Treatment of Adults With Generalized Anxiety Disorder Using Glutamine

Study Overview
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Brief Summary
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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.

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

Conditions
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Generalized Anxiety Disorder

Intervention / Treatment
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* Drug: L Glutamine
* Drug: Placebos


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 64 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental group<br>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<br>* Powder<br>|
| Placebo Comparator: Placebo group<br>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<br>* Powder<br>|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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generalized anxiety disorder, randomized controlled trial, psychopharmacology, drug therapy, glutamine