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

Shiraz University of Medical Sciences

Status and phase: Completed; Phase 3; Phase 2

Conditions: Depression; Anxiety

Treatments: Drug: Nepeta menthoides Boiss & Bohse freeze dried extract; Drug: Sertraline

Study type: Interventional

Funder types: Other

Identifiers

NCT02565316

9470-7440

Details and patient eligibility

About

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)

Enrollment: 70 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. having depression according to Persian-language version of the Beck Depression Inventory-Second edition
2. get score above 7 according to Persian version of Beck Anxiety Inventory (BAI)

Exclusion criteria

1. pregnancy and lactation
2. allergy to N. menthoides and Lamiaceae family
3. patients with suicidal thoughts or previous suicidal attempt
4. patients with unstable cardiac, renal and hepatic diseases, seizure and hypothyroidism
5. patients who used substances or alcohol
6. patients who had indication for electroconvulsive therapy -

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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70 participants in 2 patient groups

Nepeta menthoides Boiss & Bohse freeze dried extract capsule

Active Comparator group

Treatment:

Drug: Nepeta menthoides Boiss & Bohse freeze dried extract

Sertraline capsule

Active Comparator group

Treatment:

Drug: Sertraline