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Psychotherapy and Pharmacotherapy in Dissociative Disorders

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2009 by Espace Hogan.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
Espace Hogan
ClinicalTrials.gov Identifier:
NCT00630981
First received: February 28, 2008
Last updated: April 16, 2009
Last verified: April 2009
  Purpose

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).


Condition Intervention
Dissociative Disorders
Behavioral: Psychotherapy
Drug: Pharmacological treatment (Quetiapine and/or Escitalopram)

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: The Interest of a Specific Combined Treatment (Psychotherapy and Pharmacotherapy) in Patients With Dissociative Disorders

Resource links provided by NLM:


Further study details as provided by Espace Hogan:

Primary Outcome Measures:
  • 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. [ Time Frame: 8 weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • The relationship between serum lipid levels and depressive symptoms in patients with dissociative disorder during combined treatment. [ Time Frame: 8 weeks ] [ Designated as safety issue: Yes ]

Enrollment: 30
Study Start Date: February 2008
Estimated Study Completion Date: July 2009
Primary Completion Date: April 2009 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Intervention group

Combined psychotherapy and pharmacological treatment

Open single arm 'pilot' clinical trial in patients with dissociative disorders, admitted to the psychiatric emergency unit of Geneva and in the Hogan Psychotherapeutic Center in Montreux.

Patients will be interviewed according to the Dissociative Experiences Scale (DES) and, if their score is 30 or higher, the Structured Clinical Interview for DSM-IV Dissociative Disorders (SCID) will be administered.

Behavioral: Psychotherapy
Specific psychotherapy for dissociative disorders
Other Name: Dissociative Disorders
Drug: Pharmacological treatment (Quetiapine and/or Escitalopram)
Quetiapine for psychotic symptoms/Escitalopram if depressive disorders
Other Names:
  • Seroquel
  • Ketipinor
  • Lexapro
  • Cipralex

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

This will be an open single arm "pilot" clinical trial on patients with dissociative disorders, admitted to the psychiatric emergency unit of Geneva and in the Hogan Psychotherapeutic Center in Montreux. Patients will be interviewed according to the Dissociative Experiences Scale (DES) and, if their score is 30 or higher, the Structured Clinical Interview for DSM-IV Dissociative Disorders (SCID) will be administered and, if the outcome on SCID is positive, the patient can be included in the study.

The patients will be treated by a psychiatrist who has experience with the use of the specific combined treatment for dissociative disorders (Damsa et al., 2005).

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00630981

Locations
Switzerland
HUG
Geneva, Switzerland
Sponsors and Collaborators
Espace Hogan
Investigators
Principal Investigator: Cristian Damsa, MD HUG
  More Information

Publications:
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.
Kelley-Puskas M, Cailhol L, D'Agostino V, Chauvet I, Damsa C. Neurobiologie des troubles dissociatifs. Annales Médico-Psycholgiques 163(10):896-901, 2005.
Lazignac C, Cicotti A, Bortoli A-L, Kelley-Puskas M, Damsa C. Des états dissociatifs vers une clinique des troubles dissociatifs. Annales Médico-Psycholgiques 163(140): 889-895, 2005.
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.
Luborsky L, Barber J, Siqueland L, Johnson S, Najavits LM, Frank A, Daley D. The revised helping alliance questionnaire (HAQII). Journal of psychotherapy practice and research 5: 260-271, 1996.

Responsible Party: Nick Miller MD, Espace Hogan
ClinicalTrials.gov Identifier: NCT00630981     History of Changes
Other Study ID Numbers: 07-111/Psy 07-016, 07-111/Psy 07-016
Study First Received: February 28, 2008
Last Updated: April 16, 2009
Health Authority: Switzerland: Swissmedic

Keywords provided by Espace Hogan:
dissociative disorders

Additional relevant MeSH terms:
Conversion Disorder
Disease
Dissociative Disorders
Mental Disorders
Pathologic Processes
Somatoform Disorders
Citalopram
Dexetimide
Quetiapine
Anti-Dyskinesia Agents
Antidepressive Agents
Antidepressive Agents, Second-Generation
Antiparkinson Agents
Antipsychotic Agents
Autonomic Agents
Central Nervous System Agents
Central Nervous System Depressants
Cholinergic Agents
Cholinergic Antagonists
Molecular Mechanisms of Pharmacological Action
Muscarinic Antagonists
Neurotransmitter Agents
Neurotransmitter Uptake Inhibitors
Parasympatholytics
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Psychotropic Drugs
Serotonin Agents
Serotonin Uptake Inhibitors

ClinicalTrials.gov processed this record on November 20, 2014