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

September 30, 2015 updated by: Sepideh Kolouri, Shiraz University of Medical Sciences

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

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)

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

70

Phase

  • Phase 2
  • Phase 3

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Persian version of Beck Anxiety Inventory (BAI)
Time Frame: 6 weeks
6 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
side effects of intervention drugs
Time Frame: 6 weeks
6 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shiraz University of Medical Sciences

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2014

Primary Completion (Actual)

March 1, 2015

Study Completion (Actual)

March 1, 2015

Study Registration Dates

First Submitted

September 29, 2015

First Submitted That Met QC Criteria

September 30, 2015

First Posted (Estimate)

October 1, 2015

Study Record Updates

Last Update Posted (Estimate)

October 1, 2015

Last Update Submitted That Met QC Criteria

September 30, 2015

Last Verified

September 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 9470-7440

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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