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Neurocircuit Mechanisms of OCD Across the Lifespan

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ClinicalTrials.gov Identifier: NCT02437773
Recruitment Status : Recruiting
First Posted : May 8, 2015
Last Update Posted : January 15, 2019
Sponsor:
Information provided by (Responsible Party):
Kate D. Fitzgerald, University of Michigan

Tracking Information
First Submitted Date  ICMJE May 2, 2015
First Posted Date  ICMJE May 8, 2015
Last Update Posted Date January 15, 2019
Study Start Date  ICMJE September 2014
Estimated Primary Completion Date July 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 5, 2015)
Brain activity as assessed by Magnetic Resonance Imaging (fMRI) scans [ Time Frame: Baseline to 12-weeks ]
fMRI BOLD signal response of posterior medial frontal cortex (pMFC), ventral medial prefrontal cortex (vmPFC) and anterior insula (aIns) during performance monitoring. This signal will be measured as BOLD contrast estimates for errors compared to correct trials based on average signal in a priori defined regions of interest for pMFC, vmPFC and aIns. The investigators are looking for increases in pMFC activation in adolescents from pre- to post-treatment. In contrast, the investigators are looking for increases in inverse connectivity (resting state and during task) between vmPFC and aIns in adults from pre- to post-treatment.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02437773 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: May 5, 2015)
OCD symptom severity measured by the Yale Brown Obsessive Compulsive Scale for adults or the Child Yale Brown Obsessive Compulsive Scale for adolescents. [ Time Frame: Baseline to 12-weeks ]
OCD symptom severity measured by the Yale Brown Obsessive Compulsive Scale for adults and the Child Yale Brown Obsessive Compulsive Scale for adolescents. This scale is administered by an independent assessor to rate OCD symptom severity on a scale of 0 to 40, with 40 being most severe. The investigators are looking for decreases in OCD severity ratings from pre- to post-treatment.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Neurocircuit Mechanisms of OCD Across the Lifespan
Official Title  ICMJE Neurocircuit Mechanisms of OCD Across the Lifespan
Brief Summary

Obsessive-compulsive disorder (OCD), characterized by intrusive thoughts (obsessions) and related behavioral rituals (compulsions), is a common psychiatric illness that often emerges in childhood and causes life-long disability in over 50% of patients. Psychological theory suggests that OCD symptoms are driven by a person's difficulty disengaging their feelings from simple tasks (e.g. washing hands, locking a door) due to excessive anxiety about performance errors. Cognitive behavioral therapy (CBT), the gold standard treatment for OCD, repeatedly exposes patients to their OCD-stressor until this anxiety is reduced. While CBT is typically more effective in teenagers than adults, patients from both age groups are usually left with residual symptoms, highlighting the need for better treatments. In this study, CBT will be studied in both teen-aged and adult patients. Two groups, both with childhood onset OCD, will be randomized to either CBT for OCD or stress management training (SMT), an active therapy but with minimal effects on OCD symptoms. The investigators will also study age-matched, healthy controls as comparison subjects.

Before and after 12 weeks of CBT, all subjects will undergo functional Magnetic Resonance Imaging (fMRI) scans to see what regions of the brain become active when a concentration task is performed and how that activation is changed after CBT. The purpose of this study is to demonstrate the brain changes associated with CBT treatment and how differences in these changes in teenage compared to adult patients may drive differences in CBT response.

Detailed Description While the study itself is of parallel design for its data-collection and measurement purpose, it is listed as a partial-crossover design in the IRB-approved protocol because subjects randomized to the SMT group are given the option of entering 12-weeks of CBT sessions after all of their SMT data collection. To understand brain changes that occur with CBT compared to SMT in both age groups, the investigators will collect fMRI data before and after therapy. Some limited data will be collected in patients who are initially randomized to SMT but then opt to crossover to CBT. fMRI data will also be collected in healthy teens and adults before and after 12 weeks (but without intervening therapy) to allow the investigators to control for the simple effects of time that may cause brain changes that are not related to therapy.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Obsessive-Compulsive Disorder
Intervention  ICMJE
  • Behavioral: Cognitive Behavioral Therapy - Adolescents
    A therapy which gradually yet repeatedly exposes adolescent patients to their obsessive compulsive-relevant "error" cues during a task performance until their anxiety habituates.
    Other Name: CBT
  • Behavioral: Stress Management Therapy - Adolescents
    An active control therapy with minimal effects on OCD symptoms.
    Other Name: SMT
  • Behavioral: Optional CBT - Adolescents
    This is the cross-over element for those that completed the SMT treatment group and opt to have the OCD treatment.
    Other Name: CBT
  • Behavioral: Cognitive Behavioral Therapy - Adults
    A therapy which gradually yet repeatedly exposes adult patients to their obsessive compulsive-relevant "error" cues during a task performance until their anxiety habituates.
    Other Name: CBT
  • Behavioral: Stress Management Therapy - Adults
    An active control therapy with minimal effects on OCD symptoms.
    Other Name: SMT
  • Behavioral: Optional CBT - Adults
    This is the cross-over element for those that completed the SMT treatment group and opt to have the OCD treatment.
    Other Name: CBT
  • Other: fMRI only - Healthy Control Adults
    Two fMRI's only, scheduled at 12-weeks apart. This is for Healthy Control Adults and is used only as a means for observation, NOT as an intervention to be studied.
  • Other: fMRI only - Healthy Control Adolescents
    Two fMRI's only, scheduled at 12-weeks apart. This is for Healthy Control Adolescents and is used only as a means for observation, NOT as an intervention to be studied.
Study Arms  ICMJE
  • Active Comparator: Cognitive Behavioral Therapy - Adolescents
    12 Cognitive-Behavioral Therapy sessions scheduled weekly over a 12-week period.
    Intervention: Behavioral: Cognitive Behavioral Therapy - Adolescents
  • Stress Management Therapy - Adolescents

