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

Phase 2

Completed

• Conditions: Depression; Anxiety
• Interventions: Drug: Nepeta menthoides Boiss & Bohse freeze dried extract; Drug: Sertraline

• Registration Number: NCT02565316
• Lead Sponsor: Shiraz University of Medical Sciences

Brief Summary

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)

Detailed Description

Not available

Study Timeline

• Study Start: 2014-11
• Primary Completion: 2015-03
• Study Completion: 2015-03
• Status Verified: 2015-09
• Study First Submitted: 2015-09-29
• Study First Submitted QC: 2015-09-30
• Last Update Submitted: 2015-09-30
• Study First Posted: 2015-10-01
• Last Update Posted: 2015-10-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 70

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 -

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Nepeta menthoides Boiss & Bohse freeze dried extract capsule	Nepeta menthoides Boiss & Bohse freeze dried extract	-
Sertraline capsule	Sertraline	-

Primary Outcome Measures

Name	Time	Method
Persian version of Beck Anxiety Inventory (BAI)	6 weeks

Secondary Outcome Measures

Name	Time	Method
side effects of intervention drugs	6 weeks