Status:
UNKNOWN
Thermal Clinic Treatment in Gulf War Illness
Lead Sponsor:
American Society Of Thermalism And Climatology Inc
Conditions:
Posttraumatic Stress Disorder
Eligibility:
All Genders
18-65 years
Phase:
PHASE1
PHASE2
Brief Summary
Although thermal therapy has been utilized in the rehabilitation of war veterans since the Roman Empire, no investigations actually exist about the use of thermal therapy in GWI, This due to the fact ...
Detailed Description
Gulf War illness (GWI) refers to the complex of symptoms that affects veterans of the 1990-1991 Gulf War at significantly excess rates. It is characterized by multiple diverse symptoms not explained b...
Eligibility Criteria
Inclusion
- Patients who are primarily diagnosed with PTSD (Posttraumatic Stress Disorder: 309.81) using DSM-IV-TR criteria. The CAPS-DX (Clinician-Administered PTSD Scale-DX) and M.I.N.I. (The Mini International Neuropsychiatric Interview, Japanese version 5.0.0. \[2003\]) will be used for diagnosis
- Patients aged 18 and \<65 at the time of signing the Informed consent
- Male and female patients
- Inpatient/outpatient status: Both are permitted
- Patients who are able to give written informed consent in person (i.e., patients who are capable of giving written informed consent on their own)
- Patients whose combined score of the CAPS-SX standard B, C, and D is over 50
Exclusion
- Patients primarily diagnosed with a DSM-IV-TR Axis I disorder other than PTSD (e.g. major depressive disorder, dysthymic disorder, specific phobia \[simple phobia\], obsessive-compulsive disorder, panic disorder, etc.) within 6 months of week -4 (start of baseline phase)
- Patients presenting with a current major depressive episode that preceded the diagnosis of PTSD
- Patients who are pregnant, lactating or of childbearing potential and are likely to become pregnant
- Patients receiving another investigational product within 12 weeks before Week -4 (start of baseline phase)
- Patients with a history or complication of manic psychosis
- Patients with a history or complication of convulsive disorder (epilepsy, etc.)
- Patients with a diagnosis or complication of a cognitive disorder (MMSE \<=24 points)
- Patients with a history and complication of serious cerebral organic disorder. (e.g. cerebrovascular disorder, meningitis, degenerative disease and other neurological disorders and seizures; however, bleeding in the upper arachnoid membrane should not be excluded)
- Patients unable or unwilling to undergo the fMRI procedure (e.g., cerebrovascular clipping surgery, pacemaker, any internal metals with magnetism, and claustrophobia)
- Patients with glaucoma
- Patients with a known tendency for bleeding or those with predisposing conditions
- Patients with serious physical symptoms (cardiac, hepatic and renal dysfunction, or hematopoietic dysfunction, etc.). For seriousness, Grade 3 of "Criteria for seriousness of adverse reactions to drugs, etc. (Yakuan No.80)" is used as an index
- Patients with a history or complication of cancer or malignant tumour
- Patients with chronic hepatitis type B and/or C which is positive of hepatitis B surface antigen (HBsAg) and/or hepatitis C antibody
- Others whom the investigator or sub-investigator considers ineligible for or unable to participate in the investigation
Key Trial Info
Start Date :
September 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 1 2016
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT02293291
Start Date
September 1 2014
End Date
October 1 2016
Last Update
June 23 2015
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Gaviota Clinic
Newark, New Jersey, United States, 07105