Psychotherapy and Pharmacotherapy in Dissociative Disorders

NCT00630981 | Unknown DMC

• 1 other identifier: 07-111/Psy 07-016
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

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).

Conditions

Dissociative Disorders

Keywords

dissociative disorders

Outcome Measures

Primary Outcomes (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.

  8 weeks

Secondary Outcomes (1)

• The relationship between serum lipid levels and depressive symptoms in patients with dissociative disorder during combined treatment.

  8 weeks

Study Arms (1)

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; Drug: Pharmacological treatment (Quetiapine and/or Escitalopram)

Interventions

Psychotherapy BEHAVIORAL

Specific psychotherapy for dissociative disorders

Also known as: Dissociative Disorders

Intervention group

Pharmacological treatment (Quetiapine and/or Escitalopram) DRUG

Quetiapine for psychotic symptoms/Escitalopram if depressive disorders

Also known as: Seroquel, Ketipinor, Lexapro, Cipralex

Intervention group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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).

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Espace Hogan: lead

Study Sites (1)

HUG

Geneva, Canton of Geneva, Switzerland

Location

Related Publications (9)

• 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. doi: 10.1176/appi.ajp.161.11.2121.

  PMID: 15514416 BACKGROUND

• 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.

  BACKGROUND

• 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. French.

  PMID: 16521716 BACKGROUND

• 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. doi: 10.1176/ajp.2006.163.4.623.

  PMID: 16585436 BACKGROUND

• Kelley-Puskas M, Cailhol L, D'Agostino V, Chauvet I, Damsa C. Neurobiologie des troubles dissociatifs. Annales Médico-Psycholgiques 163(10):896-901, 2005.

  BACKGROUND

• 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.

  BACKGROUND

• 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.

  BACKGROUND

• Luborsky L, Barber JP, Siqueland L, Johnson S, Najavits LM, Frank A, Daley D. The Revised Helping Alliance Questionnaire (HAq-II) : Psychometric Properties. J Psychother Pract Res. 1996 Summer;5(3):260-71.

  PMID: 22700294 BACKGROUND

• Spiegel D. Recognizing traumatic dissociation. Am J Psychiatry. 2006 Apr;163(4):566-8. doi: 10.1176/ajp.2006.163.4.566. No abstract available.

  PMID: 16585425 BACKGROUND

MeSH Terms

Conditions

Dissociative Disorders

Interventions

Psychotherapy; Drug Therapy; Quetiapine Fumarate; Escitalopram; Dexetimide

Condition Hierarchy (Ancestors)

Mental Disorders

Intervention Hierarchy (Ancestors)

Behavioral Disciplines and Activities; Therapeutics; Dibenzothiazepines; Thiazepines; Thiepins; Sulfur Compounds; Organic Chemicals; Heterocyclic Compounds, 3-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Propylamines; Amines; Nitriles; Benzofurans; Heterocyclic Compounds, 2-Ring; Piperidones; Piperidines; Heterocyclic Compounds, 1-Ring

Study Officials

• Cristian Damsa, MD

  HUG

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: February 28, 2008
• First Posted: March 7, 2008
• Study Start: February 1, 2008
• Primary Completion: April 1, 2009
• Study Completion: July 1, 2009
• Last Updated: April 20, 2009

Record last verified: 2009-04

Locations

CH (1)