Department of Defense PTSD Adaptive Platform Trial - Master Protocol

A Phase 2, Multi-center, Multi-arm, Randomized, Placebo-controlled, Double-blind, Adaptive Platform Study to Evaluate the Safety, Tolerability, and Efficacy of Potential Pharmacotherapeutic Interventions in Active-Duty Service Members, Veterans, and Non-Veteran Civilians With PTSD

This is a Phase 2 randomized, double-blinded, placebo-controlled study that will evaluate multiple potential pharmacotherapeutic interventions for PTSD utilizing an adaptive platform trial design. Participants are randomized among the available cohorts in the study and the resulting randomization enables sharing/pooling of control participants, where all interventions may be compared to a common control (placebo). The master protocol describes the default procedures and analyses for all cohorts; treatment-specific eligibility requirements, safety and efficacy procedures, or endpoints are described in the cohort-specific appendices and reflected in the intervention-specific clinicaltrials.gov records.

Study Overview

• Status: Recruiting
• Conditions: Post Traumatic Stress Disorder
• Intervention / Treatment: Drug: Intervention A Placebo; Drug: Intervention B Placebo; Drug: Intervention C Daridorexant; Drug: Intervention C Placebo; Drug: Intervention B Vilazodone Hydrochloride (HCl); Drug: Intervention A Fluoxetine Hydrochloride (HCl); Drug: Intervention D Placebo; Drug: Intervention D SLS-002

Detailed Description

The general structure of the M-PACT consists of a 30-day Screening Period, a 12-week Treatment Period, and a 4-week Safety Follow-up. The trial will include up to 5 open cohorts (it is possible for 1 of the cohorts to begin sooner than the others, as necessary). Importantly, the integration of multi-modal biomarker assessments within the M-PACT allows for defining future cohorts based on to be determined biomarker signatures in a multi stage approach. Initial testing in non biomarker defined cohorts will be referred to as "main stage" testing, while testing in biomarker-defined cohorts will occur within "biomarker extensions."

Initially designed as up to 5-arms versus control, the adaptive platform trial will continue enrollment until decisions are made to stop all cohorts. Interim analyses will be conducted at approximately quarterly intervals, beginning after at least 40 participants have been randomized and at least 10 participants have completed the End of Study (EOS) visit. At each interim analyses, unblinded data will be reviewed by an independent, firewalled ISAC and a DSMB. The possible cohort-level decisions that could be made by the prespecified adaptive plan include stopping enrollment to a cohort for futility, stopping enrollment to a cohort for anticipated success, or stopping enrollment to a cohort for reaching the maximum sample size. For cohort-specific interventions intending to pursue a labeling claim (which will be clearly stated in the cohort-specific appendix before cohort initiation), early stopping for success will not be considered. New cohorts for investigation can be added at any time. The DSMB may recommend stopping any cohort for safety reasons.

Candidate biomarker data will be retrospectively analyzed after each cohort has completed main stage testing, and cohort testing may be re-initiated for prospective evaluation of the treatment in a participant population enriched (e.g., either only biomarker "positive" or only biomarker "negative" participants would be enrolled) or stratified based on biomarker status. In addition, candidate biomarkers (which may also be characterized or validated externally to the M-PACT) may be used to stratify randomization across cohorts or as a prospective enrichment strategy at the initiation of a cohort. Exploratory biomarker data will be evaluated throughout the trial to identify additional candidate biomarkers for testing within the M-PACT.

For information specific to each intervention included in this platform trial, please refer to the below corresponding, separate, clinicaltrials.gov records:

Vilazodone NCT05948579; Fluoxetine NCT05948553; Daridorexant NCT05948540; SLS-002 NCT06816433.

