Tolerability and Efficacy of High Dose Escitalopram for the Treatment of Obsessive-Compulsive Disorder (OCD)
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ClinicalTrials.gov Identifier: NCT00305500 |
Recruitment Status :
Completed
First Posted : March 22, 2006
Last Update Posted : July 26, 2006
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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.
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Obsessive-Compulsive Disorder | Drug: escitalopram | Phase 3 |

Study Type : | Interventional (Clinical Trial) |
Enrollment : | 100 participants |
Allocation: | Non-Randomized |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Phase III Open Study of High Dose Escitalopram for the Treatment of Obsessive-Compulsive Disorder in Adults |
Study Start Date : | March 2006 |
Study Completion Date : | December 2006 |

- Safety as recorded by adverse-events and side-effects reports.
- Reduction in YBOCS scores at week 18

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Ages Eligible for Study: | 18 Years to 75 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Men and women over 18 years of age
- DSM IV-TR criteria for OCD
- OCD associated with most distress or most interference in the patient's life as judged by the treating physician
- Yale-Brown Obsessive Compulsive Scale (YBOCS) total score ≥ 16
Exclusion Criteria:
- Other primary or co-primary psychiatric disorder which is more distressful for the patient then the OCD, as evaluated by investigator
- Patients with any history of mania/bipolar disorder
- Patients using medications which are contraindicated with the use of escitalopram
- Known contraindication for the use of citalopram or escitalopram.
- Unable to understand and give informed consent
- Prominent suicidal ideation (2 points or more in the MADRS "suicidal thoughts" item)
- Alcohol or substance dependence in the past 6 months
- Major physical illness
- 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.
- Liver function abnormality
- EKG abnormalities

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): NCT00305500
Israel | |
Abarbanel MHC | |
Bat-Yam, Israel, 59100 |
Study Director: | Yoram Barak, MD, MHA | Abarbanel MHC |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: | NCT00305500 |
Other Study ID Numbers: |
EscitaHD001 |
First Posted: | March 22, 2006 Key Record Dates |
Last Update Posted: | July 26, 2006 |
Last Verified: | March 2006 |
OCD Escitalopram |
Compulsive Personality Disorder Obsessive-Compulsive Disorder Personality Disorders Mental Disorders Anxiety Disorders Citalopram 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 |