Objective: This open-label investigation evaluated the efficacy and safety of adjunctive galantamine therapy in chronic schizophrenia, including negative and positive symptoms, cognitive domains, and social functioning.
Background: Recently, disturbances in neural transmission mediated by the a7 subtype of nicotinic receptor, an ancestral oligopentameric protein complex, have been implicated in the pathophysiology of schizophrenia. The a7 nicotinic receptor is a cationic channel allowing calcium ion entry; its gating is controlled by acetylcholine and choline. The a7 nicotinic receptor mediates fast type 1A nicotinic responses characterized by rapid decay. This receptor is involved prominently in sensory gating and smooth pursuit eye movement, 2 psychopathologic functions that are disturbed in patients with schizophrenia and closely related biologic relatives. The existence of a selective nicotinic cholinergic abnormality in schizophrenia prompted the examination of the potential adjuvant therapeutic use of galantamine in patients with chronic schizophrenia and persistent deficit symptoms. In addition to its pharmacologic property of inhibition of acetylcholinesterase, galantamine is a positive allosteric modulator of nicotinic neurotransmission, increasing the likelihood that acetylcholine will promote cationic conductance.
Design: Twenty inpatients fulfilled the DSM-IV-R criteria for schizophrenia and were enrolled in this 5-month study. Baseline assessments were made before administration of adjunctive therapy with galantamine 24 mg/day. Tolerability and safety were monitored daily; efficacy was assessed at the end of 3, 4, and 5 months of active treatment with galantamine. Efficacy assessments included the Repeatable Battery for the Assessment of Neuropsychological Status (RANS), Brief Psychiatric Rating Scale (BPRS), Scale for the Assessment of Negative Symptoms (SANS), Montgomery-Asberg Depression Rating Scale (MADRS), Neuropsychiatric Inventory (NPI), Clinical Global Impression Scale (CGI), and Apathy Evaluation Scale (AES). Daily functioning was assessed using the Nurses Observation Scale for Inpatient Evaluation (NOSIE-30). Additionally, motor and movement side effects were assessed using the Simpson-Angus Extrapyramidal Symptom Rating Scale (EPRS), Barnes Akathisia Scale (BAS), and Abnormal Involuntary Movements Scale (AIMS).
Results: Preliminary results of this trial are being reported.
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