Parties interested in having their intervention considered for testing within the M-PACT should email partners@gcaresearch.org

• Study Type: Interventional
• Enrollment (Estimated): 800
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Please visit the website:; Phone Number: ptsdclinicaltrial.org; Email: info@gcaresearch.org

Study Locations

• United States
  • Florida
    • Miami, Florida, United States, 33032
      • Recruiting
      • Homestead Associates in Research, Inc.
      • Contact: Homestead Associates Research Contact; Phone Number: 305-246-0873; Email: info@associatesinresearch.com
  • Georgia
    • Atlanta, Georgia, United States, 30318
      • Recruiting
      • Advanced Discovery Research
      • Contact: Advanced Discovery Research Contact; Phone Number: 470-777-8839; Email: contact@advdiscovery.com
  • Hawaii
    • Tripler AMC, Hawaii, United States, 96859
      • Recruiting
      • Tripler Army Medical Center (TAMC)
      • Contact: Department of Clinical Investigation; Phone Number: 808-304-1143; Email: dha.tripler.tripler-amc.mbx.ci-study@health.mil
  • Kentucky
    • Fort Thomas, Kentucky, United States, 41075
      • Recruiting
      • Cincinnati Veteran's Affairs Medical Center
      • Contact: Jada Turner; Phone Number: 513-485-8934; Email: Jada.Turner@va.gov
  • Maryland
    • Bethesda, Maryland, United States, 20889-5632
      • Recruiting
      • Walter Reed National Military Medical Center (WRNMC)
      • Contact: Amber Hampton, MSN; Phone Number: 301-295-2397; Email: amber.hampton.ctr@usuhs.edu
      • Contact: Payton Flores, MPH; Phone Number: 301-295-9144; Email: payton.flores.ctr@usuhs.edu
      • Principal Investigator: Aaron Wolfgang, MD
  • New York
    • Williamsville, New York, United States, 14221
      • Recruiting
      • Upstate Clinical Research Associates, LLC
      • Contact: Amy Strombach; Phone Number: (716) 626-6320; Email: amy.strombach@outlook.com
  • Texas
    • San Antonio, Texas, United States, 78236
      • Recruiting
      • Wilford Hall Ambulatory Surgical Center (WHASC)
      • Contact: Laura Liu, Clinical Coordinator II, BS, RN, CCRC; Phone Number: 301-295-3790; Email: laura.liu.ctr@usuhs.edu
      • Principal Investigator: Paul Sherman, MD
      • Sub-Investigator: Derrek Hamaoka, MD
  • Virginia
    • Fort Belvoir, Virginia, United States, 22060-5285
      • Recruiting
      • Alexander T. Augusta Military Medical Center (ATAMMC):
      • Contact: Wafa Azgugu, Study Coordinator; Phone Number: 571-231-1315; Email: wafa.azgugu.ctr@usuhs.edu
      • Contact: Aamina Khattak, Research Assistant; Phone Number: 571-231-1314; Email: aamina.khattak.ctr@usuhs.edu
  • Washington
    • Joint Base Lewis McChord, Washington, United States, 98433
      • Recruiting
      • Madigan Army Medical Center
      • Contact: Madigan Army Medical Center Contact; Phone Number: 253-968-4263; Email: nathan.t.kearns.civ@health.mil

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria: An individual must meet all the following criteria to be eligible to participate in this study:

1. Is willing and able to provide written informed consent.
2. ≥18 and <65 years of age at Screening.
3. Meets DSM-5 criteria for PTSD according to CAPS-5-R, Past Month assessment at Screening and Baseline.
4. The index trauma must have occurred more than 3 months prior to Screening.
5. Has a CAPS-5-R, Past Month total score of ≥26 at Screening and Baseline. Note: The CAPS-5 scoring grid will be used to score answers and to calculate the total score to determine eligibility.
6. Participants must be able to read, speak, and understand English sufficiently to complete the CAPS-5, which is the primary efficacy endpoint and is administered by trained Centralized Assessors.

7. Agrees to consistently use an acceptable method of birth control (required for both males and females who are of reproductive potential and sexually active with partners of the opposite sex) throughout the duration of participants' involvement in the study and for a minimum of 30 days after the last dose of study intervention or longer, as specified in the assigned cohort-specific appendices.

