Status:
TERMINATED
Treatment of Adults With Generalized Anxiety Disorder Using Glutamine
Lead Sponsor:
Hospital Universitario Dr. Jose E. Gonzalez
Collaborating Sponsors:
Instituto de Información e Investigación en Salud Mental A. C.
Conditions:
Generalized Anxiety Disorder
Eligibility:
All Genders
18-64 years
Phase:
PHASE2
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
- 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
- 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.
Key Trial Info
Start Date :
January 18 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 12 2020
Estimated Enrollment :
38 Patients enrolled
Trial Details
Trial ID
NCT04274114
Start Date
January 18 2019
End Date
May 12 2020
Last Update
February 11 2021
Active Locations (1)
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1
Hospital Universitario Dr. Jose E. Gonzalez
Monterrey, Nuevo León, Mexico, 64460