Psychotherapy and Pharmacotherapy in Dissociative Disorders

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT00630981
• Date of registration: 28/02/2008
• Prospective Registration: No
• Primary sponsor: Espace Hogan
• Public title: Psychotherapy and Pharmacotherapy in Dissociative Disorders
• Scientific title: The Interest of a Specific Combined Treatment (Psychotherapy and Pharmacotherapy) in Patients With Dissociative Disorders
• Date of first enrolment: February 2008
• Target sample size: 30
• Recruitment status: Active, not recruiting
• URL: http://clinicaltrials.gov/show/NCT00630981
• Study type: Observational
• Study design: Time Perspective: Prospective
• Phase: N/A

Countries of recruitment

Switzerland

Contacts

• Name: Cristian Damsa, MD
• Affiliation: HUG

Key inclusion & exclusion 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



Age minimum: 18 Years
Age maximum: 65 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Dissociative Disorders

Intervention(s)

Behavioral: Psychotherapy

Drug: Pharmacological treatment (Quetiapine and/or Escitalopram)

Primary Outcome(s)

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(s)

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

Secondary ID(s)

07-111/Psy 07-016

Source(s) of Monetary Support

Please refer to primary and secondary sponsors