   1. For females of reproductive potential, acceptable birth control methods are defined as: hormonal contraceptives, intrauterine device, or double barrier contraception (ie, male condom and diaphragm, male condom or diaphragm with spermicidal gel or foam). Hormonal contraceptives must have been started at least 2 months prior to the Baseline Visit. In addition, agrees to no egg donation or harvesting for the duration of the study and for at least 30 days after the last dose of study intervention or as specified in the assigned cohort-specific appendices.
   2. Non-reproductive potential for females is defined by a post-menopausal (12 consecutive months without menses or surgically sterile). If in question, an FSH of >40 U/mL, per central laboratory testing must be documented. Surgical sterility (hysterectomy, bilateral oophorectomy, or bilateral tubal ligation) must be documented.
   3. Females of reproductive potential must have a negative pregnancy test at the Screening (serum) Visit and Baseline (urine) Visit.
   4. For males, adequate birth control methods will be defined as the use of double barrier contraception (e.g., male condom and diaphragm, male condom or diaphragm with spermicidal gel or foam). In addition, male participants must agree not to donate sperm for the duration of the study and for at least 30 days after the last dose of study intervention or as specified in the assigned cohort-specific appendices.
   5. Non-reproductive potential for males is defined as surgical sterility (i.e., vasectomy) at least 3 months prior to Baseline.
8. Is able and willing to participate in study assessments and undergo blood draws.
9. For participants who consent to the optional MRI: willingness to undergo MRI, e.g., is not claustrophobic, and has no contraindications to MRI.

Exclusion Criteria: An individual who meets any of the following criteria will not be eligible to participate in this trial:

1. Is pregnant or breastfeeding at the Screening or Baseline Visits or planning pregnancy during the study.

2. Is at risk for suicide based on any of the following:

   1. Had any suicidal ideation or behavior (including preparatory behavior) that required psychiatric hospitalization in the 3 months prior to screening.
   2. Had more than 2 actual suicide attempts within the last 3 years, not including interrupted or aborted attempts, preparatory acts or behaviors, or non-suicidal self injurious behavior (as per C SSRS response).
   3. Has any history of suicidal ideation and/or intent following initiation of a medication used for psychiatric symptoms or disorders.
   4. Has any history of suicide-related hospitalization following initiation of a medication used for psychiatric symptoms or disorders.
3. Is taking any prohibited medication or cohort-specific restrictions (see cohort-specific appendices), is unable/unwilling to discontinue medications, or in the PI's judgment, cannot discontinue medications. Participants must agree to a washout period of at least 14 days or 5 half-lives, whichever is longer, prior to the first dose of study intervention. Note, the half-life of the parent drug (not metabolites) should be used in this calculation.
4. In the 3 months prior to the Baseline Visit, has initiated or terminated individual or group PTSD specific psychotherapy (e.g., Eye Movement Desensitization & Reprocessing, Prolonged Exposure, Cognitive Processing Therapy, Stress Inoculation Training, Present Centered Therapy), or therapy is anticipated to conclude during the study. Completion of ≤2 sessions in the prior 3 months with no plans to continue is not exclusionary. Participants in stable trauma-focused or non-trauma-focused therapy must agree to continue treatment for the duration of participation in the study.
5. Has undergone or plans to undergo sex reassignment surgery. Note: participants who are currently undergoing stable hormone replacement therapy are eligible for inclusion in the study.
6. Meets DSM-5 (American Psychiatric Association 2013) criteria for moderate or severe AUD or other SUDs, including cannabis, hallucinogens, inhalants, opioids, sedatives, hypnotics, anxiolytics, or stimulants within 3 months of screening. Nicotine use disorder is allowed.

7. Has a positive screen for illicit drugs (excluding cannabis) or positive alcohol screen (either positive on qualitative test or above .04% on a quantitative test) at the Baseline Visit.

   1. If the urine drug screen is positive at Screening (excluding cannabis), the participant will not immediately be excluded from participation in the study. The urine drug screen must be repeated at Baseline after at least 7 days since the initial test. If the urine drug screen is positive at Baseline (excluding cannabis), then the participant will be discontinued from the study.
   2. If the urine alcohol screen is positive at Screening, the participant will not immediately be excluded from participation in the study. If the urine alcohol screen is also positive at Baseline, then the participant will be discontinued from the study.
8. Has a lifetime history or current symptoms of psychotic features, as determined by the MINI Psychotic Disorders and Mood Disorders with Psychotic Features screening questions.
9. Has a history of neoplastic disease or completion of treatment in the last 5 years, except for treated basal cell or squamous cell carcinoma of the skin.

