Clinical trial NCT04274114: 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
Overall status: TERMINATED
Phase: PHASE2
Conditions: Generalized Anxiety Disorder
Keywords: generalized anxiety disorder
randomized controlled trial
psychopharmacology
drug therapy
glutamine
Lead sponsor: Hospital Universitario Dr. Jose E. Gonzalez
Sponsor class: OTHER
Collaborators: name: Instituto de Información e Investigación en Salud Mental A. C.
First posted: 2020-02-18
Enrollment: 38
Sex: ALL
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Response on Clinical Global Impression-Improvement
timeFrame: Change from baseline to week 8
Secondary outcomes:
measure: Response on Hamilton Anxiety Rating Scale
timeFrame: Change from baseline to week 8
measure: Reduction of Hamilton Anxiety Rating Scale score
timeFrame: Change from baseline to week 8
Other outcomes:
Locations:
city: Monterrey
country: Mexico
facility: Hospital Universitario Dr. Jose E. Gonzalez
state: Nuevo León
Study officials:
affiliation: Hospital Universitario Dr. Jose E. Gonzalez
name: José A Ontiveros Sánchez De la Barquera, MD, PhD
role: STUDY_CHAIR
affiliation: Hospital Universitario Dr. Jose E. Gonzalez
name: Luis A Centeno Gándara, MD
role: PRINCIPAL_INVESTIGATOR
References: