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

Depression Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02565316
• Other study ID #: 9470-7440
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: September 29, 2015
• Last updated: September 30, 2015
• Start date: November 2014
• Est. completion date: March 2015

Study information

• Verified date: September 2015
• Source: Shiraz University of Medical Sciences
• Contact: n/a
• Is FDA regulated: No
• Health authority: Iran: Ethics Committee
• Study type: Interventional

Clinical Trial 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)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70
• Est. completion date: March 2015
• Est. primary completion date: March 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Anxiety
• Anxiety Disorders
• Depression
• Depressive Disorder

Intervention

Drug:
• Nepeta menthoides Boiss & Bohse freeze dried extract

• Sertraline

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Shiraz University of Medical Sciences

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Persian version of Beck Anxiety Inventory (BAI)		6 weeks	Yes
Secondary	side effects of intervention drugs		6 weeks	Yes