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NCT01665950 · ClinicalTrials.gov registry record · Phase 2

Simvastatin Augmentation of Lithium Treatment in Bipolar Depression

A Phase 2 study, sponsored by Massachusetts General Hospital.

Terminated
Registry status
Phase 2
Development phase
4
Enrollment target

NCT01665950: Clinical Trial Phase 2 study, sponsored by Massachusetts General Hospital.

NCT01665950 is a Phase 2 study that was terminated before completion, run by Massachusetts General Hospital. The registered enrollment target is 4 participants. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01665950, a Phase 2 study, was terminated before completion, sponsored by Massachusetts General Hospital.

TERMINATED
Registry status
Phase 2
Development phase
4 participants
Enrollment target

Study Summary

Primary Aim: To estimate the antidepressant efficacy of simvastatin versus placebo as an adjunct to lithium, valproate, and/or other atypical antipsychotic therapy among individuals with bipolar I disorder in a nonpsychotic major depressive episode. Hypothesis: Simvastatin will be superior to placebo in improvement of depressive symptoms assessed by the Montgomery-Asberg Depression Rating Scale (MADRS).

Interventions

  • DRUG Placebo
  • DRUG Simvastatin

Trial Details

FieldValue
Enrollment Target 4 participants
Start Date 2012-08
Est. Completion 2014-10
Phase Phase 2

Sponsor

Massachusetts General Hospital

2,032 total trials

What the Registry Record Tells You About NCT01665950

The ClinicalTrials.gov registry entry for NCT01665950 describes a study currently listed as terminated, categorized as Phase 2. The registered enrollment target is 4 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Massachusetts General Hospital, which has 2,032 total studies on file at ClinicalTrials.gov.

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

NCT01665950 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT01665950 about?

NCT01665950 is a clinical study titled "Simvastatin Augmentation of Lithium Treatment in Bipolar Depression". Primary Aim: To estimate the antidepressant efficacy of simvastatin versus placebo as an adjunct to lithium, valproate, and/or other atypical antipsychotic therapy among individuals with bipolar I disorder in a nonpsychotic major depressive episode. Hypothesis: Simvastatin will be superior to place...

What is the current status of trial NCT01665950?

This trial is currently terminated. It is a Phase 2 study. The enrollment target is 4 participants. The study started on 2012-08. Estimated completion is 2014-10.

What interventions are being tested in trial NCT01665950?

The interventions under investigation include: Placebo (DRUG), Simvastatin (DRUG).

Who is sponsoring clinical trial NCT01665950?

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

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, the data changelog, or report a data error.