Phase III Long-term Extension Trial to Assess Safety and Efficacy of CYB003 in MDD (EXTEND)
Public ClinicalTrials.gov record NCT06605105. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Phase III Long-Term Extension Trial With Optional Additional Doses of CYB003 to Assess the Safety and Long-term Efficacy in Participants With Major Depressive Disorder (EXTEND)
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
This is a long- term extension of the double-blind trials APPROACH (CYB003-002) and EMBRACE (CYB003-003). Its aim is to examine the safety and long-term efficacy of CYB003 in participants with MDD.
Study identification
- NCT ID
- NCT06605105
- Recruitment status
- Enrolling by invitation
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 468 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years to 85 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Jul 18, 2025 (Actual)
- Primary completion
- Jun 6, 2028 (Estimated)
- Completion
- Jun 6, 2028 (Estimated)
- Last update posted
- Sep 25, 2026
2025 – 2028
United States locations
- U.S. sites
- 42
- U.S. states
- 17
- U.S. cities
- 35
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Scottsdale Research Institute | Phoenix | Arizona | 85022 | — |
| Behavioral Research Specialists, LLC | Glendale | California | 91206 | — |
| Kadima Neuropsychiatry Institute | La Jolla | California | 92037 | — |
| TRIP Clinic and Psychedelic Science Institute | Los Angeles | California | 90004 | — |
| CalNeuro Research Group | Los Angeles | California | 90025 | — |
| Lipov Medical Group | Los Angeles | California | 90025 | — |
| Excell Research, Inc | Oceanside | California | 92056 | — |
| Open Mind Collective / UCSF Medical Center - Mount Zion | San Francisco | California | 94114 | — |
| Inland Psychiatric Medical Group Inc (IPMG Research) | San Juan Capistrano | California | 92675 | — |
| Mountain View Clinical Research | Denver | Colorado | 80209 | — |
| Starlight Clinical Research | Evergreen | Colorado | 80439 | — |
| Research Centers of America | Hollywood | Florida | 33024 | — |
| Clinical Neuroscience Solutions | Jacksonville | Florida | 32256 | — |
| K2 Medical Research | Lady Lake | Florida | 32159 | — |
| Segal Trials Center for Psychedelic Research | Lauderhill | Florida | 33319 | — |
| Accel Research Sites - Maitland | Maitland | Florida | 32751 | — |
| K2 Medical Research | Maitland | Florida | 32751 | — |
| Clinical Neuroscience Solutions, Inc | Orlando | Florida | 32801 | — |
| Charter Research | Orlando | Florida | 32803 | — |
| Combined Research Orlando Phase I-IV | Orlando | Florida | 32807 | — |
| Cenexel iResearcvh Atlanta, LLC | Atlanta | Georgia | 30030 | — |
| Atlanta Center For Medical Research | Atlanta | Georgia | 30331 | — |
| CenExel iResearch | Savannah | Georgia | 31405 | — |
| Uptown Research Institute | Chicago | Illinois | 60640 | — |
| Psychiatric Medicine Associates, LLC | Skokie | Illinois | 60076 | — |
| Psychiatric Medicine Associates | Skokie | Illinois | 60076 | — |
| Sunstone Medical, PC | Rockville | Maryland | 20850 | — |
| Adams Clinical Boston | Boston | Massachusetts | 02116 | — |
| Elixia Health | Springfield | Massachusetts | 01103 | — |
| Adams Clinical | Watertown | Massachusetts | 02472 | — |
| Institute for Integrative Therapies | Eden Prairie | Minnesota | 55347 | — |
| Redbird Research | Las Vegas | Nevada | 89119 | — |
| Global Medical Institutes, Princeton Medical Institute | Princeton | New Jersey | 08540 | — |
| Bio Behavioral Health | Toms River | New Jersey | 08755 | — |
| Adams Clinical Harlem | New York | New York | 10029 | — |
| Adams Clinical Bronx | The Bronx | New York | 10461 | — |
| Neurobehavioral Clinical Research | Canton | Ohio | 44720 | — |
| Adams Clinical Philadelphia | Philadelphia | Pennsylvania | 19104 | — |
| Clinical Neuroscience Solutions, CNS Healthcare | Memphis | Tennessee | 38119 | — |
| Adams Clinical Dallas | DeSoto | Texas | 75115 | — |
| Zillan Clinical Research | Houston | Texas | 77082 | — |
| Cedar Clinical Research | Draper | Utah | 84020 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 7 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT06605105, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Sep 25, 2026 · Synced Oct 20, 2026
Related: full search, browse by condition, browse by drug or therapy, browse by sponsor, browse by U.S. city.
Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT06605105 live on ClinicalTrials.gov.