Cognitive Behavioral Therapy Versus Sertraline in the Treatment of Post-Traumatic Stress Disorder

NCT00391430 | Terminated Phase 4 Results FDA Drug

• 2 other identifiers: P50MH058911DATR A3-NSC
• Study Type: interventional
• Target: 39
• Locations: 1 country
• Sites: 1

Brief Summary

This study will evaluate which parts of the brain are affected by treatment with behavioral therapy versus medication therapy in people with post-traumatic stress disorder.

Conditions

Post-Traumatic Stress Disorder

Keywords

PTSD; Trauma; Sexual Abuse; Sexual Assault

Outcome Measures

Primary Outcomes (2)

• Salivary Cortisol Levels (Measured Before, During, and After the fMRI)

  Salivary cortisol levels (measured before, during, and after the fMRI)

  Measured 3 days before and after treatment and 1 day during fMRI

• Fear Response (Measured During the fMRI)

  Fear response (measured during the fMRI) in response to positive fearful and neutral stimuli

  Measured on 1 day during two MRIs

Secondary Outcomes (20)

• Trauma History Inventory (THI)

  Measured 30 minutes before and after treatment

• Clinician-Administered PTSD Scale for DSM-IV (CAPS)

  Measured 30 minutes before and after treatment

• Structured Clinical Interview for DSM-IV I and II (SCID I and II)

  Measured 1 hour before and after treatment

• Panic Disorder Severity Scale (PDSS)

  Measured 15 minutes before and after treatment

• Clinical Global Impressions Severity Scale

  Measured weekly throughout the study

Study Arms (3)

Control

NO INTERVENTION

Participants assigned to the control condition will receive no treatment

Sertraline

ACTIVE COMPARATOR

Participants will receive treatment with sertraline

Drug: Sertraline

CBT

ACTIVE COMPARATOR

Participants will receive cognitive behavioral therapy

Behavioral: Cognitive behavioral therapy (CBT)

Interventions

Sertraline DRUG

Dosage: up to 100 mg/day; Frequency: once per day; Duration: 12 weeks

Sertraline

Cognitive behavioral therapy (CBT) BEHAVIORAL

CBT consists of sixteen 1-hour sessions during a period of 12 weeks.

CBT

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• For people with PTSD:
• Meets DSM-IV criteria for PTSD
• Medically healthy
• Right handed
• Learned English prior to age 5
• Agrees to use an effective form of contraception throughout the study
• For healthy controls:
• Medically healthy
• Right handed
• Has experienced a qualifying traumatic event
• Does not meet DSM-IV criteria for present or past PTSD
• Learned English prior to age 5
• Agrees to use an effective form of contraception throughout the study

You may not qualify if:

• For people with PTSD:
• Meets DSM-IV criteria for panic disorder within 6 months prior to study entry
• Current suicide risk
• History of DSM-IV diagnosis of any the following conditions: schizophrenia, bipolar mood disorder, obsessive compulsive disorder (including trichotillomania), or eating disorder
• Meets DSM-IV criteria for substance use or dependence within the 6 months prior to study entry
• Any substance abuse within 2 weeks prior to study entry
• Score of greater than 22 on the 17-item Hamilton Rating Scale for Depression (HAM-D) with depressive symptoms secondary to PTSD
• Current participation in cognitive behavioral psychotherapy that is specifically designed to treat PTSD
• Concomitant psychoactive medications
• History of cerebrovascular accident (CVA) or any disorder that causes chronic neurological problems
• Medical illness with central nervous system (CNS) involvement or currently taking medication that affects the CNS
• Unstable general medical illness requiring intervention (e.g., HIV infection)
• Pregnant, breastfeeding, or plans to become pregnant
• Presence of internal metallic objects, such as heart pacemaker, shrapnel, bullets, surgical prostheses, surgical clips, or pins
• History of gastric bypass surgery

Sponsors & Collaborators

• NYU Langone Health: lead
• National Institute of Mental Health (NIMH): collaborator

Study Sites (1)

NYU Institute for Trauma & Resilience

New York, New York, 10016, United States

Location

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic; Wounds and Injuries

Interventions

Sertraline; Cognitive Behavioral Therapy

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

1-Naphthylamine; Amines; Organic Chemicals; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Polycyclic Compounds; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Results Point of Contact

• Title: Marylene Cloitre
• Organization: NYU Langone

marylene.cloitre@nyulangone.org

2122632471

Study Officials

• Marylene Cloitre, PhD

  NYU

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 20, 2006
• First Posted: October 24, 2006
• Study Start: May 1, 2005
• Primary Completion: July 1, 2009
• Study Completion: July 1, 2009
• Last Updated: July 21, 2021
• Results First Posted: July 21, 2021

Record last verified: 2021-06

Locations

US (1)