Treatment of Adults With Generalized Anxiety Disorder Using Glutamine

Efficacy of L-glutamine for the Treatment of Generalized Anxiety Disorder: a Randomized Controlled Trial

The objective of this randomized clinical trial is to examine the efficacy of L-glutamine for the treatment of generalized anxiety disorder compared versus placebo.

Study Overview

• Status: Terminated
• Conditions: Generalized Anxiety Disorder
• Intervention / Treatment: Drug: L Glutamine; Drug: Placebos

• Study Type: Interventional
• Enrollment (Actual): 38
• Phase: Phase 2

Contacts and Locations

Study Locations

• Mexico
  • Nuevo León
    • Monterrey, Nuevo León, Mexico, 64460
      • Hospital Universitario Dr. Jose E. Gonzalez

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 64 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Outpatients with generalized anxiety disorder defined by the criteria of the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-V)
• Generalized anxiety disorder is the primary psychiatric disorder.
• Untreated patients or; patients treated with paroxetine, sertraline, citalopram, escitalopram, venlafaxine or duloxetine at least for 6 weeks on a stable dose; or patients treated with any benzodiazepine at least for 4 weeks on a stable dose.
• Hamilton Anxiety Rating Scale score major or equal to 20 and a score major or equal to 2 on items 1 and 2 of the same scale at both screening and baseline.
• Clinical Global Impression-Severity major or equal to 4 at both screening and baseline.

Exclusion Criteria:

• Unable to give informed consent.
• Currently participating in another clinical research.
• Any other psychiatric disorder not included in the Anxiety Disorders section of the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-V). Secondary diagnosis of other anxiety disorders are allowed provided the diagnosis is not more prominent than generalized anxiety disorder symptoms.
• Suicide risk as assessed by the researcher at screening or baseline.
• History of substance abuse in the previous six months before the screening visit.
• Suffering a medically relevant or instable disease.
• If woman, being pregnant at screening visit.
• If woman, being breastfeeding.
• A score major or equal to 20 on the Montgomery-Asberg Depression Rating Scale at screening or baseline.
• As judged by a researcher, the patient might not adhere to the intervention or complete follow-up.
• History of use of a banned drug in the past two weeks prior the baseline visit; three weeks in the case of monoamine oxidase inhibitors; one week in the case of fluvoxamine or a tricyclic antidepressant; two weeks for any antipsychotic and; six weeks por long-acting injectable antipsychotics.
• History of use of L-glutamine the most part of the days of the previous month before the baseline visit.
• History of psychotherapy treatment in the past month before the baseline visit.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Experimental group; Patients in this group will receive flexible doses of L-glutamine ranging from 5 to 25 grams once daily for 8 weeks. L-glutamine is administered as a powder dissolved in water.	Drug: L Glutamine; Powder
Placebo Comparator: Placebo group; Patients in this group will receive flexible doses of placebo ranging from 5 to 25 grams once daily for 8 weeks. Placebo is administered as a powder dissolved in water.	Drug: Placebos; Powder

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Response on Clinical Global Impression-Improvement	Score of 1 or 2	Change from baseline to week 8

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Response on Hamilton Anxiety Rating Scale	Reduction of baseline score major or equal to 50 %	Change from baseline to week 8
Reduction of Hamilton Anxiety Rating Scale score	Difference between baseline and final score	Change from baseline to week 8

Collaborators and Investigators

• Sponsor: Hospital Universitario Dr. Jose E. Gonzalez
• Collaborators: Instituto de Información e Investigación en Salud Mental A. C.
• Investigators: Principal Investigator: Luis A Centeno Gándara, MD, Hospital Universitario Dr. Jose E. Gonzalez

Study record dates

Study Major Dates

• Study Start (Actual): January 18, 2019
• Primary Completion (Actual): May 12, 2020
• Study Completion (Actual): May 12, 2020

Study Registration Dates

• First Submitted: February 14, 2020
• First Submitted That Met QC Criteria: February 17, 2020
• First Posted (Actual): February 18, 2020

Study Record Updates

• Last Update Posted (Actual): February 11, 2021
• Last Update Submitted That Met QC Criteria: February 8, 2021
• Last Verified: February 1, 2021

More Information

Terms related to this study

• Keywords: randomized controlled trial; generalized anxiety disorder; glutamine; drug therapy; psychopharmacology
• Additional Relevant MeSH Terms: Mental Disorders; Pathologic Processes; Disease; Anxiety Disorders
• Other Study ID Numbers: PS18-00018

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No