10. Has any clinically significant abnormal findings on the 12-lead ECG at the Screening Visit or Baseline Visit, such as:

    1. Abnormal heart rhythm (such as atrial fibrillation, ventricular fibrillation, or torsade de pointes)
    2. ECG with a QTc interval >450 msec for males or >470 msec for females (QT interval corrected with Fridericia correction [QTcF]) At Screening, eligibility will be based on the central ECG reading. At Baseline, eligibility will be based on the local ECG reading by a site investigator.

11. Has abnormal laboratory results at the Screening Visit:

    1. serum creatinine >1.5 mg/dL OR
    2. estimated creatinine clearance of <50 mL/min calculated by the Cockcroft and Gault formula.

12. Has clinically significant abnormal laboratory results at the Screening Visit that indicate impaired liver function:

    1. ALT or AST >2 × ULN
    2. total bilirubin level >1.5 × ULN (unless previously known Gilbert syndrome)
    3. prolonged prothrombin time >1.5 × ULN
13. Has a prior history of drug induced liver injury characterized by ALT or AST >3 × ULN AND total bilirubin level >2 × ULN without cholestasis (ie, ALP <2 × ULN).
14. Has any other clinically significant laboratory result at Screening that could impact the participant's safety or participation in the study, as determined by the Site PI.
15. Has any other concurrent psychiatric or medical condition that would impact the participant's safety, ability to appropriately complete evaluations, or participation in the study, as determined by the Site PI.
16. Does not have a stable method of contact over the duration of the study.

17. Has participated in any interventional clinical trial or treatment with any investigational drug or other investigational intervention within 3 months or 5 half-lives, whichever is longer, of screening.

    Note: Previous participation in an observational study within 3 months of screening is permitted.

    Note: Participants who are enrolled in the M-PACT, and who are eligible for re randomization, are permitted to remain in the study and receive alternative cohort intervention following a 14-day or 5 half-lives washout period, whichever is longer. The half-life of the parent drug (not metabolites) should be used in this calculation.

18. Is unavailable for the duration of the trial, unlikely to be compliant with the protocol, or deemed by the Site PI to be unsuitable for participation in the trial for any reason.
19. Systolic blood pressure >140 mm Hg and/or diastolic blood pressure >90 mm Hg or Systolic blood pressure <90 mm Hg and/or diastolic blood pressure <50 mm Hg.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

