Treatment of Adults With Generalized Anxiety Disorder Using Glutamine
- Registration Number
- NCT04274114
- Lead Sponsor
- Hospital Universitario Dr. Jose E. Gonzalez
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 38
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Experimental group L Glutamine 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. Placebo group Placebos 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.
- Primary Outcome Measures
Name Time Method Response on Clinical Global Impression-Improvement Change from baseline to week 8 Score of 1 or 2
- Secondary Outcome Measures
Name Time Method Reduction of Hamilton Anxiety Rating Scale score Change from baseline to week 8 Difference between baseline and final score
Response on Hamilton Anxiety Rating Scale Change from baseline to week 8 Reduction of baseline score major or equal to 50 %
Trial Locations
- Locations (1)
Hospital Universitario Dr. Jose E. Gonzalez
🇲🇽Monterrey, Nuevo León, Mexico
Hospital Universitario Dr. Jose E. Gonzalez🇲🇽Monterrey, Nuevo León, Mexico