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

D-cycloserine: A Novel Treatment for Gulf War Illness

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.

Study Overview

• Status: Completed
• Conditions: Gulf War Illness
• Intervention / Treatment: Drug: D-cycloserine; Drug: Placebo

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 22
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02215
      • Boston University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 43 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: D-cycloserine (DCS); Participants randomized to this arm will receive DCS daily for 4 weeks to compare the efficacy of the novel therapeutic approach of DCS in improving cognitive functioning in Gulf War (GW) veterans with Guld War Illness (GWI).	Drug: D-cycloserine; 100mg of DCS will be administered orally in pill form daily for 4 weeks; Other Names: DCS
Placebo Comparator: Placebo; Participants randomized to this arm will receive a placebo daily for 4 weeks to provide a control group for the novel therapeutic approach of DCS in improving cognitive functioning in GW veterans with GWI.	Drug: Placebo; A placebo will be administered orally daily for 4 weeks; Other Names: Sugar pill

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Immediate Recall Using the Logical Memory Test I	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.	8 weeks
Delayed Recall Using the Logical Memory Test II	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.	8 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall Psychological Distress or Negative Mood State	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.	8 weeks
Transient Emotional States and Mood Fluctuations Over Time	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.	8 weeks

Collaborators and Investigators

• Sponsor: Boston University Charles River Campus
• Collaborators: United States Department of Defense
• Investigators: Principal Investigator: Rosemary Toomey, Ph.D., Boston University

Study record dates

Study Major Dates

• Study Start: October 1, 2015
• Primary Completion (Actual): September 15, 2019
• Study Completion (Actual): September 15, 2019

Study Registration Dates

• First Submitted: November 29, 2016
• First Submitted That Met QC Criteria: December 2, 2016
• First Posted (Estimated): December 6, 2016

Study Record Updates

• Last Update Posted (Actual): September 9, 2026
• Last Update Submitted That Met QC Criteria: August 17, 2026
• Last Verified: August 1, 2026

More Information

Terms related to this study

• Keywords: Neuroinflammation; Memory; Cognition; D-cycloserine; Gulf War
• Additional Relevant MeSH Terms: Nervous System Diseases; Pathologic Processes; Inflammation; Pathological Conditions, Signs and Symptoms; Neuroinflammatory Diseases; Amino Acids, Peptides, and Proteins; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Azoles; Carbohydrates; Amino Acids; Oxazolidinones; Oxazoles; Isoxazoles; Serine; Amino Acids, Neutral; Cycloserine; Sugars
• Other Study ID Numbers: W81XWH-15-1-0588 (Other Grant/Funding Number: Department of Defense)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No