    12 SMT sessions scheduled weekly over a 12-week period.

    After study completion, the OCD subjects who received SMT may derive benefit for non-OCD anxiety symptoms. They will be offered a 12-week course of CBT with a study therapist to directly target OCD symptoms (i.e., a partial cross-over).

    Interventions:
    • Behavioral: Stress Management Therapy - Adolescents
    • Behavioral: Optional CBT - Adolescents
  • Active Comparator: Cognitive Behavioral Therapy - Adults
    12 CBT sessions scheduled weekly over a 12-week period.
    Intervention: Behavioral: Cognitive Behavioral Therapy - Adults
  • Stress Management Therapy - Adults

    12 SMT sessions scheduled weekly over a 12-week period.

    After study completion, the OCD subjects who received SMT may derive benefit for non-OCD anxiety symptoms. They will be offered a 12-week course of CBT with a study therapist to directly target OCD symptoms (i.e., a partial cross-over).

    Interventions:
    • Behavioral: Stress Management Therapy - Adults
    • Behavioral: Optional CBT - Adults
  • Healthy Control - Adolescents
    Healthy control adolescents matched to gender, race and socioeconomic status (SES) with adolescent patients with OCD will be enrolled. These healthy adolescents will be scanned with fMRI before and after 12 weeks, but without any intervention (i.e., no therapy).
    Intervention: Other: fMRI only - Healthy Control Adolescents
  • Healthy Control - Adults
    Healthy control adults matched to gender, race and socioeconomic status (SES) with adult patients with OCD will be enrolled. These healthy adults will be scanned with fMRI before and after 12 weeks, but without any intervention (i.e., no therapy).
    Intervention: Other: fMRI only - Healthy Control Adults
  • Optional CBT - Adolescents
    OCD adolescent participants who were randomized to the SMT and have completed all study procedures will be offered an additional 12 weeks of Optional Cognitive-Behavioral Therapy.
    Intervention: Behavioral: Optional CBT - Adolescents
  • Optional CBT - Adults
    OCD adult participants who were randomized to the SMT and have completed all study procedures will be offered an additional 12 weeks of Optional Cognitive-Behavioral Therapy.
    Intervention: Behavioral: Optional CBT - Adults
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: May 5, 2015)
220
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE July 2019
Estimated Primary Completion Date July 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria for all OCD Subjects & Healthy Volunteers:

  • Male or female
  • Age 13-17 (inclusive) subjects diagnosed with OCD, age of onset before 15 years
  • Age 25-45 (inclusive) subjects diagnosed with OCD, age of onset before 15 years
  • Age 13-17 (inclusive) year old healthy volunteers
  • Age 25-45 (inclusive) year old healthy volunteers
  • OCD adolescent and adult subjects can be on medications but will have to be on a stable medication regimen for at least 4 weeks prior to enrolling.
  • Able and willing to give informed consent
  • Ability to tolerate small, enclosed spaces without anxiety

Exclusion Criteria for OCD Subjects:

  • Anyone between the ages of 18-24 (inclusive range)
  • No lifetime diagnosis of bipolar or psychosis disorders
  • Age of OCD onset after 15 years old
  • No substance/alcohol abuse in the past 6 months
  • No lifetime history of substance/alcohol dependence
  • No evidence of suicidal intentions or behaviors in the past 6 months
  • No history of serious medical or neurological illness
  • No history of closed head injury (e.g. loss of consciousness)
  • Pregnant or trying to become pregnant

Additional Exclusion Criteria for Healthy Volunteers:

  • No history of past or current mental illness
  • Not taking any medication, prescription or non-prescription, with psychotropic effects
  • First-degree family members with OCD or tic disorders
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 13 Years to 45 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Eunice Kim 734-232-0443 Psych-OCD-Study@med.umich.edu
Contact: Laura Stchur, MSW 734-936-1323 Psych-OCD-Study@med.umich.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02437773
Other Study ID Numbers  ICMJE HUM00091368
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Kate D. Fitzgerald, University of Michigan
Study Sponsor  ICMJE University of Michigan
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Kate Fitzgerald, MD University of Michigan, Dept of Psychiatry
PRS Account University of Michigan
Verification Date January 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP