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NCT Number: NCT06809595

A Phase 3 Trial of MM120 for Generalized Anxiety Disorder (Panorama)

A Phase 3, Double-blind, Placebo-controlled Study (Part A) with an Open-label Extension (Part B) Evaluating DT120 Compared to Placebo in Generalized Anxiety Disorder - Panorama

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Key information

Conditions

Generalized Anxiety Disorder Anxiety Disorders Mental Disorders

Age range

18 year–74 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

A-shine s.r.o., Pilsen, Czechia

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About this study

The study will enroll up to 375 participants aged 18 to 74 years, inclusive with a Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) confirmed primary diagnosis of GAD and a minimum HAM A total score of at least 20 at Screening and Baseline without clinically relevant medical or psychiatric history.

The study consists of a 12-week randomized, double-blind, single-dose administration period evaluating DT120 versus placebo, followed by a 40-week extension phase with the opportunity for open-label treatment. During this phase, participants will be monitored and evaluated for potential treatment with DT120 based on pre-specified safety and symptom severity criteria.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Diagnosis of GAD per DSM-5
  • Male or female aged 18 to 74
  • HAM-A Total Score ≥20

Exclusion criteria

  • Certain psychiatric disorders (other than generalized anxiety disorder)
  • First degree relative with or lifetime history of a psychotic disorder or bipolar disorder
  • Current diagnosis of alcohol or substance use disorder (excluding nicotine and caffeine)
  • Any clinically significant unstable illness

Treatment and study plan

Placebo

Other

A substance that is designed to have no therapeutic value

DT120

Drug

A psychoactive substance that mediates effects mainly through an agonist activity in the serotonin 2A receptor (5-HT2A)

Other names: MM120, lysergide tartrate, LSD D-Tartrate

Primary outcomes

  1. Change from Baseline in Hamilton Anxiety Rating Scale (HAM-A) total score at Week 12

    Time frame: Baseline to Week 12

    The HAM-A consists of the following 14 items that encompass both psychological and somatic symptoms of anxiety. Each item is scored on a scale of 0 (not present) to 4 (severe), with a total score range of 0-56, where <17 indicates mild severity, 18-24 mild to moderate severity and 25-30 moderate to severe.

Secondary outcomes

  1. Change from Baseline in HAM-A total score at Week 8, Week 4, Week 2, and Week 1

    Time frame: Week 8, Week 4, Week 2, and Week 1

    The HAM-A consists of the following 14 items that encompass both psychological and somatic symptoms of anxiety. Each item is scored on a scale of 0 (not present) to 4 (severe), with a total score range of 0-56, where <17 indicates mild severity, 18-24 mild to moderate severity and 25-30 moderate to severe.

  2. HAM-A response (reduction from Baseline score of ≥50%) at each timepoint assessed during the 12-week double-blind period

    Time frame: Baseline to Week 12

    The HAM-A consists of the following 14 items that encompass both psychological and somatic symptoms of anxiety. Each item is scored on a scale of 0 (not present) to 4 (severe), with a total score range of 0-56, where <17 indicates mild severity, 18-24 mild to moderate severity and 25-30 moderate to severe.

  3. HAM-A remission (total score ≤7) at each timepoint assessed during the 12-week double-blind treatment period

    Time frame: Baseline to Week 12

    The HAM-A consists of the following 14 items that encompass both psychological and somatic symptoms of anxiety. Each item is scored on a scale of 0 (not present) to 4 (severe), with a total score range of 0-56, where <17 indicates mild severity, 18-24 mild to moderate severity and 25-30 moderate to severe.

  4. Clinical Global Impression - Improvement (CGI-I) Scale score at each timepoint assessed during the 12-week double-blind period

    Time frame: Day 2 to Week 12

    The CGI-I scale is used to measure the clinician's assessment of how much the participant's illness has improved or worsened relative to Baseline (Visit 2). The CGI-I comprises one item with 7 possible ratings (1-7 points), where a lower score indicates improvement, and a higher score indicates worsening.

  5. Change from Baseline throughout the 12-week double-blind period at each timepoint assessed in Clinical Global Impression - Severity (CGI-S) Scale score

    Time frame: Baseline to Week 12

    The CGI-S scale assesses the clinician's impression of the participant's current severity of illness relative to the clinician's experience with patients who have the same diagnosis. The CGI-S comprises one item with 7 possible ratings (1-7 points), where a higher score indicates more severe illness.

