Generalized Anxiety Disorder
Conditions
Keywords
generalized anxiety disorder, randomized controlled trial, psychopharmacology, drug therapy, glutamine
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.
Interventions
DRUGL Glutamine
Powder
DRUGPlacebos
Powder
Sponsors
Instituto de Información e Investigación en Salud Mental A. C.
Hospital Universitario Dr. Jose E. Gonzalez
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 64 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Response on Clinical Global Impression-Improvement | Change from baseline to week 8 | Score of 1 or 2 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Response on Hamilton Anxiety Rating Scale | Change from baseline to week 8 | Reduction of baseline score major or equal to 50 % |
| Reduction of Hamilton Anxiety Rating Scale score | Change from baseline to week 8 | Difference between baseline and final score |
Countries
Mexico
Outcome results
None listed