Treatment of Adults With Generalized Anxiety Disorder Using Glutamine

Generalized Anxiety Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04274114
• Other study ID #: PS18-00018
• Status: Terminated
• Phase: Phase 2
• Start date: January 18, 2019
• Est. completion date: May 12, 2020

Study information

• Verified date: February 2021
• Source: Hospital Universitario Dr. Jose E. Gonzalez
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 38
• Est. completion date: May 12, 2020
• Est. primary completion date: May 12, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 64 Years

Eligibility

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.

Related Conditions & MeSH terms

• Anxiety Disorders
• Disease
• Generalized Anxiety Disorder

Intervention

Drug:
• L Glutamine
Powder
• Placebos
Powder

Locations

Country	Name	City	State
Mexico	Hospital Universitario Dr. Jose E. Gonzalez	Monterrey	Nuevo León

Sponsors (2)

Lead Sponsor	Collaborator
Hospital Universitario Dr. Jose E. Gonzalez	Instituto de Información e Investigación en Salud Mental A. C.

Country where clinical trial is conducted

Mexico, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Response on Clinical Global Impression-Improvement	Score of 1 or 2	Change from baseline to week 8
Secondary	Response on Hamilton Anxiety Rating Scale	Reduction of baseline score major or equal to 50 %	Change from baseline to week 8
Secondary	Reduction of Hamilton Anxiety Rating Scale score	Difference between baseline and final score	Change from baseline to week 8