Nexstim has reported results from its pilot study on the use of accelerated intermittent theta burst stimulation (iTBS) protocol in treatment of severe depression with Nexstim Navigated Brain Therapy (NBT) System at Kuopio University Hospital, Finland.
The open label pilot study (NCT03680781) examined the use of accelerated iTBS protocol in treatment of treatment-resistant depression with Nexstim NBT system.
Accelerated iTBS is transcranial magnetic stimulation (TMS) therapy where stimulation is given several times per day for one week whereas in conventional TMS therapy stimulation is given once a day for several weeks.
The Finland-based company announced that all patients treated with the accelerated iTBS protocol had completed their 5-day treatment, including a total of twenty patients that completed their planned 12-week follow-up.
No device related serious adverse events occurred during the pilot trial.
All patients reported an improvement of symptoms on the clinician administered Hamilton Depression Rating Scale (HAMD-17) outcome measure at the end of treatment except one patient with no change (mean decrease in score from baseline 27%, p<0.001).
At the end of the five-day treatment, 15% out of the total of twenty patients had reached clinical remission and 30% a clinical response defined as more than 50% improvement on the measure.
At the end of the 12-week follow-up period 25% of the patients were in clinical remission and 30% demonstrated a clinical response compared with the baseline HAMD-17 score.
Apart from the generic selective serotonin reuptake inhibitors (SSRIs), which are the standard of care for depression.
There are several alternative drugs currently in the pipeline and in the market for severe or treatment resistant depression, including Janssen’s oral pill and nasal spray, and Biogen and Sage Therapeutics’ Zuranolone.
Otsuka Pharmaceutical is a key player in the depression drug landscape. GlobalData forecasts global sales of over $3.2 billion for Rexulti (brexpiprazole) in 2027.
