Tolerability and Efficacy of High Dose Escitalopram for the Treatment of Obsessive-Compulsive Disorder (OCD)
Information source: Abarbanel Mental Health Center
Information obtained from ClinicalTrials.gov on March 21, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Obsessive-Compulsive Disorder
Intervention: escitalopram (Drug)
Phase: Phase 3
Status: Completed
Sponsored by: Abarbanel Mental Health Center Official(s) and/or principal investigator(s):
Yoram Barak, MD, MHA, Study Director, Affiliation: Abarbanel MHC
Summary
Objectives: To evaluate tolerability and efficacy of escitalopram treatment in high dose
than 20-50 mg/d in out-patients with OCD Type of the study: Open label, prospective study.
Number of patients: 100 patients with OCD
Duration of the study: 18-weeks of active treatment, 8-visits:
Dose titration:
One week of 10mg Four weeks of 20mg After 4 weeks of 20mg treatment– if partial/no response,
according to YBOCS score and clinical judgment, dose increase of up to 50mg depending on
response, adverse events, patient preference and judgment of the clinician 12 weeks follow up
on high dose. Total of 18 weeks of follow-up.
Clinical Details
Official title: Phase III Open Study of High Dose Escitalopram for the Treatment of Obsessive-Compulsive Disorder in Adults
Study design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Primary outcome: Safety as recorded by adverse-events and side-effects reports.
Secondary outcome: Reduction in YBOCS scores at week 18
Detailed description:
Objectives: To evaluate tolerability and efficacy of escitalopram treatment in doses higher
than 20mg (20-50 mg/d) in patients with OCD, non responsive or partially responsive to
recommended doses.
Type of the study: Open label, prospective study. Study location: Subjects will be recruited
from patients treated in a large clinic specializing in mood disorders and anxiety and OCD.
Backup site: the ABARBANEL mental health center. Number of patients: 100 patients with OCD
Duration of the study: 18-weeks of active treatment, 8-visits:
Dose titration:
One week of 10mg Four weeks of 20mg After 4 weeks of 20mg treatment– if partial/no response,
according to YBOCS score and clinical judgment, dose increase of up to 50mg depending on
response, adverse events, patient preference and judgment of the clinician 12 weeks follow up
on high dose. Total of 18 weeks of follow-up.
Patients
Inclusion Criteria:
1. Men and women over 18 years of age
2. DSM IV-TR criteria for OCD
3. OCD associated with most distress or most interference in the patient’s life as judged
by the treating physician
4. Yale-Brown Obsessive Compulsive Scale (YBOCS) total score ≥16
Exclusion Criteria:
1. Other primary or co-primary psychiatric disorder which is more distressful for the
patient then the OCD, as evaluated by investigator
2. Patients with any history of mania/bipolar disorder
3. Patients using medications which are contraindicated with the use of escitalopram
4. Known contraindication for the use of citalopram or escitalopram.
5. Unable to understand and give informed consent
6. Prominent suicidal ideation (2 points or more in the MADRS “suicidal thoughts” item)
7. Alcohol or substance dependence in the past 6 months
8. Major physical illness
9. a) woman currently pregnant or less then 4 weeks after a childbirth Or b) woman
lactating Or c) A woman of childbearing potential not using a medically accepted form of
contraception.
10. Liver function abnormality
11. EKG abnormalities
Study Design:
An institutional review board acknowledged by the Israeli Ministry of Health will approve the
study. After complete description of the study to the patients, written informed consent will
be obtained from patients found eligible and willing to participate. The design will be
open-labeled. The study will last for 18 weeks.
Patients will be evaluated by clinical assessment and by various questionnaires (see “rating
scales” section). Those who will be diagnosed as having OCD and will fulfill the inclusion
and exclusion criteria requirements will start 4 weeks of initial treatment with escitalopram
up to 20mg/d. After 4 weeks those patients who will be evaluated as non-responders (reduction
of Y-BOCS total score by less than 25%) will continue treatment with higher escitalopram
dose.
Dose will be adjusted according to clinical status and the clinician’s judgment up to 50mg/d
of escitalopram. Patients will be evaluated periodically throughout the study for adverse
reactions and psychiatric status by various rating scales as well as a clinical evaluation by
the investigator.
Assessments:
1. Yale-Brown Obsessive Compulsive Scale (Y-BOCS) Symptom Checklist
2. Montgomery Åsberg Depression Rating Scale (MADRS)
3. The Clinical Global Impression scales (CGI) consist of two sub-scales:
The Severity of illness (CGI-S) and the Global improvement (CGI-I).
4. A checklist of serotonergic specific adverse drug reactions + dizziness, bleeding and
ecchymoses checklist
5. Visual Analog Scale (VAS) for assessment of mental well-being at every visit
6. SDS (Sheehan Disability Scale)
7. Recent and concomitant medications at every visit
Eligibility
Minimum age: 18 Years.
Maximum age: 75 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
1. Men and women over 18 years of age
2. DSM IV-TR criteria for OCD
3. OCD associated with most distress or most interference in the patient’s life as judged
by the treating physician
4. Yale-Brown Obsessive Compulsive Scale (YBOCS) total score ≥ 16
Exclusion Criteria:
1. Other primary or co-primary psychiatric disorder which is more distressful for the
patient then the OCD, as evaluated by investigator
2. Patients with any history of mania/bipolar disorder
3. Patients using medications which are contraindicated with the use of escitalopram
4. Known contraindication for the use of citalopram or escitalopram.
5. Unable to understand and give informed consent
6. Prominent suicidal ideation (2 points or more in the MADRS “suicidal thoughts” item)
7. Alcohol or substance dependence in the past 6 months
8. Major physical illness
9. Woman currently pregnant or less then 4 weeks after a childbirth, a woman lactating,
or a woman of childbearing potential not using a medically accepted form of
contraception.
10. Liver function abnormality
11. EKG abnormalities
Locations and Contacts
Abarbanel MHC, Bat-Yam 59100, Israel
Additional Information
Related publications: Stengler-Wenzke K, Muller U, Barthel H, Angermeyer MC, Sabri O, Hesse S. Serotonin transporter imaging with [123I]beta-CIT SPECT before and after one year of citalopram treatment of obsessive-compulsive disorder. Neuropsychobiology. 2006;53(1):40-5. Epub 2006 Jan 4. Fontenelle LF, Mendlowicz MV, Miguel EC, Versiani M. Citalopram plus reboxetine in treatment-resistant obsessive-compulsive disorder. World J Biol Psychiatry. 2005;6(1):57-9.
Starting date: March 2006
Ending date: December 2006
Last updated: July 25, 2006
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