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

NCT02565316 | Completed Phase 2 DMC

• 1 other identifier: 9470-7440
• Study Type: interventional
• Target: 70
• Locations: 0 countries
• Sites: N/A

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)

Conditions

Depression; Anxiety

Outcome Measures

Primary Outcomes (1)

• Persian version of Beck Anxiety Inventory (BAI)

  6 weeks

Secondary Outcomes (1)

• side effects of intervention drugs

  6 weeks

Study Arms (2)

Nepeta menthoides Boiss & Bohse freeze dried extract capsule

ACTIVE COMPARATOR

Drug: Nepeta menthoides Boiss & Bohse freeze dried extract

Sertraline capsule

ACTIVE COMPARATOR

Drug: Sertraline

Interventions

Nepeta menthoides Boiss & Bohse freeze dried extract DRUG

Nepeta menthoides Boiss & Bohse freeze dried extract capsule

Sertraline DRUG

Sertraline capsule

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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 -

Sponsors & Collaborators

• Shiraz University of Medical Sciences: lead

MeSH Terms

Conditions

Depression; Anxiety Disorders

Interventions

Sertraline

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Mental Disorders

Intervention Hierarchy (Ancestors)

1-Naphthylamine; Amines; Organic Chemicals; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Polycyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Shiraz University of Medical Sciences

Study Record Dates

• First Submitted: September 29, 2015
• First Posted: October 1, 2015
• Study Start: November 1, 2014
• Primary Completion: March 1, 2015
• Study Completion: March 1, 2015
• Last Updated: October 1, 2015

Record last verified: 2015-09