Time to response in panic disorder in a naturalistic setting: combination therapy with alprazolam orally disintegrating tablets and serotonin reuptake inhibitors compared to serotonin reuptake inhibitors alone.

OBJECTIVE

This study evaluated time to response in the treatment of panic disorder with a selective serotonin reuptake inhibitor (SSRI) or serotonin norepinephrine reuptake inhibitor (SNRI) combined with alprazolam orally disintegrating tablets (ODT), or SSRI/SNRI alone.

DESIGN

Subjects were randomized to eight weeks open-label treatment with alprazolam ODT (4 weeks treatment followed by 3-4 week taper) combined with an SSRI or SNRI, or treatment with SSRI/SNRI alone.

SETTING

The study was conducted under naturalistic conditions at 62 primary care and 34 psychiatric practices.

PARTICIPANTS

Male or female subjects ≥18 years of age diagnosed with panic disorder, with or without agoraphobia.

MEASUREMENTS: The primary efficacy measure was time to response, defined as ≥50-percent decrease from baseline Hamilton Rating Scale for Anxiety (HAM-A) total score. Secondary measures included change from baseline in HAM-A scores and the Clinical Global Impression of Improvement (CGI-I) and Patient Global Impression (PGI) scales.

RESULTS

The intent-to-treat (ITT) population comprised 245 subjects. There was no statistical difference between treatment groups in time to response in the ITT population; however, a prospectively defined per protocol analysis revealed a statistically significant earlier onset of effect in subjects receiving SSRI/SNRI plus alprazolam ODT (P<0.05). Mean change from baseline in HAM-A total score and clinician and patient measures of global improvement also showed statistically significant early advantages for combination therapy compared with SSRI/SNRI monotherapy.

CONCLUSION

Combined treatment of panic disorder with alprazolam ODT and an SSRI/SNRI may be associated with more rapid improvement in anxiety symptoms compared with an SSRI/SNRI alone.