GENERALIZED ANXIETY DISORDER
Conditions
Interventions
Treatment period (9 weeks): Participants will receive venlafaxine or placebo 37.5 mg/day - 225 mg/day depending on the dose escalation criteria. At some point during the administration period, all par
Sponsors
Kitano Madoka
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: -Participants with a diagnosis of GAD based on the DSM-5 diagnostic criteria, which is confirmed by the Mini International Neuropsychiatric Interview (MINI). -Participants with a HAM-A total score >= 20 and CGI-S score >= 4 both at the initiation of the screening period and at baseline. -Participants with a GAD-7 total score >= 10 both at the initiation of the screening period and at baseline.
Exclusion criteria
Exclusion criteria: -Participants with a Montgomery-Asberg Depression Rating Scale (MADRS) total score >= 20 at the initiation of the screening period or at baseline. -Participants with an improvement of 20% or more on the HAM-A total score at baseline, compared with the score at the initiation of the placebo lead-in period. -Participants with known hypersensitivity to venlafaxine or desvenlafaxine
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary endpoint will be the change in the HAM-A total score from baseline to treatment completion or discontinuation. | — |
Contacts
Public ContactjRCT Inquiry Contact IQVIA Services Japan G.K.
IQVIA Services Japan G.K
Outcome results
None listed