PRADO study

JRCT ID: jRCT1030230621

Registered date:07/02/2024

Basic Information

• Recruitment status: Pending
• Health condition(s) or Problem(s) studied: Generalized Anxiety Disorder
• Date of first enrollment: 26/02/2024
• Target sample size: 400
• Study type: Observational

Outcome(s)

• Primary Outcome: To estimate the prevalence of patients diagnosed with Generalized Anxiety Disorder based on DSM-5 diagnostic criteria, which is confirmed by SCID.

Secondary Outcome

-To evaluate patient health, QoL and functional status related scores using EuroQoL 5-dimension 5 Level (EQ-5D-5L), Quick Inventory of Depressive Symptomatology Self-Report (QIDS-SR), Sheehan Disability Scale (SDISS), GAD-7, Adverse Childhood Experiences(ACE) calculator and K6. Also, Generalized Anxiety Disorder patient severity of illness will be assessed using the Clinical Global Impression Severity Scale (CGI-S).
-To estimate the prevalence of patients with primary diagnosis of Generalized Anxiety Disorder based on the DSM-5 diagnostic criteria, which is confirmed by SCID.
-To estimate the prevalence of patients diagnosed with Generalized Anxiety Disorder by ICD-10 diagnostic category diagnosed prior to this study.
-The percentage of psychiatric disorders diagnosed other than Generalized Anxiety Disorder by SCID.
-The percentage of psychiatric disorders comorbid with Generalized Anxiety Disorder by SCID.
-The percentage of diagnostic agreement with the GAD-7 total score.
-The percentage of diagnostic agreement with the K6 total score.
-To determine the factors (variables: age, gender, family history, treatment history, medical history,
disease name according to ICD-10 diagnosed prior to study participation, etc.) associated with Generalized Anxiety Disorder.
-The validity of the diagnosis of Generalized Anxiety Disorder by GAD-7 and K6 in comparison to the diagnosis by SCID.

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: < 80age old
• Gender: Both

Include criteria

Patients fulfilling all the following criteria will be enrolled in the study:
1. Patients aged more than or equal to 18 years to less than 80 years at the time of signing the informed consent form.
2. Patients who are outpatients at a psychiatrist department except for the first visit.
3. Patients with a principal diagnosis of ICD-10 Code F30-F39 mood (affective) disorders or F40-F4 neurotic, stress-related, and somatoform disorders.
4. Patients with written consent and are willing to participate in the study

Exclude criteria

Ptients will be excluded from the study if any of the following criteria apply:
1. Participants who meet the following based on the applicable ICD-10 category.
a. Patients with mental and behavioral disorders due to psychoactive substance use or diagnosed as addictive within 12-months prior to the start of the study.
b. Patients with a current or past medical history of schizophrenia, delusional disorder, or other
psychotic disorders.
c. Patients currently having dementia.
d. Patients with mood disorder or anxiety disorder due to known physiological conditions.
2. Patients with a history of convulsive disease other than single febrile seizures in childhood.
3. Patients judged to be at risk of suicide by the investigator.
4. Patients who are considered inappropriate to participate in the study by the investigator

Related Information

• Primary Sponsor: Nomoto Keisuke
• Source(s) of Monetary Support: Viatris Pharmaceuticals Japan Inc.