients.

Background: Corona virus disease 2019 (COVID-19) is a pandemic that has affected millions of people worldwide. The aim of this study was to explore the psychological factors of viral load among COVID-19 patients who were on self-isolation in Nigeria.

Methods: This is a cross-sectional study involving five hundred and nine self-isolating COVID-19 patients in Osogbo, Nigeria.

Associations between psychological wellbeing, depression, general anxiety, perceived social support, tooth brushing frequency and oral ulcers among adults resident in Nigeria during the first wave of the COVID-19 pandemic.

Introduction: The aims of this study were to determine the associations between psychological wellbeing, and the frequency of tooth brushing and presence of oral ulcers during the COVID-19 pandemic; and to identify the mediating roles of psychological distress (general anxiety and depression) and perceived social support in the paths of observed associations.

Methods: This cross-sectional study recruited 996 adults in Nigeria between June and August 2020. Data collected through an online survey included outcome variables (decreased frequency of tooth brushing and presence of oral ulcers), explanatory variable (psychological wellbeing), mediators (general anxiety symptoms, depression symptoms and perceived social support) and confounders (age, sex at birth, educational and employment status).

The Adaption of the Work Environment Survey for Public Health Nurses.

The study presents the iterative process of the adaption and psychometric properties evaluation of the Work Environment/Support/Encouragement section of the Revised Casey-Fink Nurse Retention Survey (2009) to measure the work environment of public health nurses (PHNs). This secondary data analysis was based on data collected from a convenience sample of 596 PHNs across North Carolina that were originally used to study PHNs workforce retention. Classical test theory analyses were used to evaluate scale reliability and identify potential problematic items that were further examined from a substantive perspective using content validity survey.

Childhood Trauma Questionnaire-Short Form (CTQ-SF): Dimensionality, validity, reliability and gender invariance among Nigerian adolescents.

Background: Childhood abuse and neglect have been associated with long term psychological consequences. There is no valid, reliable and gender invariant scale available for the evaluation of childhood abuse and neglect among Nigerian adolescents.

Objective: To evaluate the Childhood Trauma Questionnaire-Short Form (CTQ-SF) in terms of its factor structure, validity, reliability, and gender measurement invariance among Nigerian adolescents.

Obsessive Compulsive Inventory - Child Version (OCI-CV): Confirmatory factor analysis, reliability, validity and correlates among Nigerian adolescents.

Background: Obsessive compulsive symptoms (OCS) have not been studied among Nigerian adolescents, despite studies in developed countries reporting that almost 90% of affected adolescents do not receive any treatment. The availability of a psychometrically valid and reliable instrument will serve as an initial step towards the diagnosis and subsequent treatment of Nigerian adolescent obsessive compulsive disorder (OCD).

Aims: The aim of this study was to examine the psychometric characteristics as well as correlates of the Obsessive Compulsive Inventory - Child Version (OCI-CV) in a non-clinical sample of Nigerian adolescents.

The Brief 10-Item Community Assessment of Psychic Experiences-Positive Scale (Brief CAPE-P10): Initial psychometric properties, gender measurement invariance and mean differences among Nigerian adolescents.

Aim: The aim of this study was to evaluate the Community Assessment of Psychic Experiences-Positive Scale (CAPE-P) for its psychometric properties in terms of its reliability and validity, in addition to its factor structure and gender measurement invariance among Nigerian adolescents (n = 1336, M = 15.15).

Methods: The sample consisted of 606 (45.

Alternative Models Examination and Gender Measurement Invariance of the 12-item General Health Questionnaire among Nigerian Adolescents.

Objective: The objective of this study was to examine the factor structures of the a priori alternative models of the 12-items General Health Questionnaire (GHQ-12), its psychometric characteristics and gender measurement invariance in a sample of non-clinical Nigerian adolescents (n=1326; Mage=15.16).

Methods: The sample consisted of 606 (45.

Economic Cost of Asthma and Psychiatric Morbidity in Nigerian Patients with Asthma.

Background: Asthma is known to constitute a huge economic burden to its sufferers and their carers. There is a dearth of studies documenting this burden among asthmatics in Nigeria.

Objective: This study assessed the relationship between economic cost and psychiatric morbidity among stable Nigerian patients with asthma.