  6. Change from Baseline throughout the 12-week double-blind period at each timepoint assessed in Patient Global Impression - Severity (PGI-S) Scale score

    Time frame: Baseline to Week 12

    The PGI scale is the patient-reported outcome (PRO) counterpart to the CGI scale. The PGI-S comprises one participant-completed item with 5 possible ratings (1-5) where a higher score indicates more severe illness.

  7. Change from Baseline throughout the 12-week double-blind period at each timepoint assessed in - Montgomery-Åsberg Depression Rating Scale (MADRS) total score

    Time frame: Baseline to Week 12

    The MADRS is used to assess depression severity and to detect changes due to antidepressant treatment. The MADRS includes 10 clinician-completed items. Each of the 10 questions is scored with a range of 0-6 points. An item score of 0 indicates item not present or normal, while an item score of 6 indicates severe or continuous presence of the symptoms. The total possible score is 60, and higher scores represent a more severe condition.

  8. Change from Baseline throughout the 12-week double-blind period at each timepoint assessed in - Work Productivity and Activity Impairment Specific Health Problem Questionnaire (WPAI-SHP)

    Time frame: Baseline to Week 12

    The WPAI-SHP is a 6-item questionnaire, with a recall period of the past 7 days. The WPAI measures impairments in both paid work and unpaid work. It measures absenteeism, presenteeism as well as impairment in unpaid activity because of the health problem under study.

  9. Change from Baseline throughout the 12-week double-blind period at each timepoint assessed in - EuroQol-5 Dimensions - 5 Levels (EQ-5D-5L)

    Time frame: Baseline to Week 12

    The EuroQol 5 Dimension 5 Level (EQ-5D-5L) is a self-reported outcome measure used to evaluate health outcomes over a wide range of health conditions and treatments. The EQ-5D consists of the EQ-5D descriptive system and the EQ visual analogue scale (VAS).

  10. Change from Baseline in the Changes in Sexual Functioning Questionnaire (CSFQ-14) total score at each timepoint assessed during the double-blind period

    Time frame: Baseline to Week 12

    The CSFQ-14 is a structured self-reported questionnaire designed to measure illness- and medication-related changes in sexual functioning that consists of 14 items measuring sexual functioning as a total score (14 items). There is a male and female version of the CSFQ-14 scale and a total score of less than 47 for men and less than 41 for women indicates sexual dysfunction. Lower scores are associated with worsened sexual functioning.

  11. Percent of men and women with normal and abnormal sexual functioning at each timepoint assessed during the double-blind period

    Time frame: Baseline to Week 12

    The CSFQ-14 is a structured self-reported questionnaire designed to measure illness- and medication-related changes in sexual functioning that consists of 14 items measuring sexual functioning as a total score (14 items). There is a male and female version of the CSFQ-14 scale and a total score of less than 47 for men and less than 41 for women indicates sexual dysfunction. Lower scores are associated with worsened sexual functioning.

  12. Percent of participants requiring one, two, three, four, or five doses of DT120 during the 52-week study (Part A and Part B) as assessed by participants meeting protocol-specified retreatment criteria during the 40-week open-label period

    Time frame: Day 1 to Week 52

    Percent of participants requiring one, two, three, four, or five doses of DT120 during the 52-week study (Part A and Part B) as assessed by participants meeting protocol-specified retreatment criteria during the 40-week open-label period

  13. Time to first treatment or lack of efficacy in the open-label period (Part B)

    Time frame: Day 1 to Week 52

    Measured as time from first dosing in the Double-blind period to participant meeting HAM-A criteria for re-dose or meeting criteria for lack of efficacy

  14. Need for DT120 treatment as assessed by the average number of DT120 treatments during the study

    Time frame: Day 1 to Week 52

    Average number of treatments assessed from first dose in the double-blind period through completion of the open label extension.

  15. HAM-A response (reduction from Baseline score of ≥50%) at each timepoint assessed during the 40-week open-label period

    Time frame: 40 week open label period

    The HAM-A consists of the following 14 items that encompass both psychological and somatic symptoms of anxiety. Each item is scored on a scale of 0 (not present) to 4 (severe), with a total score range of 0-56, where <17 indicates mild severity, 18-24 mild to moderate severity and 25-30 moderate to severe.

