Treatment of Adults With Generalized Anxiety Disorder Using Glutamine

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

38 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-01-18

Study Completion Date

2020-05-12

Brief Summary

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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.

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Detailed Description

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Conditions

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Generalized Anxiety Disorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Experimental group

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.

Group Type EXPERIMENTAL

L Glutamine

Intervention Type DRUG

Powder

Placebo group

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.

Group Type PLACEBO_COMPARATOR

Placebos

Intervention Type DRUG

Powder

Interventions

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L Glutamine

Powder

Intervention Type DRUG

Placebos

Powder

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

64 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No