Dissociative Disorders Clinical Trial
Official title:
The Interest of a Specific Combined Treatment (Psychotherapy and Pharmacotherapy) in Patients With Dissociative Disorders
Verified date | April 2009 |
Source | Espace Hogan |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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 with a favorable outcome by means of the Dissociative Experiences Scale (DES).
Status | Unknown status |
Enrollment | 30 |
Est. completion date | July 2009 |
Est. primary completion date | April 2009 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 65 Years |
Eligibility |
Inclusion Criteria: 1. Provision of written informed consent 2. DES-score greater than 30 and positive (DSM-IV) criteria for dissociative disorder using SCID for DSM IV 3. Age 18 - 65 years 4. Female patients of childbearing potential must have a negative urinary pregnancy test 5. Able to understand and comply with the requirements of the study 6. Good physical health as determined by medical history and physical examination. Exclusion Criteria: 1. Pregnancy/lactation 2. Suicidal behaviour requiring hospitalisation or borderline personality disorder 3. Substance dependence 4. Treatment with psychotropic or cholesterol-lowering medication 5. Known intolerance or lack of response to the medication that will be prescribed in the study. 6. Unstable or inadequately treated medical illness (e.g. angina pectoris, hypertension, congestive heart failure) as judged by the investigator 7. Involvement in the planning and conduct of the study 8. Previous enrolment or randomisation of treatment in the present study. 9. Participation in another drug trial within 4 weeks prior enrolment into this study or longer in accordance with local requirements 10. The cytochrome P450 3A4 inhibitors and inducers 11. 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. 12. An absolute neutrophil count (ANC) of greater than 1.5 x 109/L |
Country | Name | City | State |
---|---|---|---|
Switzerland | HUG | Geneva |
Lead Sponsor | Collaborator |
---|---|
Espace Hogan |
Switzerland,
Agargun MY, Ozer OA, Kara H, Sekeroglu R, Selvi Y, Eryonucu B. Serum lipid levels in patients with dissociative disorder. Am J Psychiatry. 2004 Nov;161(11):2121-3. — View Citation
Damsa C, Lazignac C, Pirrotta R, Andreoli A. [Dissociative disorders: clinical, neurobiological and therapeutical approaches]. Rev Med Suisse. 2006 Feb 8;2(52):400-5. Review. French. — View Citation
Damsa C, Pirrotta R, Adam E, Hyams H, Lazignac C, Ducrocq F. Approche thérapeutique des troubles dissociatifs. Annales Médico-Psycholgiques 163(10):902-908, 2005.
Foote B, Smolin Y, Kaplan M, Legatt ME, Lipschitz D. Prevalence of dissociative disorders in psychiatric outpatients. Am J Psychiatry. 2006 Apr;163(4):623-9. — View Citation
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Luborsky L. Helping Alliances in psychotherapy: The groundwork for a study of their relationship to its outcome. In: J.L. Cleghhorn (Ed.), Successful psychotherapy. New York, Brunner/Mazel, 92-116, 1976.
Spiegel D. Recognizing traumatic dissociation. Am J Psychiatry. 2006 Apr;163(4):566-8. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | To study the efficacy of a specific combined treatment (psychotherapy and pharmacotherapy) on patients with dissociative disorders, in terms of patients with a favorable outcome by means of the DES scale. | 8 weeks | ||
Secondary | The relationship between serum lipid levels and depressive symptoms in patients with dissociative disorder during combined treatment. | 8 weeks |
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