Treatment of Post-Traumatic Brain Injury (TBI) Depression

NCT00233103 | Completed Phase 2 Results DMC

• 2 other identifiers: GCO 02-0677H133A020501
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 1

Brief Summary

Randomized clinical trial of sertraline vs. placebo for post-TBI depression

Conditions

Depression

Keywords

Sertraline; TBI; depression; SSRI; brain injury

Outcome Measures

Primary Outcomes (2)

• Depression at Baseline

  The 17-item Hamilton Rating Scale for Depression (HAM-D) is a widely used clinician-rated measurement of depression severity. A score of 0-7 is considered to be normal. 8-13 = mild depression, 14-18 = moderate depression, 19-22 = severe depression, and ≥ 23 = very severe depression. Self-report of depression and DSM-IV diagnosis (HAM-D score) at baseline.

  baseline

• Depression at End of Treatment

  Self-report of depression and Diagnostic and Statistical Manual Diploma in Social Medicine (DSM-IV) diagnosis (HAM-D score) compared at end of treatment to baseline. Participants were considered treatment responders if their initial HAM-D decreased by 50% or dropped below a score of 10 at the end of the intervention. The 17-item Hamilton Rating Scale for Depression (HAM-D) is a widely used clinician-rated measurement of depression severity. A score of 0-7 is considered to be normal. 8-13 = mild depression, 14-18 = moderate depression, 19-22 = severe depression, and ≥ 23 = very severe depression.

  end of treatment, average of 10 weeks

Secondary Outcomes (2)

• BAI

  Immediately post-intervention

• Life-3

  Immediately post-intervention at 10 weeks

Study Arms (2)

Sertraline

EXPERIMENTAL

Daily oral sertraline in doses starting at 25mg and increasing to therapeutic levels (up to 200mg).

Drug: Sertraline

Placebo

PLACEBO COMPARATOR

Placebo for 10 weeks.

Drug: Placebo

Interventions

Sertraline DRUG

Sertraline arm

Sertraline

Placebo DRUG

Placebo

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years or older
• experienced a TBI with a documented loss of consciousness or other evidence of a TBI (i.e., evidence of pathology on neuro-imaging)
• at least 6 months post-injury
• English-speaking
• residential telephone service
• living within 1.5 hours of New York City
• able to comprehend or answer verbal or written questionnaires
• willing to provide consent to participate in a 12 week drug study to treat Major Depressive Disorder (MDD); current MDD as diagnosed using Structured Clinical Interview for Diagnostic and Statistical Manual Diploma in Social Medicine (DSM) Disorders (SCID), and severity of MDD rated at least 18 on the HAM-D.

You may not qualify if:

• currently taking antidepressant medication (including monamine oxidase inhibitors (MOAs) or tricyclic antidepressants (TCAs)
• unwilling to abstain from seeking new psychosocial or pharmacologic treatments during the course of the study
• currently in psychotherapy
• active suicidal plans and/or requiring hospitalization
• prior use of sertraline
• currently experiencing other serious medical illness
• currently pregnant or breast feeding
• mass brain lesions or other neurological diagnoses other than TBI
• history of current or past psychosis or mania
• current substance abuse
• history of clinically significant liver or renal disease

Sponsors & Collaborators

• Icahn School of Medicine at Mount Sinai: lead
• U.S. Department of Education: collaborator

Study Sites (1)

Icahn School of Medicine at Mount Sinai

New York, New York, 10029, United States

Location

Related Publications (1)

• Ashman TA, Cantor JB, Gordon WA, Spielman L, Flanagan S, Ginsberg A, Engmann C, Egan M, Ambrose F, Greenwald B. A randomized controlled trial of sertraline for the treatment of depression in persons with traumatic brain injury. Arch Phys Med Rehabil. 2009 May;90(5):733-40. doi: 10.1016/j.apmr.2008.11.005.

  PMID: 19406291 DERIVED

MeSH Terms

Conditions

Depression; Brain Injuries

Interventions

Sertraline

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries

Intervention Hierarchy (Ancestors)

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

Limitations and Caveats

Sample size was small - those who dropped out could have reduced the differential effect. Sample was heterogeneous for severity and time since injury.

Results Point of Contact

• Title: Wayne A Gordon, PhD
• Organization: Icahn School of Medicine at Mount Sinai

wayne.gordon@mssm.edu

212-659-9372

Study Officials

• Wayne Gordon, Ph.D.

  Icahn School of Medicine at Mount Sinai

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 3, 2005
• First Posted: October 5, 2005
• Study Start: June 1, 2003
• Primary Completion: September 1, 2008
• Study Completion: September 1, 2008
• Last Updated: November 13, 2015
• Results First Posted: November 13, 2015

Record last verified: 2015-10

Locations

US (1)