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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.
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:
Exclusion Criteria:
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:
Yale-Brown Obsessive Compulsive Scale (Y-BOCS) Symptom Checklist
Montgomery Ã…sberg Depression Rating Scale (MADRS)
The Clinical Global Impression scales (CGI) consist of two sub-scales:
The Severity of illness (CGI-S) and the Global improvement (CGI-I).
A checklist of serotonergic specific adverse drug reactions + dizziness, bleeding and ecchymoses checklist
Visual Analog Scale (VAS) for assessment of mental well-being at every visit
SDS (Sheehan Disability Scale)
Recent and concomitant medications at every visit
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| escitalopram | Drug |
| Measure | Description | Time Frame |
|---|---|---|
| Safety as recorded by adverse-events and side-effects reports. |
| Measure | Description | Time Frame |
|---|---|---|
| Reduction in YBOCS scores at week 18 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Yoram Barak, MD, MHA | Abarbanel MHC | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Abarbanel MHC | Bat Yam | 59100 | Israel |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 16397403 | Background | 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. doi: 10.1159/000090702. Epub 2006 Jan 4. | |
| 16097406 | Background |
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| ID | Term |
|---|---|
| D009771 | Obsessive-Compulsive Disorder |
| ID | Term |
|---|---|
| D001008 | Anxiety Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D000089983 | Escitalopram |
| ID | Term |
|---|---|
| D011437 | Propylamines |
| D000588 | Amines |
| D009930 | Organic Chemicals |
| D009570 | Nitriles |
| D001572 |
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| 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. doi: 10.1080/15622970510029740. |
| 18090508 | Derived | Rabinowitz I, Baruch Y, Barak Y. High-dose escitalopram for the treatment of obsessive-compulsive disorder. Int Clin Psychopharmacol. 2008 Jan;23(1):49-53. doi: 10.1097/YIC.0b013e3282f0f0c5. |
| Benzofurans |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |