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PTSDPhase 2/3NCT03216356

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

A Phase 2/3 study testing CBT + ImRs, CBT + I.E. and D-Cycloserine in people with PTSD, run by Boston University Charles River Campus at 1 site in United States.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
PTSD
What is being tested?
CBT + ImRs, CBT + I.E. and D-Cycloserine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
0 participants
Where
1 siteUnited States
Study dates
Sep 2016to Dec 2024
Phase
Phase 2/3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.
Show all 12Show fewer
  • 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.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Center for Anxiety and Related Disorders at Boston University

    Boston, Massachusetts, 02215

Other trials in United States

About this study

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.

Read the detailed description

The primary aim of this proof-of-concept-study is to investigate the utility of d-cycloserine (DCS; a partial N-methyl-D-aspartate receptor agonist) for enhancing the effect of a novel psychosocial intervention, imagery rescripting (ImRs).

ImRs is a therapeutic technique that has shown positive outcomes for people suffering from PTSD and as an adjunct to CBT for PTSD. Patients are asked to recall their memory of a specific traumatic experience, and then to imagine an intervention that changes the course and outcome of the event to produce a more satisfying result. It is hypothesized that reconsolidation of the trauma memory is the mechanism of ImRs. DCS augments exposure therapy but also appears to enhance reconsolidation of memory. We hypothesize that DCS will enhance the effect of ImRs by incorporating safety cues into the trauma memory.

Sixty adults with PTSD symptoms due to a traumatic event at least three months prior to intake will receive 4 sessions of either: CBT + ImRs, or CBT + imaginal exposure (IE). In sessions 2 and 3, participants will be randomized to receive either DCS or placebo (PLA).

We hypothesize that DCS + ImRs sessions will enhance treatment outcome by facilitating reconsolidation of the trauma memories incorporating new safety cues. We also hypothesize that ImRs + PLA will provide equal or better outcomes as the IE + PLA condition.

The primary outcome measure will be improvements in PTSD symptoms, as assessed at baseline, post-treatment and at 1-month follow-up. Secondary outcome measures will be self-report questionnaires assessing depression symptoms, general psychological complaints, sleep quality, quality of life, and PTSD cognitions.

Conditions
PTSD
Being tested
CBT + ImRs, CBT + I.E., D-Cycloserine, Placebo, Study Pill
Medical subject headings
Stress Disorders, Post-Traumatic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CBT + ImRsBehavioural

    Also called Experimental Group

    Cognitive Behavioral Therapy with Imagery Rescripting

  • CBT + I.E.Behavioural

    Also called Active Comparison Group

    Cognitive Behavioral Therapy with Imagery Exposure

  • D-CycloserineDrug

    Also called Experimental Group

    250 mg DCS (derived from Seromycin 250 mg capsules)

  • PlaceboDrug

    Also called Active Comparison Group, Placebo Comparison Group

    polyethylene glycol 3350 powder

  • Study PillDrug

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

Study groups in NCT03216356
Study groupRoleWhat they receive
CBT + ImRs + DCS pillExperimentalThe experimental arm involves cognitive-behavioral therapy, imagery rescripting techniques and d-cycloserine medication (pill).
Receives: Behavioral: CBT + ImRs; Drug: D-Cycloserine
CBT + ImRs + placeboActive comparatorThe active comparator arm involves cognitive behavioral therapy, imagery rescripting techniques and placebo medication (pill).
Receives: Behavioral: CBT + ImRs; Drug: Placebo
CBT + I.E. + study pillActive comparatorThe placebo comparator involves cognitive behavioral therapy, imaginal exposure and study pill (DCS or placebo)
Receives: Behavioral: CBT + I.E.; Drug: Study Pill

What is being measured

The primary outcome is the main question the study is designed to answer.

  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)

    Measured: Change from baseline to 4 weeks (post-treatment)

Secondary outcomes (6)

  1. PTSD Checklist for DSM-5 (PCL-5)

    The PCL-5 is a self-reported measure of PTSD symptom severity. It will also be administered every session during treatment (weeks

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

  2. Depression, Anxiety and Stress Scale (DASS-21)

    The DASS is a self-reported measure of depression, anxiety and stress. It will also be administered before every therapy session.

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

  3. Posttraumatic Cognitions Inventory (PTCI)

    The PTCI measures negative cognitions about the self, the world and self-blame related to trauma. It will also be administered at every therapy session.

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

  4. Pittsburgh Sleep Quality Index (PSQI)

    The PSQI measures various domains of sleep quality over the past month

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

  5. Quality of Life Enjoyment and Satisfaction Questionnaire

    The Q-LES-Q measures various domains of quality of life and life satisfaction

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

  6. The Clinician-Administered PTSD Scale (CAPS) at follow-up

    The CAPS is a semi-structured interview that assesses PTSD symptom severity.

    Measured: Changes from baseline to 5 weeks (1-week follow-up) and 9 weeks (1- month follow-up)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Jul 2017
  2. Study startSep 2016
  3. Primary completionDec 2023 (estimated)
  4. Study completionDec 2024 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2/3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03216356
Sponsor's protocol ID
4114
Status last verified
Feb 2023
First submitted
18 Oct 2016
Last updated
8 Feb 2023
Results posted
No
Data monitoring committee
No
Individual data sharing
Undecided

Publications

  • 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.

    PubMed 10452174

  • 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.

    PubMed 17005868

  • 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.

    PubMed 18005935

  • 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.

    PubMed 23599046

  • 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.

    PubMed 22694905

  • 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.

    PubMed 23524061

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing CBT + ImRs, CBT + I.E. and D-Cycloserine in people with PTSD, run by Boston University Charles River Campus at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: withdrawn, as of the sponsor's last update on 8 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was withdrawn before enrolling participants, so there are no results.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The Clinician-Administered PTSD Scale (CAPS) (time frame: Change from baseline to 4 weeks (post-treatment)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03216356, which also lists 6 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Feb 2023.

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