NCT02601677

Brief Summary

Nucleus accumbens/anterior limb of internal capsule play important roles in the process of treatment-refractory obsessive compulsive disorder, deep brain stimulation of nucleus accumbens/anterior limb of internal capsule will inhibit its activity and thus to effectively prevent the disorder.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
10

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Nov 2015

Typical duration for not_applicable

Status
unknown

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

Study Start

First participant enrolled

November 1, 2015

Completed
7 days until next milestone

First Submitted

Initial submission to the registry

November 8, 2015

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 10, 2015

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2018

Completed
Last Updated

November 10, 2015

Status Verified

November 1, 2015

Enrollment Period

3 years

First QC Date

November 8, 2015

Last Update Submit

November 9, 2015

Conditions

Obsessive Compulsive Disorder

Keywords

Obsessive Compulsive DisorderDeep Brain StimulationNucleus accumbens

Outcome Measures

Primary Outcomes (1)

  • Yale-Brown Obsessive Compulsive Scale (Y-BOCS)

    6 month

Secondary Outcomes (8)

  • Clinical Global Impression (CGI)

    6 month

  • Global assessment of functioning (GAF)

    6 month

  • The Hamilton Anxiety Scale (HAM-A)

    6 month

  • The Hamilton Rating Scale for Depression (HAM-D)

    6 month

  • Sheehan Disability Scale (SDS)

    6 month

  • +3 more secondary outcomes

Study Arms (2)

Deep Brain Stimulation

EXPERIMENTAL

Continuous deep brain stimulation of bilateral nucleus accumbens

Procedure: Deep brain stimulation

Standard Control

ACTIVE COMPARATOR

Fluoxetine

Drug: Fluoxetine

Interventions

Deep brain stimulationPROCEDURE

Deep brain stimulation of bilateral Nucleus accumbens/Anterior Limb of Internal Capsule

Deep Brain Stimulation
FluoxetineDRUG

Fluoxetine is one of selective serotonin reuptake inhibitors(SSRIs).

Standard Control

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Diagnosis of OCD following the diagnostic and statistical manual of mental disorders-fourth edition (DSM-IV) criteria for OCD;
  • Duration of illness: min. 5 year;
  • years old \<Age \<60 years old;
  • Severe form of OCD, as evidenced by: a score≥25 on the Y-BOCS, a score \> 4 on the CGI scale, a score≤40 on the GAF ("global assessment of functioning).
  • All patients were lack of response to drug therapy after adequate administration (defined as more than 12 weeks at the maximum tolerated dose) of at least four different medications, lack of response to CBT (Cognitive Behaviour Therapy)over the course of 1 year of therapy or after 20 sessions.
  • Normal cognitive status and ability to understand and comply with instructions for multiple therapies.
  • Good overall health.

You may not qualify if:

  • Present or past history of psychotic symptoms.
  • Severe personality disorders;
  • Any clinically significant neurological disorder or medical illnesses affect ;
  • brain function, other than motor tics or Gilles de la Tourette syndrome;
  • Patient currently treated with anticoagulant or antiplatelet drug;
  • Patient with contraindication for surgery or anesthesia;
  • Inability to undergo awaked operation;
  • Infection, coagulopathy, significant cardiac or other medical risk factors for surgery;
  • Patient with contraindication for MRI scanning (cardiac pacemaker, pregnancy, metal in body, severe claustrophobia), abnormal brain MRI or serious inter current disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Obsessive-Compulsive Disorder

Interventions

Deep Brain StimulationFluoxetine

Condition Hierarchy (Ancestors)

Anxiety DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Electric Stimulation TherapyTherapeuticsSurgical Procedures, OperativePropylaminesAminesOrganic Chemicals

Central Study Contacts

Guo-dong Gao, M.D.

CONTACT

+86 29 84777435gguodong@fmmu.edu.cn

Xue-lian Wang, M.D.

CONTACT

+86 29 84777284wxlian@fmmu.edu.cn

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Neurosurgery Department

Study Record Dates

First Submitted

November 8, 2015

First Posted

November 10, 2015

Study Start

November 1, 2015

Primary Completion

November 1, 2018

Study Completion

November 1, 2018

Last Updated

November 10, 2015

Record last verified: 2015-11