Treatment of Adults With Generalized Anxiety Disorder Using Glutamine

NCT04274114 | Terminated Phase 2

• 1 other identifier: PS18-00018
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 1

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.

Conditions

Generalized Anxiety Disorder

Keywords

generalized anxiety disorder; randomized controlled trial; psychopharmacology; drug therapy; glutamine

Outcome Measures

Primary Outcomes (1)

• Response on Clinical Global Impression-Improvement

  Score of 1 or 2

  Change from baseline to week 8

Secondary Outcomes (2)

• Response on Hamilton Anxiety Rating Scale

  Change from baseline to week 8

• Reduction of Hamilton Anxiety Rating Scale score

  Change from baseline to week 8

Study Arms (2)

Experimental group

EXPERIMENTAL

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

Placebo group

PLACEBO COMPARATOR

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

Interventions

L Glutamine DRUG

Powder

Experimental group

Placebos DRUG

Powder

Placebo group

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hospital Universitario Dr. Jose E. Gonzalez: lead
• Instituto de Información e Investigación en Salud Mental A. C.: collaborator

Study Sites (1)

Hospital Universitario Dr. Jose E. Gonzalez

Monterrey, Nuevo León, 64460, Mexico

Location

MeSH Terms

Conditions

Generalized Anxiety Disorder

Interventions

Glutamine

Condition Hierarchy (Ancestors)

Anxiety Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Amino Acids, Basic; Amino Acids; Amino Acids, Peptides, and Proteins; Amino Acids, Diamino; Amino Acids, Neutral

Study Officials

• José A Ontiveros Sánchez De la Barquera, MD, PhD

  Hospital Universitario Dr. Jose E. Gonzalez

  STUDY CHAIR

• Luis A Centeno Gándara, MD

  Hospital Universitario Dr. Jose E. Gonzalez

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: February 14, 2020
• First Posted: February 18, 2020
• Study Start: January 18, 2019
• Primary Completion: May 12, 2020
• Study Completion: May 12, 2020
• Last Updated: February 11, 2021

Record last verified: 2021-02

Locations

ME (1)