- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT02528331
Cognitive Behavioral Strategies and Transcranial Magnetic Stimulation in Obsessive-Compulsive Disorder: Open Label Study (CBT-TMS)
Studieoversikt
Status
Intervensjon / Behandling
Studietype
Registrering (Faktiske)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiesteder
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North Carolina
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Durham, North Carolina, Forente stater, 27705
- Duke University Medical Center
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
Inclusion Criteria
Subjects must meet all of the following inclusion criteria to qualify for enrollment into the study:
- All subjects will be 18 - 65 years of age.
Obsessive-compulsive disorder:
- Subjects will meet the DSM-IV primary diagnosis of obsessive-compulsive
- Y-BOCS total score > 16
- Subjects are willing and able to adhere to the intensive treatment schedule and all required study visits.
Exclusion Criteria
Subjects will be excluded from study participation if one of the following exclusion criteria applies:
- Subjects are unable or unwilling to give informed consent.
- No exclusion criteria for comorbid DSM diagnosis.
Subjects with a clinically defined neurological disorder that caused significant safety concern to receive TMS treatment, including, but not limited to:
- Any condition likely to be associated with increased intracranial pressure.
- Space occupying brain lesion.
- Any history of seizure EXCEPT those therapeutically induced by ECT (childhood febrile seizures are acceptable and these subjects may be included in the study).
- History of stroke.
- Transient ischemic attack within two years.
- Cerebral aneurysm.
- Dementia.
- Mini Mental Status Exam (MMSE-2) score of <24.
- Parkinson's disease.
- Huntington's disease.
- Multiple sclerosis.
- Increased risk of seizure for any reason, including prior diagnosis of increased intracranial pressure (such as after large infarctions or trauma), or currently taking medication that lowers the seizure threshold. Medications that lower the seizure threshold are included in the Prohibited Concomitant Medication (Section 5.8).
Subjects with any of the following treatment histories:
- TMS treatment within 6 months prior to the screening visit.
- Lifetime history of treatment with Deep Brain Stimulation
- Use of any investigational drug or device within 4 weeks of the randomization visit.
- If participating in psychotherapy, must have been in stable treatment for at least 2 months prior to entry into the study, with no anticipation of change in the frequency of therapeutic sessions, or the therapeutic focus over the duration of the trial.
- Recent 2-month medication changes
Contraindication to receive TMS:
- Cardiac pacemakers, implanted medication pumps, intracardiac lines, or acute, unstable cardiac disease.
- Intracranial implant (e.g., aneurysm clips, shunts, stimulators, cochlear implants, stents, or electrodes) or any other metal object within or near the head, excluding the mouth, which cannot be safely removed.
- Clinically significant abnormality or clinically significant unstable medical condition, as indicated by medical history, physical examination, ECG results, or clinical laboratory testing, that in the Investigator's judgment might pose a potential safety risk to the subject or limit interpretation of the trial results, e.g., any uncontrolled thyroid disorders, hepatic, cardiac, pulmonary and renal malfunctioning.
- Women who are currently pregnant or not using a medically acceptable means of birth control and women who are breastfeeding.
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Tildeling: N/A
- Intervensjonsmodell: Enkeltgruppeoppdrag
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
---|---|
Eksperimentell: rTMS and Cognitive Behavior Therapy
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
Remission Rate, as Measured by Y-BOCS
Tidsramme: 6 weeks
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Remission is defined as end-point Yale-Brown Obsessive Compulsive Scale (Y-BOCS) score less than the value of 16.
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6 weeks
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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
Complete Response, as Measured by Y-BOCS
Tidsramme: 6 weeks
|
Complete response is defined as a reduction of Y-BOCS score greater than 35%.
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6 weeks
|
Partial Response Rate, as Measured by Y-BOCS
Tidsramme: 6 weeks
|
Partial response is defined as a reduction of greater than 25%.
|
6 weeks
|
Percentage of Adverse Events
Tidsramme: 6 weeks
|
6 weeks
|
Samarbeidspartnere og etterforskere
Sponsor
Etterforskere
- Hovedetterforsker: Richard Weiner, MD, Duke University
Studierekorddatoer
Studer hoveddatoer
Studiestart
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Anslag)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- Pro00047168
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .
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