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NCT01913535 · ClinicalTrials.gov registry record · Phase 2

Proof-of-Concept Trial of CERC-501 Augmentation of Antidepressant Therapy in Treatment-Resistant Depression

A Phase 2 study, sponsored by Massachusetts General Hospital.

Terminated
Registry status
Phase 2
Development phase
8
Enrollment target

NCT01913535: Clinical Trial Phase 2 study, sponsored by Massachusetts General Hospital.

NCT01913535 is a Phase 2 study that was terminated before completion, run by Massachusetts General Hospital. The registered enrollment target is 8 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (94% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01913535, a Phase 2 study, was terminated before completion, sponsored by Massachusetts General Hospital.

TERMINATED
Registry status
Phase 2
Development phase
8 participants
Enrollment target

Study Summary

This study is looking at the efficacy, rapidity, safety, and tolerability of two doses of oral CERC-501 for treating patients with treatment resistant depression who are taking an antidepressant that is not working for them.

Primary Outcome

This instrument is completed with a structured interview guide by the clinician based on his/her assessment of the patient's symptoms. This structured interview has been validated for use with time frames shorter than one week. Scale items are assessed based on symptoms within the past 24 hours. A higher score indicates more depression symptoms. Total scores range from 0 (normal) to 22 (severe). To better estimate the baseline, we did not use simply the cross-sectional assessment at baseline, b

Interventions

  • DRUG Placebo
  • DRUG CERC-501

Trial Details

FieldValue
Enrollment Target 8 participants
Start Date 2013-09-12
Est. Completion 2016-01-22
Phase Phase 2
Massachusetts General Hospital

2,032 total trials

Why NCT01913535 stopped before completion

NCT01913535 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 8 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (94% lower).

The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.

NCT01913535 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT01913535 about?

NCT01913535 is a clinical study titled "Proof-of-Concept Trial of CERC-501 Augmentation of Antidepressant Therapy in Treatment-Resistant Depression". This study is looking at the efficacy, rapidity, safety, and tolerability of two doses of oral CERC-501 for treating patients with treatment resistant depression who are taking an antidepressant that is not working for them.

What is the current status of trial NCT01913535?

This trial is currently terminated. It is a Phase 2 study. The enrollment target is 8 participants. The study started on 2013-09-12. Estimated completion is 2016-01-22.

What interventions are being tested in trial NCT01913535?

The interventions under investigation include: Placebo (DRUG), CERC-501 (DRUG).

Who is sponsoring clinical trial NCT01913535?

This trial is sponsored by Massachusetts General Hospital, which has 2,032 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT01913535's enrollment target sits among peer trials

8 1990th of 2000 higher than 5 of 2,000 other Phase 2 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 2 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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Source: ClinicalTrials.gov NCT01913535, the US trial registry maintained by the National Library of Medicine. NCT01913535 (small enrollment · none site footprint · terminated) retrieved and formatted by PlainTrial, see methodology.