Gulf War IllnessPhase 2GWDCSNCT02983734
D-cycloserine: A Novel Treatment for Gulf War Illness (GWDCS)
A Phase 2 study testing D-cycloserine in people with Gulf War Illness, run by Boston University Charles River Campus at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 43 to 85 years
- Conditions the study is for
- Gulf War Illness
- What is being tested?
- D-cycloserine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 22 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2015to 15 Sep 2019
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 43 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Gulf War Illness
- Being tested
- D-cycloserine, Placebo
- Keywords
- Gulf War, D-cycloserine, Neuroinflammation, Cognition, Memory
- Medical subject headings
- Neuroinflammatory Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
D-cycloserineDrug
Also called DCS
100mg of DCS will be administered orally in pill form daily for 4 weeks
PlaceboDrug
Also called Sugar pill
A placebo will be administered orally daily for 4 weeks
| Study group | Role | What they receive |
|---|---|---|
| D-cycloserine (DCS) | Active comparator | 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). Receives: Drug: D-cycloserine |
| Placebo | Placebo comparator | 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. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 8 weeks
Secondary outcomes (2)
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.
Measured: 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.
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2016 (estimated)
- Study startOct 2015
- Primary completion15 Sep 2019
- Study completion15 Sep 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Gulf War IllnessStudies 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boston University Charles River Campus
- Sponsor type
- University, hospital or other
- Collaborators
- United States Department of Defense
- Responsible party
- Principal investigator, RosemaryToomey, Boston University Charles River Campus
- Investigators
- Rosemary Toomey, Ph.D., Principal investigator, Boston University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02983734
- Sponsor's protocol ID
- W81XWH-15-1-0588
- Other IDs
- W81XWH-15-1-0588
- Acronym
- GWDCS
- Status last verified
- Aug 2026
- First submitted
- 29 Nov 2016
- Last updated
- 9 Sep 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- D-cycloserine: A Novel Treatment for Gulf War Illness
- ClinicalTrials.gov ID
- NCT02983734
- Acronym / sponsor ID
- GWDCS / W81XWH-15-1-0588
- Conditions
- Gulf War Illness
- Keywords
- Gulf War, D-cycloserine, Neuroinflammation, Cognition, Memory
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Boston University Charles River CampusUniversity, hospital or other
- Collaborators
- United States Department of Defense
- Study start
- Oct 2015
- Primary completion
- 15 Sep 2019 (actual)
- Study completion
- 15 Sep 2019 (actual)
- First posted
- 6 Dec 2016 (estimated)
- Results
- Posted 9 Sep 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| D-cycloserine (DCS) | Active comparator | Drug: D-cycloserineParticipants 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). |
| Placebo | Placebo comparator | Drug: PlaceboParticipants 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. |
Who may qualify
- Ages
- 43 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (7 listed)
- 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
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 |
|---|---|---|
| D-cycloserineAlso: DCS100mg of DCS will be administered orally in pill form daily for 4 weeks | Drug | D-cycloserine (DCS) |
| PlaceboAlso: Sugar pillA placebo will be administered orally daily for 4 weeks | Drug | Placebo |
Primary outcome
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.
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.
2 secondary outcomes
Overall Psychological Distress or Negative Mood State
Time frame: 8 weeks
Transient Emotional States and Mood Fluctuations Over Time
Time frame: 8 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
Related trials for Gulf War Illness
RecruitingObservational study
NIH Investigative Deep Phenotyping Study of Gulf War Veteran Health (Project NIH IN-DEPTH)
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Ca-Mg Butyrate in Gulf War Illness
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Gulf War Syndrome
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Mechanisms of Gulf War Illness
Gulf War Illness, Irritable Bowel Syndrome
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.
Rosemary Toomey, Ph.D. principal investigator
Boston University
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 D-cycloserine in people with Gulf War Illness, run by Boston University Charles River Campus at 1 site in United States.
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 4 inclusion and 7 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: finished, as of the sponsor's last update on 9 Sep 2026. 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 United States. 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?
Yes. Results are posted in the registry (first posted 9 Sep 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Immediate Recall Using the Logical Memory Test I (time frame: 8 weeks). The study lists 2 primary outcomes in all. 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 9 Sep 2026.