Effect of D-cycloserine on a Short Imagery Rescripting Intervention for Subclinical PTSD

NCT03216356 | Withdrawn Phase 2

• 1 other identifier: 4114
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

This study aims to investigate the utility of d-cycloserine (DCS) for enhancing the effect of a novel psychosocial intervention, imagery rescripting (ImRs), in adults with mild to moderate PTSD symptoms after experiencing a traumatic event such as sexual or physical assault, serious accident, etc. Participants will receive 4 sessions of either cognitive behavioral therapy with imagery rescripting or cognitive behavioral therapy with imaginal exposure and will receive study medication (DCS or Pill placebo) prior to Session 2 and Session 3.

Conditions

PTSD

Outcome Measures

Primary Outcomes (1)

• The Clinician-Administered PTSD Scale (CAPS)

  The CAPS is a semi-structured interview that assesses PTSD symptom severity. It will also be administered at 1-week and 4-week follow up (see secondary outcomes)

  Change from baseline to 4 weeks (post-treatment)

Secondary Outcomes (6)

• PTSD Checklist for DSM-5 (PCL-5)

  Change from baseline to 4 weeks (post-treatment), 5 weeks (1-week follow-up) and 9 weeks (1- month follow-up)

• Depression, Anxiety and Stress Scale (DASS-21)

  Change from baseline to 4 weeks (post-treatment), 5 weeks (1-week follow-up) and 9 weeks (1- month follow-up)

• Posttraumatic Cognitions Inventory (PTCI)

  Change from baseline to 4 weeks (post-treatment), 5 weeks (1-week follow-up) and 9 weeks (1- month follow-up)

• Pittsburgh Sleep Quality Index (PSQI)

  Change from baseline to 4 weeks (post-treatment), 5 weeks (1-week follow-up) and 9 weeks (1-month follow-up)

• Quality of Life Enjoyment and Satisfaction Questionnaire

  Change from baseline to 4 weeks (post-treatment), 5 weeks (1-week follow-up) and 9 weeks (1-month follow-up)

Study Arms (3)

CBT + ImRs + DCS pill

EXPERIMENTAL

The experimental arm involves cognitive-behavioral therapy, imagery rescripting techniques and d-cycloserine medication (pill).

Behavioral: CBT + ImRs; Drug: D-Cycloserine

CBT + ImRs + placebo

ACTIVE COMPARATOR

The active comparator arm involves cognitive behavioral therapy, imagery rescripting techniques and placebo medication (pill).

Behavioral: CBT + ImRs; Drug: Placebo

CBT + I.E. + study pill

ACTIVE COMPARATOR

The placebo comparator involves cognitive behavioral therapy, imaginal exposure and study pill (DCS or placebo)

Behavioral: CBT + I.E.; Drug: Study Pill

Interventions

CBT + ImRs BEHAVIORAL

Cognitive Behavioral Therapy with Imagery Rescripting

Also known as: Experimental Group

CBT + ImRs + DCS pill; CBT + ImRs + placebo

CBT + I.E. BEHAVIORAL

Cognitive Behavioral Therapy with Imagery Exposure

Also known as: Active Comparison Group

CBT + I.E. + study pill

D-Cycloserine DRUG

250 mg DCS (derived from Seromycin 250 mg capsules)

Also known as: Experimental Group

CBT + ImRs + DCS pill

Placebo DRUG

polyethylene glycol 3350 powder

Also known as: Active Comparison Group, Placebo Comparison Group

CBT + ImRs + placebo

Study Pill DRUG

250 mg DCS (derived from Seromycin 250 mg capsules) or polyethylene glycol 3350 powder

CBT + I.E. + study pill

Eligibility Criteria

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

You may qualify if:

• Adult outpatients ≥ 18 years of age, who have experienced a traumatic event such as sexual assault, physical assualt, a serious accident, or other event where they feared for their life or their safety, at least 3 months prior to intake, with a primary subclinical psychiatric diagnosis of post-traumatic stress disorder (PTSD) as measured by the CAPS-5 (structured clinical interview to assess for PTSD according to the DSM-5). Eligible participants will have a CAPS-5 score of mild or moderate.
• Physical examination and laboratory findings within normal limits, as determined by the study nurse.
• Willingness and ability to participate in the informed consent process and comply with the requirements of the study protocol.
• Potential subjects must have sufficient command of the English language.

