Anhedonia in Healthy Volunteers Clinical Trial
Official title:
Essai Clinique randomisé en Double Aveugle Contre Placebo de l'évaluation de l'Effet d'un Extrait d'Algues Comestibles (Ulva Lactuca) Chez Des Volontaires Sains présentant Une anhédonie associée à Une Baisse de Moral
The effects of the seaweed extract were evaluated on the animal model equivalent of depression compared with a control group treated with the carrier (spring water) and a reference group treated with Imipramine and showed significative effect. This clinical trial was intended to confirm in humans the potential efficacy identified in animals. The primary objective was to compare against a placebo the effect of Ulva L.L extract in healthy volunteers whose anhedonia was characterized by a component of depression.
The trial comprised three visits: a medical enrollment visit on D0, an intermediate visit on
D28 and a final visit on D84. A psychologist made a telephone call after 7 days to check
there was no sudden change in the subject's depressive state. During the visits, the subject
was examined by a doctor and the psychometric tests were administered by a psychologist.
Outside the visits, the subject was monitored by a self-reporting questionnaire in the manner
described below.
After obtaining informed written consent and validating the inclusion and exclusion criteria,
notably the absence of MDE as per DSM V, the investigator enrolled the subject in the trial.
The physician described the subject's demographic and general clinical characteristics, the
main medical and surgical history and any current treatment if those pathologies were still
present, and any previous antidepressant, anxiolytic or neuroleptic treatments. The doctor
asked the subject to complete the SHAPS and QIDS -SR questionnaires and item 7 of the HAM-D.
The doctor then handed the subject self-evaluation questionnaires explaining how to complete
them and the dates at which they were to be completed. The physician gave the patient a batch
of the placebo or a batch of Ulva lactuca as per the randomization. The doctor told the
subject a psychologist would be in touch after one week by telephone to check no DSM V
severity criterion had arisen.
The investigating doctor saw the subject again at the four-week intermediate visit and at the
final visit at the end of the 12th week of follow-up. The doctor collected the
self-questionnaires at these visits and the same items as at the enrollment visit were
recorded by the physician for describing how the items had evolved and notably the SHAP scale
score, the QIDS-SR and item 7 of the HAM-D. In addition, the physician recorded the subject's
satisfaction with the treatment evaluated on the PGII (Patient Global Improvement
Impression), reported any undesirable affects and gave his/her own opinion on the efficacy of
treatment using the Clinical Global Improvement Impression (CGII).
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