OBJECTIVE: This study investigated the therapeutic potential of initiating treatment of generalized anxiety disorder (GAD) with alprazolam orally disintegrating tablets (ODT) in combination with an SSRI or SNRI, compared with SSRI/SNRI monotherapy. DESIGN: Subjects were randomized to eight weeks open-label treatment with alprazolam ODT (4 weeks treatment followed by a 3- to 4-week taper) combined with an SSRI or SNRI, or treatment with SSRI/SNRI alone. SETTING: The study was conducted at 43 primary care and 22 psychiatric practices under naturalistic conditions. PARTICIPANTS: Subjects ≥ 18 years of age with a primary diagnosis of GAD. MEASUREMENTS: The primary efficacy measure was time to response, a ≥50-percent decrease from baseline in Hamilton Rating Scale for Anxiety (HAM-A) total score. Secondary variables included HAM-A total and sub-factor scores, and the Clinical Global Impression of Improvement (CGI-I) and Patient Global Impression (PGI) scales. RESULTS: The intent-to-treat population included 129 subjects. Discontinuation due to adverse events occurred in one subject in each group. There was no statistical difference between groups in the primary efficacy variable of time to response on the HAM-A. Combination treatment with alprazolam ODT and SSRI/SNRI was associated with statistically significant advantages on prespecified secondary variables including earlier improvement in the HAM-A total score and insomnia item and responses on the CGI-I and PGI scales. CONCLUSION: Combination treatment did not differ from monotherapy on time to response but was associated with more rapid improvement in insomnia and global secondary measures.
RCT Entities:
OBJECTIVE: This study investigated the therapeutic potential of initiating treatment of generalized anxiety disorder (GAD) with alprazolam orally disintegrating tablets (ODT) in combination with an SSRI or SNRI, compared with SSRI/SNRI monotherapy. DESIGN: Subjects were randomized to eight weeks open-label treatment with alprazolam ODT (4 weeks treatment followed by a 3- to 4-week taper) combined with an SSRI or SNRI, or treatment with SSRI/SNRI alone. SETTING: The study was conducted at 43 primary care and 22 psychiatric practices under naturalistic conditions. PARTICIPANTS: Subjects ≥ 18 years of age with a primary diagnosis of GAD. MEASUREMENTS: The primary efficacy measure was time to response, a ≥50-percent decrease from baseline in Hamilton Rating Scale for Anxiety (HAM-A) total score. Secondary variables included HAM-A total and sub-factor scores, and the Clinical Global Impression of Improvement (CGI-I) and Patient Global Impression (PGI) scales. RESULTS: The intent-to-treat population included 129 subjects. Discontinuation due to adverse events occurred in one subject in each group. There was no statistical difference between groups in the primary efficacy variable of time to response on the HAM-A. Combination treatment with alprazolam ODT and SSRI/SNRI was associated with statistically significant advantages on prespecified secondary variables including earlier improvement in the HAM-A total score and insomnia item and responses on the CGI-I and PGI scales. CONCLUSION: Combination treatment did not differ from monotherapy on time to response but was associated with more rapid improvement in insomnia and global secondary measures.
Authors: Ronald C Kessler; Patricia Berglund; Olga Demler; Robert Jin; Kathleen R Merikangas; Ellen E Walters Journal: Arch Gen Psychiatry Date: 2005-06