Fear Conditioned Response in Healthy Subjects and in OCD Patients Pre and Post Treatment With Sertraline.

NCT03068429 | Completed Phase 4 DMC

• 1 other identifier: 0182/11
• Study Type: interventional
• Target: 69
• Locations: 1 country
• Sites: 1

Brief Summary

24 OCD patients and 24 healthy subjects will be submitted to a two-day fear conditioning paradigm during acquisition of functional magnetic resonance imaging (fMRI). OCD patients will be submitted to the paradigm at two timepoints: baseline and 4 weeks after treatment initiation with sertraline up to 200mg/day or maximum tolerated dosage. OCD patients are expected to demonstrate worsened extinction retention compared to healthy subjects at baseline. Sertraline treatment is expected to improve extinction retention compared to baseline and to normalize the brain regions being recruited with the conditioned stimuli presented during the recall phase.

Conditions

Obsessive-Compulsive Disorder

Keywords

obsessive-compulsive disorder; fear conditioning; functional neuroimaging; sertraline

Outcome Measures

Primary Outcomes (3)

• Main behavioral measure (extinction retention index)

  Equation: 100-((MEAN(2 first CS+E during recall)/MAXIMUM(2 last CS+E during extinction))\*100)

  Baseline for both groups (OCD and helthy subjects), change from baseline to 4 weeks after treatment initiation only for intervention group

• Main functional neuroimaging measure

  ventro medial prefrontal cortex (vmPFC) activation during recall phase

  Baseline for both groups (OCD and helthy subjects), change from baseline to 4 weeks after treatment initiation only for intervention group

• Main treatment outcome measure

  Yale Brown Obsessive Compulsive Scale reduction (final score minus initial score)

  Change from baseline to 4 weeks after treatment initiation (only interventional group)

Secondary Outcomes (10)

• Main behavioral measure baseline comparison (extinction retention index OCD patients versus healthy subjects)

  Baseline

• Main functional neuroimaging measure (activation maps for contrast CS+E versus CS-during recall phase,OCD patients versus healthy subjects)

  Baseline (all subjects)

• Secondary behavioral measure (learning- conditioning index, OCD patients pre and post treatment)

  Change from baseline to 4 weeks after treatment initiation (only interventional group)

• Secondary behavioral measure (learning- conditioning index, OCD patients versus healthy subjects)

  Baseline (all subjects)

• Secondary Behavioral Measure (context discrimination index based on skin conductance, OCD patients pre and post treatment)

  Change from baseline to 4 weeks after treatment initiation (only interventional group)

Study Arms (1)

Sertraline open label

EXPERIMENTAL

Sertraline hydrochloride up to 200mg/day or maximum tolerated dosage for 4-weeks.

Drug: Sertraline Hydrochloride

Interventions

Sertraline Hydrochloride DRUG

first week: sertraline hydrochloride 50mg/day, second week: sertraline hydrochloride 100mg/day, third week: sertraline hydrochloride 150mg/day, fourth week: sertraline hydrochloride 200mg/day OBS.: Other SSRIs (fluoxetine, paroxetine, escitalopram) with equivalent dosage schedules can be used if patients report prior intolerance to sertraline

Also known as: sertraline 50mg, zoloft

Sertraline open label

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Healthy controls
• willingness to participate in research
• OCD patients
• willingness to participate in research
• main diagnosis of OCD (psychiatric clinical evaluation)
• minimum YBOCS (Yale Brown Obsessive-compulsive severity scale) score of 16 points

You may not qualify if:

• Healthy controls
• any current psychiatric diagnosis according to evaluation using semi structured interview for DSM IV diagnoses (SCID I)
• any past psychiatric diagnoses except single major depression episode and simple phobia (evaluation by semi structure interview-SCID I)
• current use of psychotropic medications (last use has to be at least 3 months prior to study initiation)
• chronic use of any medications except vitamins and contraceptives
• being pregnant
• OCD patients
• comorbidity with neurodevelopmental disorders (autism, mental retardation), current psychotic disorders, current substance dependence or abuse, bipolar mood disorder according to evaluation using semi structured interview for DSM IV diagnoses (SCID I)
• current use of psychotropic medications (last use has to be at least 3 months prior to study initiation)
• being pregnant or at risk of becoming pregnant

Sponsors & Collaborators

• University of Sao Paulo: lead

Study Sites (1)

Institute of Psychiatry, Hospital das Clínicas, Faculdade de Medicina da Universidade de São Paulo

São Paulo, 05403-010, Brazil

Location

MeSH Terms

Conditions

Obsessive-Compulsive Disorder

Interventions

Sertraline

Condition Hierarchy (Ancestors)

Anxiety Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

1-Naphthylamine; Amines; Organic Chemicals; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Polycyclic Compounds

Study Officials

• Juliana B Diniz, MD, PhD

  Researcher

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Psychiatrist, principal investigator

Model Details: 4-weeks open label trial of sertraline up to 200mg/day treatment for obsessive compulsive disorder

Study Record Dates

• First Submitted: February 22, 2017
• First Posted: March 1, 2017
• Study Start: December 1, 2016
• Primary Completion: December 20, 2019
• Study Completion: July 31, 2020
• Last Updated: April 27, 2021

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: SAP, ANALYTIC CODE
• Time Frame: Data is estimated to be available at study completion. Completion date is estimated to be july/2020.
• Access Criteria: There will be no restrictions to acess of unindentified data results.

Locations

BR (1)