The Effect of an Edible Algal Extract (Ulva Lactuca) on the Component of Depression in Healthy Volunteers With Anhedonia
Condition: Anhedonia in Healthy Volunteers
MeSH terms: Anhedonia
Study type: Interventional

Summary: 
      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.
    

Detailed description: 
      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).
    

Intervention name(s): Ulva Lactuca; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): The dose was taken with a glass of water during the evening meal once daily; The dose was taken with a glass of water during the evening meal once daily
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Single-centre double-blind randomized placebo-controlled clinical trial on parallel arms of two groups of 45 subjects
Masking: None (Open Label)
Primary purpose: Treatment