Several case reports and small, placebo-controlled-trials have reported improvements in cognition and negative symptoms when galantamine has been prescribed adjunctively to patients with schizophrenia. We report our findings from a nine-month, open-label, pilot study to evaluate the long-term efficacy of adjunctive galantamine for the treatment of functional impairments in outpatients with chronic schizophrenia or schizoaffective disorder.

Fourteen outpatients were initiated to open-label treatment with galantamine (8, 12 or 24 mg/day, dependent on tolerance with a target dose of 24 mg/day). The primary outcome measures were competence in activities of daily living as assessed with the Independent Living Scale (ILS), quality of life as assessed with the Quality of Life Scale (QLS), and negative symptoms as measured with the Scale for the Assessment of Negative Symptoms (SANS).

Of the 14 subjects who began treatment, six subjects completed the nine-month study. No significant changes were observed between baseline and either end of study or month 5 on any of the outcome measures. Three subjects withdrew due to an exacerbation of psychotic symptoms and/or a lack of treatment response; one withdrew due to weight gain; and four withdrew for reasons unrelated to the study drug. After a few months treatment, three subjects experienced an overall increase in activation and an associated increase in psychotic and mood symptoms.

Treatment with adjunctive galantamine did not yield functional improvements and may have been associated with agitation and decompensation. Clinical caution and further research are warranted.