OSU6162 ADD-ON IN SSRI/SNRI-RESISTANT DEPRESSION

While the selective serotonin reuptake inhibitors (SSRIs) are first line of treatment of depression, 30% of patients do not respond adequately.

Adding an atypical antipsychotic agent to the SSRI may lead to a marked response in these cases, this having become a recommended strategy.

Antipsychotic drugs are, however, marred by serious side effects, such as motor impairment, apathy, and the metabolic syndrome.

OSU6162 is a dopamine stabilizer developed by Nobel prize winner Arvid Carlsson which bears pharmacological similarities to atypical antipsychotics, but which, according to experimental and clinical studies (where it has been tested mainly for the treatment of fatigue), is more activating than these, and entirey devoid of their side effects.

A network of clinicians in Gothenburg, Kungälv, Lund, Stockholm, and Uppsala will now perform a randomized, 5-center, placebo-controlled trial aiming to assess the efficacy and tolerability of OSU6162 as add-on (flexible dose; 6 weeks of treatment; n=80 per group) in patients who have not responded to six weeks of treatment with an SSRI or a serotonin and noradrenaline reuptake inhibitor (SNRI).

Mixed model statistics will be used to compare the groups with respect to the sum score for 6 core items of the Hamilton Depression Rating Scale at week 6. First patient first visit: Q1/2023; last patient last visit: Q4/2025. Patient benefit: an effective and tolerable treatment for SSRI-resistant depression is an important unmet medical need.