Generalized anxiety disorder. Anxiety that is generalized and persistent but not restricted to, or even strongly predominating in, any particular environmental circumstances (i.e. it is "free-floating"). The dominant symptoms are variable but include complaints of persistent nervousne
Conditions
Interventions
Intervention 1: Intervention group: sertraline plus probiotic supplement Contain Bifidobacterium Longom, Bifidobacterium bifidum, Bifidobacterium lactis, Lactobacillus acidophilus(18×109 CFU) and sma
Treatment - Drugs
Intervention group: sertraline plus probiotic supplement Contain Bifidobacterium Longom, Bifidobacterium bifidum, Bifidobacterium lactis, Lactobacillus acidophilus(18×109 CFU) and small amounts of fr
control group: sertraline plus placebo capsule contains 220 mg starch, daily, after lunch for 8 weeks
Sponsors
Vice-chancellor for research, Iran University of Medical Sciences
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: Inclusion criteria: DSM-V diagnosed of GAD; Adults between 18 and 65 years old; Willing to participate. exclusion criteria: Having illness including liver disease and kidney disease, diabetes, immune deficiency, etc; Having psychological illnesses including psychosis, Suicidal ideation, bipolar disorder and major depression; People who are expected to have limited partnerships such as forgetfulness and pregnancy; Taking any medication in the previous 1 month; Taking any medication related to psychiatric diseases including antidepressants, antipsychotics, etc. (maximum of two times per week) and antibiotics in the previous 1 month; Taking any supplement including probiotic supplement, fiber, prebiotics, omega-3, vitamins and minerals in the previous 1 month; Consumption of fermented foods (except yogurt), such as sour cream, acidophilus milk, kefir and some cheeses such as blue vein cheese or Swiss cheese in the previous 1 month; substance abuse; The compliance less than 80%.
Exclusion criteria
Exclusion criteria:
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Symptom severity. Timepoint: at baseline, after 1 month and after 2 month. Method of measurement: Beck Anxiety Inventory, Hamilton Rating Scale for anxiety and State-Trait Anxiety Inventory questionnaires.;Plasma acth. Timepoint: at baseline, after 1 month and after 2 month. Method of measurement: Electro-chemiluminescence immunoassay.;Serum cortisol. Timepoint: at baseline, after 1 month and after 2 month. Method of measurement: Chemiluminescence immunoassay.;Quality of life. Timepoint: at baseline, after 1 month and after 2 month. Method of measurement: quality of life, world health organization questionnaire. | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactSevda Eskandrazadeh
Iran University of Medical Sciences
Outcome results
None listed