NCT00399022

Brief Summary

Testing the efficacy of the SNRI medication Duloxetine for treating OCD patients who did not respond to SSRI

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 13, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 14, 2006

Completed
Last Updated

January 31, 2008

Status Verified

January 1, 2008

First QC Date

November 13, 2006

Last Update Submit

January 28, 2008

Conditions

OCD

Interventions

DuloxetineDRUG

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • OCD as main diagnosis according to DSM-IV
  • Age 18 to 65
  • Men and women
  • YBOCS score is 18 or more, or 12 or more in case of only obsessions

You may not qualify if:

  • Patients treated with Duloxetine, currently or in the past
  • Patients having comorbid schizophrenia or psychotic disorder or bipolar disorder Patients with substance abuse disorder in the last 6 months Patients who were suicidal or did serious suicide attempt in the last year Pregnant or lactating women, or woman of childbearing potential, which is not using adequate contraception Patients with neurologic disturbance or disorder Patients with serious or imbalanced medical condition Patients with allergic response to SSRI or duloxetine Patients who started new treatment (CBT or pharmacology) in less than 3 months

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chaim Sheba Medical Center

Ramat Gan, 52621, Israel

Location

MeSH Terms

Interventions

Duloxetine Hydrochloride

Intervention Hierarchy (Ancestors)

ThiophenesSulfur CompoundsOrganic ChemicalsHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Joseph Zohar, MD

    Chaim Sheba Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV

Study Record Dates

First Submitted

November 13, 2006

First Posted

November 14, 2006

Last Updated

January 31, 2008

Record last verified: 2008-01

Locations

IL(1)