Last updated: February 8, 2021
Sponsor: Hospital Universitario Dr. Jose E. Gonzalez
Overall Status: Terminated
Phase
2
Condition
Anxiety Disorders
Panic Disorders
Mood Disorders
Treatment
N/AClinical Study ID
NCT04274114
PS18-00018
Ages 18-64 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- Outpatients with generalized anxiety disorder defined by the criteria of theDiagnostic 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; orpatients 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 andbaseline.
Exclusion
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 theDiagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-V).Secondary diagnosis of other anxiety disorders are allowed provided the diagnosis isnot 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 atscreening or baseline.
- As judged by a researcher, the patient might not adhere to the intervention orcomplete follow-up.
- History of use of a banned drug in the past two weeks prior the baseline visit; threeweeks in the case of monoamine oxidase inhibitors; one week in the case of fluvoxamineor a tricyclic antidepressant; two weeks for any antipsychotic and; six weeks porlong-acting injectable antipsychotics.
- History of use of L-glutamine the most part of the days of the previous month beforethe baseline visit.
- History of psychotherapy treatment in the past month before the baseline visit.
Study Design
Total Participants: 38
Study Start date:
January 18, 2019
Estimated Completion Date:
May 12, 2020
Connect with a study center
Hospital Universitario Dr. Jose E. Gonzalez
Monterrey, Nuevo León 64460
MexicoSite Not Available

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