NCT01368432

Brief Summary

This research is being done to see if a drug called escitalopram (Lexapro) is helpful to people who are suffering from depression after traumatic brain injury (TBI).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
16

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Apr 2010

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
completed

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

April 1, 2010

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

June 3, 2011

Completed
5 days until next milestone

First Posted

Study publicly available on registry

June 8, 2011

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2012

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2013

Completed
3.7 years until next milestone

Results Posted

Study results publicly available

October 24, 2016

Completed
Last Updated

October 24, 2016

Status Verified

August 1, 2016

Enrollment Period

2.7 years

First QC Date

June 3, 2011

Results QC Date

July 13, 2016

Last Update Submit

August 31, 2016

Conditions

TBIMajor DepressionOther Psychiatric Disorders

Keywords

TBIDepressionMoodBehavior

Outcome Measures

Primary Outcomes (2)

  • Montgomery-Asberg Depression Rating Scale (MADRS) at Baseline

    This scale assesses the range of symptoms most frequently observed in patients with major depression. This measure will be used to assess the difference in Montgomery-Asberg Depression Rating Scale (MADRS) at baseline and 12 weeks. The scores range from 0-60. 0 to 6 - normal; 7 to 19 - mild depression; 20 to 34 - moderate depression; \>34 - severe depression. In this study the score was used as a continuous variable.

    MADRS score at baseline

  • Montgomery-Asberg Depression Rating Scale (MADRS)

    This scale assesses the range of symptoms most frequently observed in patients with major depression. This measure will be used to assess the difference in Montgomery-Asberg Depression Rating Scale (MADRS) at baseline and 12 weeks. The scores range from 0-60. 0 to 6 - normal; 7 to 19 - mild depression; 20 to 34 - moderate depression; \>34 - severe depression. In this study the score was used as a continuous variable.

    MADRS score at 12 weeks

Secondary Outcomes (12)

  • Clinical Global Impression (CGI) - Severity at Baseline

    Baseline

  • Clinical Global Impression (CGI)- Improvement

    at 12 weeks

  • Clinical Anxiety Scale (CAS)

    Baseline

  • Clinical Anxiety Scale (CAS)

    12 weeks

  • Satisfaction With Life (SWL)

    baseline

  • +7 more secondary outcomes

Study Arms (2)

Placebo

PLACEBO COMPARATOR

Daily for 12 weeks

Drug: Placebo

Escitalopram

EXPERIMENTAL

Escitalopram 10 mg or 20 mg daily for 12 weeks

Drug: Escitalopram

Interventions

EscitalopramDRUG

Escitalopram 10 mg or 20 mg daily for 12 weeks by mouth

Also known as: Lexapro
Escitalopram
PlaceboDRUG

Sugar pill placebo

Also known as: sugar pill
Placebo

Eligibility Criteria

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

You may qualify if:

  • Closed head injury
  • Fulfill Diagnostic and Statistical Manual Diploma in Social Medicine (DSM) IV criteria "Major Depressive Disorder"
  • years of age or older
  • Able to provide informed consent
  • Stable medical history

You may not qualify if:

  • History of Stroke, Encephalitis, Seizures, or any other pre-TBI neurological diseases
  • History of mental retardation
  • Alcohol or Substance dependence in the last 1 year
  • Inability to undergo MRI scan
  • Pregnancy
  • Current use of any psychotropic medications including any antidepressants, antipsychotics, anxiolytics, or sedative hypnotics
  • Poor response to escitalopram in the past
  • Acutely suicidal or requiring inpatient psychiatric hospitalization, as determined by the study psychiatrist
  • Good medication response to another antidepressant in the past

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Johns Hopkins University

Baltimore, Maryland, 21224, United States

Location

Related Links

MeSH Terms

Conditions

Depressive Disorder, MajorDepressionBehavior

Interventions

EscitalopramSugars

Condition Hierarchy (Ancestors)

Depressive DisorderMood DisordersMental DisordersBehavioral Symptoms

Intervention Hierarchy (Ancestors)

PropylaminesAminesOrganic ChemicalsNitrilesBenzofuransHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsCarbohydrates

Results Point of Contact

Title
Vani Rao
Organization
Johns Hopkins University & school of Medicine
vrao@jhmi.edu
410-550-2288

Study Officials

  • Vani Rao, M.D

    Johns Hopkins University

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

June 3, 2011

First Posted

June 8, 2011

Study Start

April 1, 2010

Primary Completion

December 1, 2012

Study Completion

March 1, 2013

Last Updated

October 24, 2016

Results First Posted

October 24, 2016

Record last verified: 2016-08

Data Sharing

IPD Sharing
Will not share

Locations

US(1)