Anxiety Disorder (AD), anxiety anxiety disorder
Conditions
Interventions
Intervention:  
We will not intervene in patient treatment. Patients will be treated with a SSRI or SNRI according to the physician’s choice. There will be no randomization of treatments, and the DEPREDICT-AD algorit
 
Measurements: 
Assessment of clinical anxiety severity: at baseline, week 2, week 4, and week 12. 
3.0 Tesla MRI including structural imaging (sMRI), diffusion tensor imaging (DTI), resting state MRI (rsfMRI), arterial spin labeling (ASL), and relaxometry, including T1, T2* and Quantitative Suscept
Active EMA: real-time self-reported data on mood, symptoms, and context will be collected via a mobile app for up to three weeks (3–7 days before baseline, and 7 days after weeks 2 and 4. Prompts, del
Passive EMA: data on physical activity, sleep, and HRV will be collected via a wearable device from 3–7 days before baseline to week 5 (up to 6 weeks). 
Sponsors
Amsterdam UMC
Eligibility
Age
18 Years to 64 Years
Inclusion criteria
Inclusion criteria: - Moderate or severe diagnosis of AD based on a structured clinical interview (M.I.N.I.) - Score of =25 on the HAM-A. - In need of pharmacological treatment with AD according to their physician and existing guidelines. - Age 18-65. - Free of psychotropic medications for at least 5 half-lives (e.g. 1 week for most antidepressants, excluding fluoxetine) at baseline. - Fluency in Dutch, sufficient to complete the interviews and (self-report) questionnaires.
Exclusion criteria
Exclusion criteria: - IQ of less than 70 as assessed by the Dutch national adult reading test (Nederlandse Leestest voor Volwassenen (NLV)). - Alcohol and/or drug dependence with high-risk score on these substances (excluding smoking) in the Alcohol, Smoking, and Substance Involvement Screening Test - Lite (ASSIST-Lite). - Recent switch from antidepressants, with fluoxetine as the last prescribed medication. - A history of skull fracture or a severe or disabling medical condition. - Contraindications to MRI scanning - Neurological comorbidities
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main study parameters/endpoints: Primary study parameters/endpoints: Response or non-response, i.e., >50% reduction in HAM-A score at week 12 compared to baseline. The DEPREDICT-AD algorithm's success will be evaluated by its sensitivity and specificity in predicting non-response using baseline and/or week 2 MRI scans and clinical variables. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary: Treatment response (Clinical Global Impression Scale (CGI) score of 1 or 2) and partial response (CGI score of 3) at week 12; worsening defined as CGI scores of 5–7. AD rating scales such as Beck’s Anxiety Inventory (BAI), Penn Worry State Questionnaire (PWSQ), and the Fear Questionnaire (FQ) for comparison to other studies on AD. Wearable data on physical activity, sleep, and HRV. EMA parameters such as mood, symptoms, and (social) context. | — |
Countries
Netherlands
Contacts
Public ContactKE Spaans
Amsterdam UMC
Outcome results
None listed