Generalized Anxiety DisorderPhase 2NCT04274114
Treatment of Adults With Generalized Anxiety Disorder Using Glutamine
A Phase 2 study testing L Glutamine in people with Generalized Anxiety Disorder, run by Hospital Universitario Dr. Jose E. Gonzalez at 1 site in Mexico.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 64 years
- Conditions the study is for
- Generalized Anxiety Disorder
- What is being tested?
- L Glutamine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 38 participants
- Where
- 1 siteMexico
- Study dates
- 18 Jan 2019to 12 May 2020
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 64 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
Mexico1 site
Hospital Universitario Dr. Jose E. Gonzalez
Monterrey, Nuevo León, 64460
About this study
Official title: Efficacy of L-glutamine for the Treatment of Generalized Anxiety Disorder: a Randomized Controlled Trial
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.
- Conditions
- Generalized Anxiety Disorder
- Being tested
- L Glutamine, Placebos
- Keywords
- generalized anxiety disorder, randomized controlled trial, psychopharmacology, drug therapy, glutamine
- Medical subject headings
- Generalized Anxiety Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
L GlutamineDrug
Powder
PlacebosDrug
Powder
| Study group | Role | What they receive |
|---|---|---|
| Experimental group | Experimental | 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. Receives: Drug: L Glutamine |
| Placebo group | Placebo comparator | 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. Receives: Drug: Placebos |
What is being measured
The primary outcome is the main question the study is designed to answer.
Response on Clinical Global Impression-Improvement
Score of 1 or 2
Measured: Change from baseline to week 8
Secondary outcomes (2)
Response on Hamilton Anxiety Rating Scale
Reduction of baseline score major or equal to 50 %
Measured: Change from baseline to week 8
Reduction of Hamilton Anxiety Rating Scale score
Difference between baseline and final score
Measured: Change from baseline to week 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2020
- Study start18 Jan 2019
- Primary completion12 May 2020
- Study completion12 May 2020
Why it stopped: Inhability to recruit further participants due to SARS-CoV-2 pandemics.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Generalized Anxiety DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital Universitario Dr. Jose E. Gonzalez
- Sponsor type
- University, hospital or other
- Collaborators
- Instituto de Información e Investigación en Salud Mental A. C.
- Responsible party
- Principal investigator, José Alfonso Ontiveros Sánchez De la Barquera, Hospital Universitario Dr. Jose E. Gonzalez
- Investigators
- José A Ontiveros Sánchez De la Barquera, MD, PhD, Study chair, Hospital Universitario Dr. Jose E. GonzalezLuis A Centeno Gándara, MD, Principal investigator, Hospital Universitario Dr. Jose E. Gonzalez
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04274114
- Sponsor's protocol ID
- PS18-00018
- Status last verified
- Feb 2021
- First submitted
- 14 Feb 2020
- Last updated
- 11 Feb 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of L-glutamine for the Treatment of Generalized Anxiety Disorder: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04274114
- Acronym / sponsor ID
- PS18-00018
- Conditions
- Generalized Anxiety Disorder
- Keywords
- generalized anxiety disorder, randomized controlled trial, psychopharmacology, drug therapy, glutamine
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Inhability to recruit further participants due to SARS-CoV-2 pandemics.
- Enrolment
- 38 participants (actual)
- Lead sponsor
- Hospital Universitario Dr. Jose E. GonzalezUniversity, hospital or other
- Collaborators
- Instituto de Información e Investigación en Salud Mental A. C.
- Study start
- 18 Jan 2019 (actual)
- Primary completion
- 12 May 2020 (actual)
- Study completion
- 12 May 2020 (actual)
- First posted
- 18 Feb 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental group | Experimental | Drug: L GlutaminePatients 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 | Placebo comparator | Drug: PlacebosPatients 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. |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (13 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| L GlutaminePowder | Drug | Experimental group |
| PlacebosPowder | Drug | Placebo group |
Primary outcome
Response on Clinical Global Impression-Improvement
Time frame: Change from baseline to week 8
Score of 1 or 2
2 secondary outcomes
Response on Hamilton Anxiety Rating Scale
Time frame: Change from baseline to week 8
Reduction of Hamilton Anxiety Rating Scale score
Time frame: Change from baseline to week 8
Results and safety
The study was stopped early (reason given: Inhability to recruit further participants due to SARS-CoV-2 pandemics.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Feb 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
José A Ontiveros Sánchez De la Barquera, MD, PhD study chair
Hospital Universitario Dr. Jose E. Gonzalez
Luis A Centeno Gándara, MD principal investigator
Hospital Universitario Dr. Jose E. Gonzalez
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing L Glutamine in people with Generalized Anxiety Disorder, run by Hospital Universitario Dr. Jose E. Gonzalez at 1 site in Mexico.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 11 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Mexico. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Inhability to recruit further participants due to SARS-CoV-2 pandemics.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Response on Clinical Global Impression-Improvement (time frame: Change from baseline to week 8). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Feb 2021.