ACTRN12623000500651
Recruiting
未知
Deep Brain Stimulation for Treatment-Refractory Obsessive-Compulsive Disorder: Understanding the Mechanism of Action.
Overview
- Phase
- 未知
- Intervention
- Not specified
- Conditions
- Obsessive-Compulsive Disorder
- Sponsor
- QIMR Berghofer Medical Research Institute
- Enrollment
- 5
- Status
- Recruiting
- Last Updated
- last year
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •To be eligible for participation in the study, participants must meet all of the following criteria:
- •1\)Diagnosis – Participant is diagnosed with Obsessive Compulsive Disorder (OCD) according to DSM\-5 Diagnostic Criteria.
- •2\)Severity – Participant has a Yale Brown Obsessive Compulsive Scale (Y\-BOCS) score of more than or equal to 24, measured twice at least 2 weeks apart.
- •3\)Chronicity – Duration of illness greater than 5 years.
- •4\)Treatment Refractoriness – No or insufficient response following at least
- •2 treatment trials with a Selective Serotonin Reuptake Inhibitor (SSRI), at maximum tolerated dosage for at least 12 weeks, plus
- •1 treatment trial with clomipramine at maximum tolerated dosage for at least 12 weeks, plus
- •1 augmentation trial with an atypical antipsychotic for 8 weeks in combination with one of the above mentioned drugs, plus
- •1 attempted psychotherapy trial (exposure and response prevention or ERP), confirmed by psychotherapist.
- •5\)Aged between 20\-55 years.
Exclusion Criteria
- •Participants with any of the following will not be eligible for enrolment:
- •1\)A lifetime diagnosis of psychotic disorder, current or past (such as schizophrenia, schizoaffective disorder or delusional disorder).
- •2\)Diagnosed manic episode within the last 3 years.
- •3\)Clinical history consistent with severe personality disorder of any type.
- •4\)Current, or unstably remitted substance abuse disorder, the latter being defined by history consistent with substance dependence in the last 12 months, or abuse in the last 6 months, other than nicotine dependence or abuse.
- •5\)Participant is at high risk of suicide:
- •Has made a suicide attempt within the previous 12 months that required medical treatment, or
- •Has made two suicide attempts in the past 12 months, or
- •Has a clear\-cut plan for suicide and states that he/she cannot guarantee that he/she will call his/her regular psychiatrist or the investigator if the impulse to implement the plan becomes substantial during the study, or
- •Is likely to attempt suicide within the next six months, in the investigator’s opinion.
Outcomes
Primary Outcomes
Not specified
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