You may not qualify if:

• A lifetime history of bipolar disorder, schizophrenia, psychosis, delusional disorders or organic brain syndrome; past history of reported or current seizures; use of Isoniazid (a particular antibiotic); cognitive dysfunction that can interfere with capacity to engage in therapy;
• A history of substance or alcohol dependence (other than nicotine) in the last 6 months (or otherwise unable to commit to refraining from alcohol use during the acute period of study participation). The acute period of study participation is defined as during their visit and 24 hours before and after their visit.
• Patients with significant suicidal ideation or who have enacted suicidal behaviors within 6 months prior to intake will be excluded from study participation and referred for appropriate clinical intervention.
• Patients cannot be taking psychotropic medication during the study period. They have to be off psychotropic medication for three weeks.
• Participating in ongoing exposure-based psychotherapy for PTSD or psychodynamic therapy focusing on exploring specific, dynamic causes of the traumatic symptomatology and providing management skills. General supportive therapy initiated \> 3 months prior to study is acceptable.
• Significant personality dysfunction likely to interfere with study participation. For example, overly aggressive behavior or disruptive behavior that might jeopardize safety of the staff or impairs providing the treatment.
• Serious medical illness or instability for which hospitalization may be likely within the next year. For example, if people are currently in a treatment for cancer, or people that are waiting for organ donation. This decision would be determined by our medical staff during the eligibility screen.
• Patients with a current or past history of epilepsy or seizures.
• Patients who have experienced any cardiac event. Patients with clinically significant abnormalities in vital signs (e.g., systolic blood pressure \>150 mm Hg or diastolic blood pressure \>100 mm Hg) at screening will be excluded from further study participation and referred for appropriate clinical management.
• Pregnant women, lactating women, women who are breastfeeding and women of childbearing potential who are not using medically accepted forms of contraception (e.g., IUD, oral contraceptives, or implanted progesterone rods stabilized for at least 3 months).
• Patients with a history of head trauma causing loss of consciousness, or ongoing cognitive impairment.
• Patients who experienced multiple events of interpersonal trauma prior to the age of 14.

Sponsors & Collaborators

• Boston University Charles River Campus: lead
• James S McDonnell Foundation: collaborator

Study Sites (1)

Center for Anxiety and Related Disorders at Boston University

Boston, Massachusetts, 02215, United States

Location

Related Publications (6)

• Arntz A, Weertman A. Treatment of childhood memories: theory and practice. Behav Res Ther. 1999 Aug;37(8):715-40. doi: 10.1016/s0005-7967(98)00173-9.

  PMID: 10452174 BACKGROUND

• Lee JL, Milton AL, Everitt BJ. Reconsolidation and extinction of conditioned fear: inhibition and potentiation. J Neurosci. 2006 Sep 27;26(39):10051-6. doi: 10.1523/JNEUROSCI.2466-06.2006.

  PMID: 17005868 BACKGROUND

• Arntz A, Tiesema M, Kindt M. Treatment of PTSD: a comparison of imaginal exposure with and without imagery rescripting. J Behav Ther Exp Psychiatry. 2007 Dec;38(4):345-70. doi: 10.1016/j.jbtep.2007.10.006. Epub 2007 Oct 26.

  PMID: 18005935 BACKGROUND

• Hofmann SG, Smits JA, Rosenfield D, Simon N, Otto MW, Meuret AE, Marques L, Fang A, Tart C, Pollack MH. D-Cycloserine as an augmentation strategy with cognitive-behavioral therapy for social anxiety disorder. Am J Psychiatry. 2013 Jul;170(7):751-8. doi: 10.1176/appi.ajp.2013.12070974.

  PMID: 23599046 BACKGROUND

• Litz BT, Salters-Pedneault K, Steenkamp MM, Hermos JA, Bryant RA, Otto MW, Hofmann SG. A randomized placebo-controlled trial of D-cycloserine and exposure therapy for posttraumatic stress disorder. J Psychiatr Res. 2012 Sep;46(9):1184-90. doi: 10.1016/j.jpsychires.2012.05.006. Epub 2012 Jun 12.

  PMID: 22694905 BACKGROUND

• Arntz A, Sofi D, van Breukelen G. Imagery Rescripting as treatment for complicated PTSD in refugees: a multiple baseline case series study. Behav Res Ther. 2013 Jun;51(6):274-83. doi: 10.1016/j.brat.2013.02.009. Epub 2013 Mar 6.

  PMID: 23524061 BACKGROUND

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic

Interventions

Cycloserine

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Isoxazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Oxazolidinones; Oxazoles; Serine; Amino Acids, Neutral; Amino Acids; Amino Acids, Peptides, and Proteins

Study Officials

• Joseph K Carpenter, M.A.

  Boston University

  STUDY CHAIR

• Megan Pinaire, B.S.

  Boston Universtiy

  STUDY CHAIR

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: Professor of Psychology

Study Record Dates

• First Submitted: October 18, 2016
• First Posted: July 13, 2017
• Study Start: September 1, 2016
• Primary Completion: December 1, 2023
• Study Completion: December 1, 2024
• Last Updated: February 8, 2023

Record last verified: 2023-02

Locations

US (1)