Economic Cost of Schizophrenia in a Nigerian Teaching Hospital.

Objective: This study evaluated the economic cost of schizophrenia in Nigerian patients and identified factors that influence cost.

Methods: A total of 100 participants with schizophrenia were assessed using the modified economic cost questionnaire, the mini-international neuropsychiatric interview, the positive and negative syndrome scale, the Liverpool University Neuroleptic side-effect rating scale, and the global assessment of functioning scale. Associations between sociodemographic characteristics, illness-related variables and direct, indirect, and total costs of schizophrenia were assessed.

The relationship between obsessive compulsive symptoms and quality of life in Nigerian patients with schizophrenia.

Background: Obsessive compulsive symptoms (OCS) are relatively common in schizophrenia. Their presence and severity can affect the quality of life (QoL) of schizophrenia patients.

Objective: This study aimed to determine the effect of OCS on the subjective QoL of the Nigerian outpatients with schizophrenia.

Sleep Hygiene Index: Psychometric Characteristics and Usefulness as a Screening Tool in a Sample of Nigerian Undergraduate Students.

Study Objectives: The objectives of this study were to investigate the psychometric properties of the Sleep Hygiene Index (SHI) and determine its capacity to screen for poor sleep quality in a nonclinical sample of Nigerian university students.

Methods: A total of 348 students appropriately completed the SHI, the Morningness-Eveningness Questionnaire (MEQ), the Pittsburgh Sleep Quality Index (PSQI), and the Epworth Sleepiness Scale (ESS).

Results: The internal consistency (Cronbach alpha) of the SHI was .

Public Awareness and Attitude Towards Depression: A Community Based Study Among an Adult Population in Ile-Ife South-Western Nigeria.

Depression has become a global health priority due to its associated burden. However, there is dearth of information regarding the public awareness and attitude towards depression in Nigeria. This study aimed to assess the level of public awareness and attitude towards depression in a semi-urban Nigerian community.

Psychometric Properties and Correlates of the Beck Hopelessness Scale in Family Caregivers of Nigerian Patients with Psychiatric Disorders in Southwestern Nigeria.

Objectives: To examine the construct and correlates of hopelessness among family caregivers of Nigerian psychiatric patients.

Materials And Methods: This is a cross-sectional, descriptive study involving 264 family caregiver-patients' dyads recruited from two university teaching hospitals psychiatric clinics in Southwestern Nigeria.

Results: Exploratory factor analysis revealed a two-factor 9-item model of the Beck Hopelessness Scale (BHS) among the family caregivers.

The 10-Item Connor-Davidson Resilience Scale: Factorial Structure, Reliability, Validity, and Correlates Among Student Nurses in Southwestern Nigeria.

Background: The 10-item Connor-Davidson Resilience Scale (CD-RISC) has demonstrated satisfactory psychometric properties as a measure of resilience in all the previous studies conducted in developed countries.

Objective: The objective of this study was to explore the psychometric characteristics of the 10-item CD-RISC among students nurses in southwestern Nigeria.

Design: This descriptive cross-sectional study involved a total of 449 student nurses who completed the 10-item CD-RISC in addition to measures of self-esteem, depression, religiosity, and psychological distress.

Disability assessment as an outcome measure: a comparative study of Nigerian outpatients with schizophrenia and healthy control.

Background And Objective: Schizophrenia is a chronic mental disorder that leads to disability in several aspects of the individual's personal, social, and occupational functioning. This study assesses and compares the level of disability among Nigerian outpatients with schizophrenia and healthy controls (HC).

Methods: A comparative cross-sectional study among 100 schizophrenia outpatients with an ICD-10 diagnosis and 100 HC was conducted over a 4-month period.

Trust in Physician Scale: factor structure, reliability, validity and correlates of trust in a sample of Nigerian psychiatric outpatients.

Background: Trust is essential in the patient-physician relationship and has not been explored among Nigerian psychiatric outpatients.

Objectives: The purpose of this study was to evaluate the psychometric characteristics of the Trust in Physician Scale among a cross-sectional sample of stable Nigerian outpatients receiving treatment for psychiatric disorders.

Methods: A consecutive sample of outpatients attending a Nigerian university teaching hospital psychiatric clinic in South-western Nigeria completed the scale (N=223).