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Trial record 37 of 513 for:    ESCITALOPRAM AND Serotonin Uptake

Predicting Treatment Response in Patients With OCD

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ClinicalTrials.gov Identifier: NCT03993535
Recruitment Status : Recruiting
First Posted : June 20, 2019
Last Update Posted : July 1, 2019
Sponsor:
Collaborators:
University of Stellenbosch
Columbia University
National Institute of Mental Health and Neuro Sciences, India
VU University Medical Center
Information provided by (Responsible Party):
Roseli Gedanke Shavitt, University of Sao Paulo

Brief Summary:
This study consists of a naturalistic follow-up of subjects with Obsessive-Compulsive Disorder (OCD) that have participated in a global study investigating brain signatures of OCD funded by the National Institutes of Mental Health (RO1MH113250), with the following participant sites: the US (Columbia University, PI: Helen Blair Simpson), Brazil (University of Sao Paulo, PIs: Euripedes Miguel and Roseli G Shavitt), India (National Institutes of Mental Health, PI: Janardhan Reddy), The Netherlands (VU Amsterdam Medical Center, PI: Odile van den Heuvel), and South Africa (University of Cape Town, PI: Dan Stein; Stellenbosch University, PI: Christine Lochner). In this cross-sectional study, two-hundred and fifty unmedicated subjects with OCD (50 per site) will be assessed for clinical, neurocognitive and neuroimaging data. After completion of this study, participants willing to receive evidence-based treatments for OCD will be treated with the available resources in each site and will be assessed for treatment response status periodically, with a final assessment after 1 year of naturalistic follow-up. At this point, we will investigate baseline clinical, neurocognitive and neuroimaging variables associated with the treatment response status.

Condition or disease Intervention/treatment Phase
Obsessive-Compulsive Disorder Drug: selective serotonin reuptake inhibitor Phase 4

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Intervention Model: Single Group Assignment
Intervention Model Description: 12-month naturalistic follow-up of open treatment with evidence-based pharmacologic agents (SSRIs) or cognitive-behavioral therapy (CBT) for OCD
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Clinical, Neurocognitive and Neuroimaging Variables Associated With Response to Treatment in Patients With OCD
Actual Study Start Date : October 10, 2018
Estimated Primary Completion Date : December 21, 2021
Estimated Study Completion Date : December 21, 2021

Resource links provided by the National Library of Medicine

Drug Information available for: Serotonin

Arm Intervention/treatment
SSRI or cognitive behavioral therapy
selective serotonin reuptake inhibitors (fluoxetine, sertraline, citalopram, escitalopram, paroxetine or fluvoxamine) or cognitive-behavioral therapy, depending on availability and patient preference
Drug: selective serotonin reuptake inhibitor
open treatment based on patient preference and treatment availability
Other Name: CBT




Primary Outcome Measures :
  1. response status [ Time Frame: 12 months ]
    severity of OCD as measured by the Yale-Brown Obsessive-Compulsive Scale. The final score of this scale is a sum of 10 items, ranging from 0 to 40. The higher the score, the more severe the clinical picture. The ten items refer to ten questions, five regarding obsessions and five regarding compulsions. The questions assess time, distress, interference, resistance and control over the symptoms. Each question can be rated from 0 (= none) to 4 (most severe).

  2. level of improvement [ Time Frame: 12 months ]
    measured by the Clinical Global Impression Scale - severity and improvement subscales. The severity subscale can be rated from 1 to 7, a higher score corresponding to more severe symptoms. The improvement subscale can also be rated from 1 to 7, a greater score corresponding to lesser improvement. Scores are given individually to each subscale, in absolute numbers (1 to 7)



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Principal DSM-5 diagnosis of OCD
  • Y-BOCS ≥ 16
  • No psychotropic meds for the last 6 weeks, with the exception of PRN sleeping meds (e.g., zolpidem or trazodone up to 50 mg) and benzos, as long as not within the past week or during study participation
  • No CBT/EXRP focused on OCD within the past 6 weeks
  • Capable of providing informed consent

Exclusion Criteria:

  • Lifetime diagnosis of psychotic disorder, bipolar disorder, anorexia nervosa, autism spectrum disorder with IQ < 80, Tourette Disorder
  • Current chronic tic disorder (current = in the past 12 months)
  • Current substance-related and addictive disorders, including nicotine (current = in the past 12 months)
  • Current binge-eating disorder or bulimia (current = in the past 12 months)
  • Acute risk of suicide
  • Female who is pregnant
  • Major medical or neurological problems (including head injury with loss of consciousness) Presence of metallic devices or dental braces
  • IQ < 80
  • Cigarette use: more than 5 per day
  • Alcohol use: more than 2 drinks per day for women and more than 3 drinks per day for men, Marijuana use: more than once per week

Information from the National Library of Medicine

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): NCT03993535


Contacts
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Contact: Roseli G Shavitt, MD, PhD +5511999318626 roseligshavitt@gmail.com
Contact: Daniel LC Costa, MD, PhD +5511972100082 danielcosta228@gmail.com

Locations
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United States, New York
Center for OCD and Related Disorders, New York State Psychiatric Institute/Columbia University Medical Center Not yet recruiting
New York, New York, United States, 10032
Contact: Rachel Middleton, BA    646-774-8138    Rachel.middleton@nyspi.columbia.edu   
Brazil
Institute of Psychiatry - Hospital of Clinics - University of São Paulo Recruiting
São Paulo, Brazil, 05403-000
Contact: Euripedes C Miguel, MD, PhD    551126617594    ecmiguel@usp.br   
Principal Investigator: Roseli G Shavitt, MD, PhD         
India
OCD Clinic, Department of Psychiatry, National Institute of Mental Health and Neurosciences (NIMHANS) Recruiting
Bangalore, India, 560029
Contact: YC Janardhan Reddy, MD, DPM    +9108026995278    ycjreddy@gmail.com   
Contact: Janardhanan Narayanaswamy, MD    +9108026995837    jcn.nimhans@gmail.com   
South Africa
Faculty of Medicine and Health Sciences, Department of Psychiatry, Stellenbosch University Recruiting
Cape Town, South Africa, 7505
Contact: Christine Lochner, PhD    27 21 938 9179    cl2@sun.ac.za   
Contact: Dan Stein, MD, PhD    27 21 938 9165    dan.stein@uct.ac.za   
Sponsors and Collaborators
University of Sao Paulo
University of Stellenbosch
Columbia University
National Institute of Mental Health and Neuro Sciences, India
VU University Medical Center
Investigators
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Principal Investigator: Roseli G Shavitt, MD, PhD University of Sao Paulo

Publications:

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Responsible Party: Roseli Gedanke Shavitt, Director, Obsessive-Compulsive Spectrum Disorders Program, Institute of Psychiatry, Hospital of Clinics, University of Sao Paulo School of Medicine, University of Sao Paulo
ClinicalTrials.gov Identifier: NCT03993535     History of Changes
Other Study ID Numbers: 68743617800000068
First Posted: June 20, 2019    Key Record Dates
Last Update Posted: July 1, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

Keywords provided by Roseli Gedanke Shavitt, University of Sao Paulo:
obsessive-compulsive disorder
predictors
neuroimaging

Additional relevant MeSH terms:
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Serotonin
Serotonin Uptake Inhibitors
Serotonin Receptor Agonists
Serotonin Agents
Neurotransmitter Uptake Inhibitors
Compulsive Personality Disorder
Obsessive-Compulsive Disorder
Personality Disorders
Mental Disorders
Anxiety Disorders
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Membrane Transport Modulators