Status:
UNKNOWN
Psychotherapy and Pharmacotherapy in Dissociative Disorders
Lead Sponsor:
Espace Hogan
Conditions:
Dissociative Disorders
Eligibility:
All Genders
18-65 years
Brief Summary
The purpose of this observational study is to measure the efficacy of a specific combined treatment (psychotherapy and pharmacotherapy) on patients with dissociative disorders, in terms of patients wi...
Detailed Description
1. INTRODUCTION 1. Background: Dissociative Disorders are frequent, but poorly understood and under-diagnosed \[Foote et al., 2006; Spiegel, 2006\], especially in psychiatric emergency units \[Laz...
Eligibility Criteria
Inclusion
- Provision of written informed consent
- DES-score greater than 30 and positive (DSM-IV) criteria for dissociative disorder using SCID for DSM IV
- Age 18 - 65 years
- Female patients of childbearing potential must have a negative urinary pregnancy test
- Able to understand and comply with the requirements of the study
- Good physical health as determined by medical history and physical examination.
Exclusion
- Pregnancy/lactation
- Suicidal behaviour requiring hospitalisation or borderline personality disorder
- Substance dependence
- Treatment with psychotropic or cholesterol-lowering medication
- Known intolerance or lack of response to the medication that will be prescribed in the study.
- Unstable or inadequately treated medical illness (e.g. angina pectoris, hypertension, congestive heart failure) as judged by the investigator
- Involvement in the planning and conduct of the study
- Previous enrolment or randomisation of treatment in the present study.
- Participation in another drug trial within 4 weeks prior enrolment into this study or longer in accordance with local requirements
- The cytochrome P450 3A4 inhibitors and inducers
- A patient with Diabetes Mellitus (DM) fulfilling one of the following criteria:
- Unstable DM defined as enrollment glycosylated hemoglobin (HbA1c) \>8.5%.
- Admitted to hospital for treatment of DM or DM related illness in past 12 weeks.
- Not under physician care for DM
- Physician responsible for patient's DM care has not indicated that patient's DM is controlled.
- Physician responsible for patient's DM care has not approved patient's participation in the study
- Has not been on the same dose of oral hypoglycaemic drug(s) and/or diet for the 4 weeks prior to randomization. For thiazolidinediones (glitazones) this period should not be less than 8 Weeks.
- Taking insulin whose daily dose on one occasion in the past 4 weeks has been more than 10% above or below their mean dose in the preceding 4 weeks \*Note: If a diabetic patient meets one of these criteria, the patient is to be excluded even if the treating physician believes that the patient is stable and can participate in the study.
- An absolute neutrophil count (ANC) of greater than 1.5 x 109/L
Key Trial Info
Start Date :
February 1 2008
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
July 1 2009
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT00630981
Start Date
February 1 2008
End Date
July 1 2009
Last Update
April 20 2009
Active Locations (1)
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1
HUG
Geneva, Canton of Geneva, Switzerland