8

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention A: Fluoxetine HCl	Drug: Intervention A Fluoxetine Hydrochloride (HCl); Fluoxetine will be administered at 10 to 60 mg daily. The initial dose for all participants will be 10 mg daily for 1 week, then increased to 20 mg daily for 2 weeks, then increased to 40 mg daily for 2 weeks, then increased to 60 mg daily for the remainder of the trial. One reduction in dose due to tolerability will be allowed. When a participant's dose is decreased due to tolerability, the dose will not be increased.
Placebo Comparator: Intervention A Placebo	Drug: Intervention A Placebo; A matching placebo will be administered at 10 to 60 mg daily in the same regimen as the intervention.
Placebo Comparator: Intervention B Placebo	Drug: Intervention B Placebo; A matching placebo will be administered at 10 to 40 mg daily in the same regimen as the intervention.
Experimental: Intervention C Daridorexant	Drug: Intervention C Daridorexant; Daridorexant will be administered 50 mg once daily.
Placebo Comparator: Intervention C Placebo	Drug: Intervention C Placebo; A matching placebo will be administered at 50 mg daily in the same regimen as the intervention.
Experimental: Intervention D SLS-002	Drug: Intervention D SLS-002; • SLS-002 will be administered via intranasal administration (one spray per nostril, per device) at 78 mg two times per week for the first eight weeks and then once a week for the last four weeks.
Placebo Comparator: Intervention D Placebo	Drug: Intervention D Placebo; A matching placebo will be administered via intranasal administration (one spray per nostril, per device) two times per week for the first eight weeks and then once a week for the last four weeks.
Experimental: Intervention B Vilazodone HCl	Drug: Intervention B Vilazodone Hydrochloride (HCl); Vilazodone HCl will be administered at 10 mg once daily for 7 days, followed by 20 mg for 7 days, followed by 40 mg for the remainder of the trial. There must be a minimum of 7 days between dosage increases. One reduction in dose due to tolerability will be allowed. After Week 8, dose reduction for tolerability is allowed, but dose increase is not allowed.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of new or worsening suicidal thoughts or behaviors as measured by change in Columbia Suicide Severity Rating Scale (C-SSRS) score from baseline.	The C-SSRS is an assessment of suicidal ideation and behavior in clinical and research settings. The C-SSRS consists of 16 questions that ask about suicidal ideation and behaviors (the first 10 questions comprise the ideation subscale and the last 6 comprise the behavior subscale). This 5-item subscale ranges from a minimum of 0 (corresponding to no suicidal ideation) to a maximum of 5 (representing active suicidal ideation with plan and intent).	12 Weeks
Absolute change in the Clinician-Administered PTSD Scale-5-Revised (CAPS-5-R) Past Month total score at Week 12 (Final/Early termination Visit).	A change in PTSD symptom severity from baseline as measured by CAPS-5-R Past Month. The range of the scale is 0-200. The higher the score at baseline, the worse the PTSD severity. The larger the decrease in score from baseline, the better the outcome.	12 Weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Frequency of treatment-emergent adverse events (TEAEs).	The TEAEs recorded during the study will be summarized by system organ class, preferred term, and treatment group. Adverse events and medical history will be coded using the most current version of MedDRA.	12 Weeks
Severity of treatment-emergent adverse events (TEAEs).	The TEAEs recorded during the study will be summarized by system organ class, preferred term, and treatment group. Adverse events and medical history will be coded using the most current version of MedDRA.	12 Weeks
Frequency of serious adverse events (SAEs)	The SAEs recorded during the study will be summarized by system organ class, preferred term, and treatment group. Adverse events and medical history will be coded using the most current version of MedDRA.	12 Weeks
Severity of serious adverse events (SAEs).	The SAEs recorded during the study will be summarized by system organ class, preferred term, and treatment group. Adverse events and medical history will be coded using the most current version of MedDRA.	12 Weeks
Relative change from Baseline to Week 12 in the Clinician-Administered PTSD Scale for DSM-5 Revised (CAPS-5-R), Past Month total score.	A relative change in PTSD symptom severity from baseline as measured by CAPS-5-R Past Month. The range of the scale is 0-200. The higher the score at baseline, the worse the PTSD severity. The larger the decrease in score from baseline, the better the outcome.	12 Weeks
Number of participants with a Response Rate ≥30%	≥30% reduction from Baseline to 12 Weeks in the Clinician-Administered PTSD Scale for DSM-5 Revised (CAPS-5-R), Past Month total score. The range of the scale is 0-200. The higher the score, the worse the PTSD severity. The larger the decrease in score from baseline, the better the outcome.	12 Weeks
Number of participants with a Response Rate ≥50%	≥50% reduction from Baseline to 12 Weeks in the Clinician-Administered PTSD Scale for DSM-5 Revised (CAPS-5-R), Past Month total score. The range of the scale is 0-200. The higher the score, the worse the PTSD severity. The larger the decrease in score from baseline, the better the outcome.	12 Weeks
Number of participants Achieving Remission	Achieving remission: defined as the Clinician-Administered PTSD Scale for DSM-5 Revised (CAPS-5-R), Past Month total score <18. The range of the scale is 0-200. The higher the score, the worse the PTSD severity.	12 Weeks
Relative and absolute change from Baseline in Clinician-Administered PTSD Scale for DSM-5 Revised (CAPS-5-R), Past Month total score at Weeks 4 and 8	A relative change in PTSD symptom severity from baseline as measured by CAPS-5-R Past Month. The range of the scale is 0-200. The higher the score at baseline, the worse the PTSD severity. The larger the decrease in score from baseline, the better the outcome.	8 weeks
Absolute change from Baseline at each post-Baseline Visit in GAD-7 questionnaire	Generalized anxiety disorder screener (GAD-7) Scale range: 0 to 21 Interpretation: Higher scores indicate worse anxiety symptoms	Week 1 (Baseline), Week 4, Week 6, Week 8, Week 12
Absolute change from Baseline at each post-Baseline Visit in TLFB for substance use	Timeline Follow Back (TLFB) for Substance Use Scale range: Quantitative daily use (no fixed total range) Interpretation: Higher values indicate greater substance use (worse outcome)	Week 1 (Baseline), Week 4, Week 6, Week 8, Week 12
Absolute change from Baseline at each post-Baseline Visit in FTND questionnaire	Fagerström Test for Nicotine Dependence (FTND) Scale range: 0 to 10 Interpretation: Higher scores indicate greater nicotine dependence (worse outcome)	Week 1 (Baseline), Week 4, Week 6, Week 8, Week 12
Absolute change from Baseline at each post-Baseline Visit in B-IPF questionnaire	Brief Inventory of Psychosocial Functioning (B-IPF) Scale range: 0 to 40 Interpretation: Higher scores indicate worse psychosocial functioning (worse outcome)	Week 1 (Baseline), Week 4, Week 6, Week 8, Week 12
Absolute change from Baseline at each post-Baseline Visit in WHOQOL-BREF	World Health Organization Quality of Life - BREF (WHOQOL-BREF) Scale range: 0 to 100 Interpretation: Higher scores indicate better quality of life (better outcome)	Week 1 (Baseline), Week 12
Absolute change from Baseline at each post-Baseline Visit in PSS questionnaire	Perceived Stress Scale (PSS) Scale range: 0 to 40 Interpretation: Higher scores indicate greater perceived stress (worse outcome)	Week 1 (Baseline), Week 4, Week 6, Week 8, Week 12
Absolute change from Baseline at each post-Baseline Visit in BPI	Brief Pain Inventory (BPI) Scale range: 0 to 10 (pain severity and interference) Interpretation: Higher scores indicate worse pain severity and interference (worse outcome)	Week 1 (Baseline), Week 12
Absolute change from Baseline in IDSIQ (7-day mean scores prior to visits)	Insomnia Daytime Symptoms and Impacts Questionnaire (IDSIQ) Scale range: 0 to 100 Interpretation: Higher scores indicate worse daytime impairment due to insomnia (worse outcome)	Week 0 (Screening), Week 1 (Baseline), Week 4, Week 8, Week 12, Week 16 (Safety Follow-Up)