  16. HAM-A remission (total score ≤7) at each timepoint assessed during the 40-week open-label period

    Time frame: 40 week open label period

    The HAM-A consists of the following 14 items that encompass both psychological and somatic symptoms of anxiety. Each item is scored on a scale of 0 (not present) to 4 (severe), with a total score range of 0-56, where <17 indicates mild severity, 18-24 mild to moderate severity and 25-30 moderate to severe.

  17. Change from Double-blind Baseline throughout the 40-week open-label period at each timepoint assessed in Clinical Global Impression - Severity (CGI-S) Scale score

    Time frame: Baseline to Week 52

    The CGI-S scale assesses the clinician's impression of the participant's current severity of illness relative to the clinician's experience with patients who have the same diagnosis. The CGI-S comprises one item with 7 possible ratings (1-7 points), where a higher score indicates more severe illness.

  18. Change from Double-blind Baseline throughout the 40-week open-label period at each timepoint assessed in Patient Global Impression - Severity (PGI-S) Scale score

    Time frame: Baseline to Week 52

    The PGI scale is the patient-reported outcome (PRO) counterpart to the CGI scale. The PGI-S comprises one participant-completed item with 5 possible ratings (1-5) where a higher score indicates more severe illness.

  19. Change from Double-blind Baseline throughout the 40-week open-label period at each timepoint assessed in MADRS total score

    Time frame: Baseline to Week 52

    The MADRS is used to assess depression severity and to detect changes due to antidepressant treatment. The MADRS includes 10 clinician-completed items. Each of the 10 questions is scored with a range of 0-6 points. An item score of 0 indicates item not present or normal, while an item score of 6 indicates severe or continuous presence of the symptoms. The total possible score is 60, and higher scores represent a more severe condition.

  20. Change from Double-blind Baseline throughout the 40-week open-label period at each timepoint assessed in WPAI-SHP

    Time frame: Baseline to Week 52

    The WPAI-SHP is a 6-item questionnaire, with a recall period of the past 7 days. The WPAI measures impairments in both paid work and unpaid work. It measures absenteeism, presenteeism as well as impairment in unpaid activity because of the health problem under study.

  21. Change from Double-blind Baseline throughout the 40-week open-label period at each timepoint assessed in EQ-5D-5L

    Time frame: Baseline to Week 52

    The EuroQol 5 Dimension 5 Level (EQ-5D-5L) is a self-reported outcome measure used to evaluate health outcomes over a wide range of health conditions and treatments. The EQ-5D consists of the EQ-5D descriptive system and the EQ visual analogue scale (VAS).

  22. CSFQ-14 total score at each timepoint assessed during the open-label period

    Time frame: 40 week open label period

    The CSFQ-14 is a structured self-reported questionnaire designed to measure illness- and medication-related changes in sexual functioning that consists of 14 items measuring sexual functioning as a total score (14 items). There is a male and female version of the CSFQ-14 scale and a total score of less than 47 for men and less than 41 for women indicates sexual dysfunction. Lower scores are associated with worsened sexual functioning.

  23. Percent men and women with normal and abnormal sexual functioning at each timepoint assessed during the open-label period

    Time frame: 40 week open label period

    The CSFQ-14 is a structured self-reported questionnaire designed to measure illness- and medication-related changes in sexual functioning that consists of 14 items measuring sexual functioning as a total score (14 items). There is a male and female version of the CSFQ-14 scale and a total score of less than 47 for men and less than 41 for women indicates sexual dysfunction. Lower scores are associated with worsened sexual functioning.

Sponsors and collaborators

Lead sponsor

Definium Therapeutics US, Inc.

Industry

Registry information

Official study title

A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled, 12-Week Study (Part A) With a 40 Week Open-label Extension (Part B) Evaluating the Efficacy and Safety of Oral MM120 Compared to Placebo in the Treatment of Adults With Generalized Anxiety Disorder - Panorama

Important dates

Study start
2025
Primary completion
2026
Study completion
2027
First posted
Feb 5, 2025
Registry last updated
Jun 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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