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Treatment of Adults With Generalized Anxiety Disorder Using Glutamine

Primary Purpose

Generalized Anxiety Disorder

Status
Terminated
Phase
Phase 2
Locations
Mexico
Study Type
Interventional
Intervention
L Glutamine
Placebos
Sponsored by
Hospital Universitario Dr. Jose E. Gonzalez
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Generalized Anxiety Disorder focused on measuring generalized anxiety disorder, randomized controlled trial, psychopharmacology, drug therapy, glutamine

Eligibility Criteria

18 Years - 64 Years (Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Hospital Universitario Dr. Jose E. Gonzalez

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Experimental group

Placebo group

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Response on Clinical Global Impression-Improvement
Score of 1 or 2

Secondary Outcome Measures

Response on Hamilton Anxiety Rating Scale
Reduction of baseline score major or equal to 50 %
Reduction of Hamilton Anxiety Rating Scale score
Difference between baseline and final score

Full Information

First Posted
February 14, 2020
Last Updated
February 8, 2021
Sponsor
Hospital Universitario Dr. Jose E. Gonzalez
Collaborators
Instituto de Información e Investigación en Salud Mental A. C.
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1. Study Identification

Unique Protocol Identification Number
NCT04274114
Brief Title
Treatment of Adults With Generalized Anxiety Disorder Using Glutamine
Official Title
Efficacy of L-glutamine for the Treatment of Generalized Anxiety Disorder: a Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
February 2021
Overall Recruitment Status
Terminated
Why Stopped
Inhability to recruit further participants due to SARS-CoV-2 pandemics.
Study Start Date
January 18, 2019 (Actual)
Primary Completion Date
May 12, 2020 (Actual)
Study Completion Date
May 12, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hospital Universitario Dr. Jose E. Gonzalez
Collaborators
Instituto de Información e Investigación en Salud Mental A. C.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Generalized Anxiety Disorder
Keywords
generalized anxiety disorder, randomized controlled trial, psychopharmacology, drug therapy, glutamine

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
38 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Experimental group
Arm Type
Experimental
Arm Description
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.
Arm Title
Placebo group
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
L Glutamine
Intervention Description
Powder
Intervention Type
Drug
Intervention Name(s)
Placebos
Intervention Description
Powder
Primary Outcome Measure Information:
Title
Response on Clinical Global Impression-Improvement
Description
Score of 1 or 2
Time Frame
Change from baseline to week 8
Secondary Outcome Measure Information:
Title
Response on Hamilton Anxiety Rating Scale
Description
Reduction of baseline score major or equal to 50 %
Time Frame
Change from baseline to week 8
Title
Reduction of Hamilton Anxiety Rating Scale score
Description
Difference between baseline and final score
Time Frame
Change from baseline to week 8

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
64 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
José A Ontiveros Sánchez De la Barquera, MD, PhD
Organizational Affiliation
Hospital Universitario Dr. Jose E. Gonzalez
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Luis A Centeno Gándara, MD
Organizational Affiliation
Hospital Universitario Dr. Jose E. Gonzalez
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital Universitario Dr. Jose E. Gonzalez
City
Monterrey
State/Province
Nuevo León
ZIP/Postal Code
64460
Country
Mexico

12. IPD Sharing Statement

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Treatment of Adults With Generalized Anxiety Disorder Using Glutamine

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