Efficacy of Nepeta Menthoides Extract on Anxiety of Patients With Depression: a Double-blind Randomized Controlled Clinical Trial

Study Overview
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Brief Summary
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The aim of this study is to assess the efficacy of Nepeta menthoides as an anti anxiety herbal remedy for depressed patients , in a 6 week randomized double-blind controlled trial. A total of 70 adult outpatients between 18-65 ages referring to psychiatry clinic of Shiraz medical university, who having depression according to Persian-language version of the Beck Depression Inventory-Second edition and get score above 11 according to Persian version of Beck Anxiety Inventory (BAI) and diagnosis is confirmed by at two psychiatrists are randomly allocated into two groups and assign to receive 400 mg of freeze dried powder of Nepeta menthoides or 50 mg of sertraline in the uniformed capsules twice daily (in the morning and 1-2 hours before sleeping time at night). Exclusion criteria were pregnancy and lactation, allergy to N. menthoides and Lamiaceae family, patients with suicidal thoughts or previous suicidal attempt, patients with unstable cardiac, renal and hepatic diseases, seizure and hypothyroidism and patients who used substances or alcohol and patients who had indication for electroconvulsive therapy.. Severity of anxiety (by Persian version of Beck Anxiety Inventory (BAI)) and also common possible side effects of drugs will assess in baseline, 2nd week, 4th week and then two weeks after the end of the intervention (in 6th week)

Official Title
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Efficacy of Nepeta Menthoides Boiss & Bohse Freeze Dried Extract on Anxiety of Patients With Depression: a Double-blind Randomized Controlled Clinical Trial

Conditions
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Depression, Anxiety

Intervention / Treatment
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* Drug: Nepeta menthoides Boiss & Bohse freeze dried extract
* Drug: Sertraline


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: having depression according to Persian-language version of the Beck Depression Inventory-Second edition get score above 7 according to Persian version of Beck Anxiety Inventory (BAI) Exclusion Criteria: pregnancy and lactation allergy to N. menthoides and Lamiaceae family patients with suicidal thoughts or previous suicidal attempt patients with unstable cardiac, renal and hepatic diseases, seizure and hypothyroidism patients who used substances or alcohol patients who had indication for electroconvulsive therapy -

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Nepeta menthoides Boiss & Bohse freeze dried extract capsule<br> | Drug: Nepeta menthoides Boiss & Bohse freeze dried extract<br> <br> |
| Active Comparator: Sertraline capsule<br> | Drug: Sertraline<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Persian version of Beck Anxiety Inventory (BAI) |  | 6 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| side effects of intervention drugs |  | 6 weeks |