Generalized Anxiety Disorder Clinical Trial
Official title:
Efficacy of L-glutamine for the Treatment of Generalized Anxiety Disorder: a Randomized Controlled Trial
Verified date | February 2021 |
Source | Hospital Universitario Dr. Jose E. Gonzalez |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Terminated |
Enrollment | 38 |
Est. completion date | May 12, 2020 |
Est. primary completion date | May 12, 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 64 Years |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
Mexico | Hospital Universitario Dr. Jose E. Gonzalez | Monterrey | Nuevo León |
Lead Sponsor | Collaborator |
---|---|
Hospital Universitario Dr. Jose E. Gonzalez | Instituto de Información e Investigación en Salud Mental A. C. |
Mexico,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Response on Clinical Global Impression-Improvement | Score of 1 or 2 | Change from baseline to week 8 | |
Secondary | Response on Hamilton Anxiety Rating Scale | Reduction of baseline score major or equal to 50 % | Change from baseline to week 8 | |
Secondary | Reduction of Hamilton Anxiety Rating Scale score | Difference between baseline and final score | Change from baseline to week 8 |
Status | Clinical Trial | Phase | |
---|---|---|---|
Terminated |
NCT03420456 -
Transcranial Pulse Near-Infrared Light in Generalized Anxiety Disorder: a Placebo-Controlled Study
|
N/A | |
Active, not recruiting |
NCT05530642 -
An Augmented Training Program for Preventing Post-Traumatic Stress Injuries Among Diverse Public Safety Personnel
|
N/A | |
Withdrawn |
NCT02382224 -
Worry Exposure for Generalized Anxiety Disorder
|
N/A | |
Completed |
NCT02256566 -
Cognitive Training for Mood and Anxiety Disorders
|
N/A | |
Completed |
NCT02306356 -
Internet-delivered Treatment for Children With Anxiety Disorders in a Rural Area; an Open Trial in a Clinical Setting
|
N/A | |
Completed |
NCT01958788 -
Testing Beliefs About Uncertainty in the Treatment of Generalized Anxiety Disorder
|
N/A | |
Completed |
NCT01681329 -
Cognitive-Behavioral Treatment and Interpretation Modification Training for Adults With Generalized Anxiety Disorder
|
N/A | |
Completed |
NCT01337713 -
Efficacy of Massage Therapy in the Treatment of Generalized Anxiety Disorder (GAD)
|
N/A | |
Completed |
NCT01201967 -
A Collaborative Care Program to Improve Treatment of Depression and Anxiety Disorders in Cardiac Patients
|
Phase 4 | |
Completed |
NCT01342120 -
PHARMO Institute Seroquel Safety Study
|
N/A | |
Completed |
NCT01203293 -
Cognitive Behavioral Therapy (CBT) for Latinos With Generalized Anxiety Disorder in the General Medical Sector
|
Phase 1 | |
Completed |
NCT01971203 -
Efficacy of Extended-release Quetiapine (Seroquel XR) as Adjunctive Therapy to Cognitive Behavioral Therapy in the Treat
|
N/A | |
Completed |
NCT00961298 -
An Open Label Trial of Duloxetine in the Treatment of Irritable Bowel Syndrome and Comorbid Generalized Anxiety Disorder
|
Phase 4 | |
Completed |
NCT00711737 -
Study of the Changes in Metabolic Parameters in Patients Treated With Escitalopram for Six Months
|
N/A | |
Completed |
NCT00744627 -
Efficacy and Safety of Vortioxetine (Lu AA21004) for Treatment of Generalized Anxiety Disorder in Adults.
|
Phase 3 | |
Terminated |
NCT01244711 -
Open-Label Pilot Study to Examine the Value of Substituting Quetiapine for Benzodiazepines
|
Phase 4 | |
Completed |
NCT00525226 -
Evaluating the Effects of Stress in Pregnancy
|
N/A | |
Completed |
NCT00537615 -
An Open-label Study to Investigate the Absorption, Metabolism and Excretion of Radiolabeled PD 0332334 in Six Healthy Male Volunteers
|
Phase 1 | |
Completed |
NCT00515242 -
Therapeutic Massage for Generalized Anxiety Disorder
|
Phase 1/Phase 2 | |
Completed |
NCT00368745 -
Efficacy and Safety of Pregabalin vs Placebo for Generalized Anxiety Disorder (GAD) Symptoms in Subjects Discontinuing Benzodiazepine Treatment and Remaining 6 Weeks on Study Medication, Free From Benzodiazepine Use.
|
Phase 3 |