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Completed

NCT Number: NCT02983734

D-cycloserine: A Novel Treatment for Gulf War Illness (GWDCS)

The purpose of this study is to investigate the efficacy of d-cycloserine (DCS) treatment for Gulf War Illness (GWI). Gulf War veterans with Gulf War Illness experience numerous chronic health symptoms, including cognition and fatigue, which reduces their quality of life. Gulf War veterans are in urgent need of novel treatment plans to tackle elusive symptomatology of Gulf War Illness. By using the literature of previous studies, the investigators have chosen to investigate d-cycloserine as a possible candidate for treating GWI, specifically cognitive symptoms. DCS has been shown to reduce neuroinflammation, regulate glutamate levels, and improve synaptic functioning in key areas of the brain.

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Key information

Conditions

Gulf War Illness Inflammation Nervous System Diseases Neuroinflammatory Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

43 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Boston University

Boston, Massachusetts, 02215, United States

About this study

Our study is a pilot study for the novel treatment of d-cycloserine to treat GWI. Our study will consist of two experimental groups of equal size (n=28): DCS treatment group and a placebo group. Participants will be randomized into either group; with a double blind study design. Participants will be instructed to self-administer their treatment pills once per day for 28 days. There will be a total of 6 study visits that will include medical and neuropsychological assessment. The first visit will be for establishing eligibility and baseline functioning. Three visits (visits 2-4) will occur during the medication trial (day 1, day 2 and two weeks into medication/placebo). Visit 5 will occur around the time medication/placebo is finished. Visit 6 (follow up) will occur one month after medication/placebo is complete.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Veterans of the 1991 Gulf War, male or female
  • Physical examination and laboratory findings within normal limits
  • Willingness and ability to participate in the informed consent process and comply with study protocols
  • Symptom criteria: Meets Gulf War Illness criteria with the cognitive symptom domain being present. Veteran does not have medical exclusions for Gulf War Illness

Exclusion criteria

  • Veteran lacks the capacity to provide consent during the informed consent process
  • Veteran has the one of the following medical exclusion conditions and/or has been active or received treatment within the past 5 years: Cancer (except nonmelanoma skin cancer), diabetes (not well managed), seizure disorder, heart disease (except hypertension), liver disease, kidney disease, Lupus, multiple sclerosis, stroke, chronic infectious disease, immune disorder/immunosuppression
  • Veteran has a history of a major psychiatric or central nervous system disorder that can affect cognitive function (ie. epilepsy, brain tumor, Parkinson's Disease)
  • Veteran has been hospitalized in the past 5 years for depression, PTSD, alcohol or drug dependence
  • Veteran has current suicidal ideation or current alcohol or drug dependence
  • Pregnant women, lactating women, women who are breastfeeding, or women of childbearing potential who are not using medically accepted forms of contraception
  • Veteran is active duty personnel

Treatment and study plan

D-cycloserine

Drug

100mg of DCS will be administered orally in pill form daily for 4 weeks

Other names: DCS

Placebo

Drug

A placebo will be administered orally daily for 4 weeks

Other names: Sugar pill

Primary outcomes

  1. Immediate Recall Using the Logical Memory Test I

    Time frame: 8 weeks

    The Logical Memory Test I will be used to evaluate immediate auditory memory and ability to recall details of orally presented stories right after hearing them. Two stories will be presented and each story contains 25 standard memory details (story units). A participant receives 1 point for every detail they successfully recall. Scores can range from 0 to 50.

  2. Delayed Recall Using the Logical Memory Test II

    Time frame: 8 weeks

    The Logical Memory Test II will be used to evaluate delayed auditory memory and ability to recall details of orally presented stories after a delay of 20-30 minutes after hearing them. Two stories will be presented and each story contains 25 standard memory details (story units). A participant receives 1 point for every detail they successfully recall. Scores can range from 0 to 50.

Secondary outcomes

  1. Overall Psychological Distress or Negative Mood State

    Time frame: 8 weeks

    The Total Mood Disturbance (TMD) score is a comprehensive metric used in psychology and sports science to quantify an individual's overall psychological distress or negative mood state. It is calculated directly from the 65 item Profile of Mood States (POMS) questionnaire where each item is scored on a 5-point Likert scale: 0 = Not at all, 1 = A little, 2 = Moderately, 3 = Quite a lot, 4 = Extremely. . The TMD score combines multiple subscales of mood by summing negative emotional dimensions and subtracting positive ones. Score ranges from -32 to 200. Higher Scores indicate a greater degree of mood disturbance, affective distress, or psychological stress.

  2. Transient Emotional States and Mood Fluctuations Over Time

    Time frame: 8 weeks

    The Profile of Mood States (POMS) is a standard, validated psychological test used to measure transient emotional states and mood fluctuations over time. It consists of 65 words or statements that describe different feelings and emotions. Each item is scored on a 5-point Likert scale: 0 = Not at all, 1 = A little, 2 = Moderately, 3 = Quite a lot, 4 = Extremely. Scores can range from 0-60.

Sponsors and collaborators

Lead sponsor

Boston University Charles River Campus

Other

Collaborators

  • United States Department of Defense

Registry information

Official study title

D-cycloserine: A Novel Treatment for Gulf War Illness

Acronym: GWDCS

Important dates

Study start
2015
Primary completion
2019
Study completion
2019
First posted
Dec 6, 2016
Registry last updated
Sep 9, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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