ISRCTN97185214
Completed
Not Applicable
Modifying risk and severity of relapse in patients with recurrent depression at high suicide risk: translational randomised controlled trial
niversity of Oxford (UK)0 sites300 target enrollmentStarted: January 5, 2010Last updated:
Overview
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- niversity of Oxford (UK)
- Enrollment
- 300
Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
Eligibility Criteria
- Sex
- All
Inclusion Criteria
- •1\. Aged 18 years or over, and not older than 70 years due to the fact that depression in old age has often been found to be related to different factors than depression in earlier stages of life. Male or female.
- •2\. Meeting enhanced Diagnostic and Statistical Manual of Mental Disorders, 4th Edition (DSM\-IV) criteria for a history of recurrent major depression, i.e. history of at least three episodes of depression, two of which must have occurred within the last five years, of which one must have occurred within the last two years. Although previous suicidality is recorded in detail (which allows stratification to be carried out on this basis) participants are not included/excluded from the study on the basis of their prior experience of suicidality.
- •3\. Meeting the National Institute of Mental Health (NIMH) guidelines for recovery or remission at the time of baseline assessment. For the purposes of the trial participants are NOT deemed to be in recovery or remission (and hence are ineligible) if they report a week (or more) during the previous 8 weeks during which they experienced EITHER a core symptom of depression (depressed mood, anhedonia) or suicidal feelings AND at least one other symptom of depression, which together are not accounted for by bereavement or substances/general medical conditions, and which are accompanied by significant impairment in functioning.
- •4\. Giving informed consent
- •5\. Consent received from the participant's General Practitioner
Exclusion Criteria
- •Participants are excluded from the study if one or more of the following apply:
- •1\. They have a history of schizophrenia, schizoaffective disorder, bipolar I disorder, current and severe substance abuse, organic mental disorder, pervasive developmental delay, a primary diagnosis of obsessive\-compulsive disorder or eating disorder, or are currently regularly self\-harming
- •2\. They are showing a positive and continuing response to CBT
- •3\. They have current psychotherapy or counseling more frequently than once per month
- •4\. They are unable to complete the baseline research assessment (e.g. due to difficulties with English, visual impairment, or cognitive difficulties)
Investigators
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