Collaborators and Investigators

• Sponsor: Global Coalition for Adaptive Research
• Collaborators: Idorsia Pharmaceuticals Ltd.; U.S. Army Medical Research and Development Command; Berry Consultants; Cambridge Cognition Ltd; Citeline; PPD Development, LP

Publications and helpful links

General Publications

• Viele K. Allocation in platform trials to maintain comparability across time and eligibility. Stat Med. 2023 Jul 20;42(16):2811-2818. doi: 10.1002/sim.9750. Epub 2023 Apr 23.

Study record dates

Study Major Dates

• Study Start (Actual): November 2, 2023
• Primary Completion (Estimated): July 1, 2028
• Study Completion (Estimated): July 1, 2029

Study Registration Dates

• First Submitted: June 13, 2022
• First Submitted That Met QC Criteria: June 13, 2022
• First Posted (Actual): June 16, 2022

Study Record Updates

• Last Update Posted (Actual): June 5, 2026
• Last Update Submitted That Met QC Criteria: June 2, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Trauma and Stressor Related Disorders; Mental Disorders; Stress Disorders, Traumatic; Stress Disorders, Post-Traumatic; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Neurotransmitter Agents; Membrane Transport Modulators; Psychotropic Drugs; Cytochrome P-450 Enzyme Inhibitors; Neurotransmitter Uptake Inhibitors; Antidepressive Agents; Serotonin Agents; Selective Serotonin Reuptake Inhibitors; Antidepressive Agents, Second-Generation; Cytochrome P-450 CYP2D6 Inhibitors; Serotonin Receptor Agonists; Serotonin 5-HT1 Receptor Agonists; Vilazodone Hydrochloride; Fluoxetine
• Other Study ID Numbers: S-21-02 / IND 157676

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No