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Inhability to recruit further participants due to SARS-CoV-2 pandemics.
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| Name | Class |
|---|---|
| Instituto de Información e Investigación en Salud Mental A. C. | UNKNOWN |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| L Glutamine | Drug | Powder |
| |
| Placebos |
| Measure | Description | Time Frame |
|---|---|---|
| Response on Clinical Global Impression-Improvement | Score of 1 or 2 | Change from baseline to week 8 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| 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 |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Universitario Dr. Jose E. Gonzalez | Monterrey | Nuevo León | 64460 | Mexico |
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| ID | Term |
|---|---|
| D000098647 | Generalized Anxiety Disorder |
| ID | Term |
|---|---|
| D001008 | Anxiety Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D005973 | Glutamine |
| ID | Term |
|---|---|
| D024361 | Amino Acids, Basic |
| D000596 | Amino Acids |
| D000602 | Amino Acids, Peptides, and Proteins |
| D000599 | Amino Acids, Diamino |
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| Drug |
Powder |
|
| Change from baseline to week 8 |
| D021542 | Amino Acids, Neutral |