A double-blínd study of the behavioural, psychophysiological and endocrine effects of a short-term drug treatment with Pivagabine (PVG) in patients with hypothalamic amenorrhoea

Objective: the aim of this study was to determine the behavioural, psychophysiological and endocrine effects of a drug, the pivagabine, a modulation of CRF release in patients with hypothalamic amenorrhoea with no signfficant weight loss, receiving the drug to relieve anxious and depressive symptoms that are frequently associated with this disorder. Methods: twenty women with hypothalamic amenorrhoea received 900 mg oral pivagabine for seven consecutive days or placebo according to a double-blind, randomised design. Patients were assessed psychologically with three questionnaires, the Symptom Questionnaire ( SQ), a 92 -item que stionnaire consisting infour scales assessing anxiety, depression, physical symptoms, and hostility, the Crown & Crisp Experiential Index (CCEI), a 48-item, six-scale questionnaire inv e s ti g atin g fr e e and p ho b í c anxi e ty, de p re s s iv e and hy s t e r - oidbehaviour, obsessive traits, and somatic complaints, and the Pisa Stress Questionnaire (PSQ), a 32-item, six-scale questionnaire investigating sense of responsability, vigour, stress disorders, precision, free-time, and hyperactivity. Patients were assessed at baselíne and at the end of the tre atment p e r io d fo r the ir p sy c ho p hy s i o Io g i c al p r ofil e, c o m - PRRoI-s cHIAVE. - Pivagabina - Profilo psicofisiologico Key wonos. - Pivagabine - Psychophysiological profiIe -p ri s in g the s imultaneous r e c o r ding of surface frontal mu s c I e e I e c t r o myographic activity (EMG), Galvanic skin response (GSR) body temperature (T), heart rate (HR) and respiratory rate (RR) during a 6-min stressful mental task and another 6-min. period of recovery. The endocrine asi sessment compriset salivary and plasma cortisol, plasma luteinising hormone follicle stimulating hormone, growth hormone (GH), adrenocorticotropin (ACTH), prolactin, insulin-like growth factor and beta-endorphin levels at baseline and after the end of treatment. Results: pivagabine treatme nt induc e d ú gnific ant decrease in the levels of cortisol and ACTH and increases in GH levels, Baseline-end-point diffirences were found in psychophysiological and psychometric data both in the placebo-treated and the pivagabine-treated groups, but are dfficult to interpret, However, pivagabine induced improventent, as evidentiatea by the scores of the SQ (somatic items) and the CCEI (anxiety, obsessive traits, and total scores). Conclusions: the administration of pivagabine in patients with hypothalamic amenorrhoea seems to induce a reduction of perceived stress and its endocrine correlate. Since the sîudy was carried out on a small sample, it needs replication.