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Psychotherapy and Pharmacotherapy in Dissociative Disorders

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ClinicalTrials.gov Identifier: NCT00630981
Recruitment Status : Unknown
Verified April 2009 by Espace Hogan.
Recruitment status was:  Active, not recruiting
First Posted : March 7, 2008
Last Update Posted : April 20, 2009
Sponsor:
Information provided by:
Espace Hogan

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 with a favorable outcome by means of the Dissociative Experiences Scale (DES).

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

  Show Detailed Description

Study Type : Observational
Actual Enrollment : 30 participants
Time Perspective: Prospective
Official Title: The Interest of a Specific Combined Treatment (Psychotherapy and Pharmacotherapy) in Patients With Dissociative Disorders
Study Start Date : February 2008
Primary Completion Date : April 2009
Estimated Study Completion Date : July 2009

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Group/Cohort Intervention/treatment
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



Primary Outcome Measures :
  1. 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 ]

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


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00630981


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

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.

Responsible Party: Nick Miller MD, Espace Hogan
ClinicalTrials.gov Identifier: NCT00630981     History of Changes
Other Study ID Numbers: 07-111/Psy 07-016
First Posted: March 7, 2008    Key Record Dates
Last Update Posted: April 20, 2009
Last Verified: April 2009

Keywords provided by Espace Hogan:
dissociative disorders

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