Judith Cohen, MD
Medical Director, Center for Traumatic Stress in Children & Adolescents
Allegheny General Hospital
Professor of Psychiatry
Drexel University College of Medicine
Dr. Cohen discusses how children experience PTSD and effective treatments.
This study will test the hypothesis of whether an antagonist at the corticotropin releasing factor type 1 receptor (i.e. GSK561679) is superior to placebo in reducing symptoms of PTSD. The study is being conducted at 2 sites in the United States: a site at Emory University, and one at Mount Sinai School of Medicine. About 150 women outpatients aged 21 to 65 who currently suffer from PTSD will be enrolled. Study participation could last for up to about 12 weeks.
1. Women between the ages of 21 and 65
2. Fulfills DSM-IV criteria for a primary diagnosis of Post-traumatic stress disorder (PTSD)
3. Duration of PTSD is at least 3 months
4. Able to read and speak English
5. For women of reproductive age, must use of an effective birth control method or abstinence for the duration
6. Clinician-administered PTSD Scale score at Screening and Randomization visits of ≥ 50 on the CAPS
7. For women who have a history of peptic ulcer disease (PUD) with known etiology, evidence of effective treatment was provided with full eradication of ulcers and symptoms must be provided.
1. Lifetime diagnosis of a psychotic disorder (including schizophrenia), disorder, bipolar disorder, or obsessive compulsive disorder.
2. Current or past month participation in another clinical trial in which she is or will be exposed to an investigational or non-investigational drug or device.
3. A current significant unstable medical illness or organic brain impairment, including stroke, CNS tumor, demyelinating disease, cardiac, pulmonary, gastrointestinal, renal or hepatic impairment that would likely interfere with the action, absorption, distribution, metabolism, or excretion of GSK561679.
4. Patients who in the investigator’s judgment pose a current suicidal or homicidal risk
5. Substance abuse or dependence within the past 90 days, or testing positive for illegal substances.
6. Current diagnosis of anorexia or bulimia nervosa.
7. A documented history of hepato-biliary disease including evidence of current hepatitis infection, or clinically significant hepatic enzyme elevation including any one of the following enzymes greater than 1.5 times the upper limit of normal (ULN) value (ALT, AST, ALP, total or direct bil > 1.5 x ULN, unless consistent with presumed or diagnosed Gilbert’s disease
8. Taking systemic corticosteroids within 2 weeks of the Randomization Visit
9. Treatment with any other psychoactive medication within 2 weeks of Screening visit, including psychoactive herbal or nutritional treatment.
10. Likely need for more than 2 weeks of regular NSAID use or any use of aspirin.
11. Taking any medication with with a narrow therapeutic index, that are metabolized via the cytochrome P450 3A4 or 2C9 pathway (e.g. warfarin), or transported via OATP1B1 or P-gp, within 2 weeks (or 5 half-lives, whichever is longer) prior to the Randomization Visit.
12. Taking any products that are potent inducers or inhibitors of the cytochrome P450 3A4 pathway for 2 weeks (or 5 half lives, whichever is longer) prior to the Randomization Visit.
13. Stool positive for occult blood.
14. Pregnancy or lactation*
15. Participants who, in the opinion of the investigator, would be noncompliant with the visit schedule or study procedures (e.g. illiteracy, planned vacations, or planned hospitalizations during the study).
16. Previous treatment with CRF1 receptor antagonist
17. Any laboratory abnormality that in the investigator’s judgment is considered to be clinically significant (e.g. blood pressure, ECG, TSH, LFT, etc.)
18. Patients who are receiving exposure-based psychotherapy that targets PTSD symptoms
19. Current or planned litigation or other actions related to secondary gain regarding the traumatic event
Richard A. Bryant, PhD
Director, Traumatic Stress Clinic
Scientia Professor of Psychology, University of New South Wales
Dr. Bryant talks about the intersection of traumatic brain injury (TBI) and PTSD, including treatment and how therapy needs to be adapted for TBI survivors.
This study uses functional magnetic resonance imaging (fMRI) to learn how the brain functions in adolescents receiving fluoxetine (Prozac) or cognitive behavioral therapy (CBT) for anxiety or depression in children/adolescents. All participants will receive interviews to assess how they are doing in general, including his or her general mood, degree of nervousness and behavior. Each participant and one of his or her parents will be interviewed separately and together.
Age: 8 to 17
Consent: Can give consent/assent. (Parents will provide consent; minors will provide assent.)
IQ: All subjects will have IQ greater than 70 (Assessment relies on WASI)
SUBJECTS WITH AN ANXIETY DISORDER
Diagnosis: Current Diagnosis of Social Phobia, Separation Anxiety, or Generalized Anxiety Disorder (Based on K-SADS)
Symptom Severity: Score greater than 9 on PARS (This score was used to enroll subjects in previous trial demonstrating efficacy of an SSRI in pediatric anxiety.)
Clinical Impairment: CGAS less than 60
SUBJECTS WITH A MOOD DISORDER
Diagnosis: Current Diagnosis of Major Depression (Based on K-SADS (juveniles) or SCID (adults))
Clinical Impairment: CGAS less than 60 (juveniles) GAS less than 70 (adults)
Symptom Severity: CDRS Score greater than 39 (juveniles) (This score was used to enroll subjects in previous trials demonstrating efficacy of an SSRI in pediatric depression.)
Consent: Can give consent/assent.
IQ: All subjects will have IQ greater than 70. Assessment relies on WASI.
Any serious medical condition or condition that interferes with fMRI scanning, and for patients electing medication, any condition that increases risk of SSRI treatment. All patients will have complete physical examination. Healthy volunteer participants will be medication-free and have no current serious medical conditions, based on a review of their medical history.
Current use of any psychoactive substance; current suicidal ideation; current diagnosis of attention deficit hyperactivity disorder (ADHD) of sufficient severity to require pharmacotherapy. These factors could complicate treatment with an SSRI. No subject on medication will be accepted into the trial. Subjects will not be taken off of medications to enter the trial.
Current diagnoses: Tourette's, OCD, posttraumatic distress disorder, conduct disorder. These factors may be effected by SSRI treatment, influencing ability to detect effects on anxiety/depression
Past or current history of mania, psychosis, or pervasive developmental disorder. These factors may be effected by SSRI treatment, influencing ability to detect effects on anxiety/depression
Recent use of an SSRI: All subjects must have been free of any SSRI use for at least one month (fluoxetine six months) and must not have been treated with an SSRI for their current depressive episode. This is designed to exclude subjects who have failed a trial of an SSRI for their current episode of major depression.
HEALTHY ADULT SUBJECTS
Any current psychiatric diagnosis. Assessment relies on SCID.
SUBJECTS WITH AN ANXIETY DISORDER
Current Major Depressive Disorder
The human brain goes through a complex process to form and consolidate memories. But is it possible to replace memories of fearful events, and in doing so, assist in the treatment of patients suffering from the debilitating effects of posttraumatic stress disorder or other anxiety disorders?
Dr. Joseph LeDoux and a team of New York University neuroscientists think they have found a way to replace traumatic memories through therapy.
Video from the series Speaking of Science, National Institute of Mental Health (NIMH)
The primary aim of this study is to compare the effectiveness of two lifestyle interventions for improving the outcome of prolonged exposure therapy (PE) for PTSD. Eligible participants will receive free PE for 12 weeks and participate in either a wellness or exercise program (determined by a flip of a coin).