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NCT01701258 · ClinicalTrials.gov registry record · Phase 1
An Investigation of Early Life Stress and Depression
A Phase 1 study, sponsored by Mclean Hospital.
- Completed
- Registry status
- Phase 1
- Development phase
- 153
- Enrollment target
NCT01701258: Completed Phase 1 study, sponsored by Mclean Hospital.
NCT01701258 is a Phase 1 study that has completed, run by Mclean Hospital. The registered enrollment target is 153 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (155% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01701258, a Phase 1 study, has completed, sponsored by Mclean Hospital.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 153 participants
- Enrollment target
Study Summary
The purpose of this study is to investigate brain pathways within adult females (with a history of CSA that occurred between the ages of 5-14) with and without a current diagnosis of major depressive disorder (MDD). Hypotheses: The CSA/MDD participants will be characterized by (1) reduced reward responsiveness and prefrontal cortex activity, but increased cortisol levels, (2) reduced dopamine activity, and (3) reduced dopamine transporter binding. The over-arching purpose of the study is to (1) identify individuals at risk for psychopathology and maladaptive behavior, (2) prevent re-victimization, and (3) develop more targeted therapeutic interventions.
Primary Outcome
Utilizing 11C-altropane during positron emission tomography (PET) scanning allows us to measure dopamine active transporter (DAT) binding potential. Our outcome measure is Nondisplacable Binding Potential (BPND). BPND refers to the ratio at equilibrium of specifically bound radioligand to that of nondisplaceable radioligand in tissue. \*Higher BPND scores indicate greater binding potential
Interventions
- DRUG Placebo
- DRUG Amisulpride
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 153 participants |
| Start Date | 2013-08 |
| Est. Completion | 2017-05 |
| Phase | Phase 1 |
What the finished NCT01701258 record still lists
NCT01701258 is an interventional study that assigns participants to a tested intervention. The registered 153 participants enrollment target is mid-sized for trials with a published cap, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (155% higher).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT01701258 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01701258 about?
NCT01701258 is a clinical study titled "An Investigation of Early Life Stress and Depression". The purpose of this study is to investigate brain pathways within adult females (with a history of CSA that occurred between the ages of 5-14) with and without a current diagnosis of major depressive disorder (MDD). Hypotheses: The CSA/MDD participants will be characterized by (1) reduced reward r...
What is the current status of trial NCT01701258?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 153 participants. The study started on 2013-08. Estimated completion is 2017-05.
What interventions are being tested in trial NCT01701258?
The interventions under investigation include: Placebo (DRUG), Amisulpride (DRUG).
Who is sponsoring clinical trial NCT01701258?
This trial is sponsored by Mclean Hospital, which has 140 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01701258's enrollment target sits among peer trials
153 358th of 2000 higher than 1,642 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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