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NCT01601210 · ClinicalTrials.gov registry record · Early Phase 1

Dose-Ranging Trial of Creatine Augmentation for Adolescent Females With Treatment-Resistant Major Depressive Disorder

A Early Phase 1 study, sponsored by Perry Renshaw.

Completed
Registry status
Early Phase 1
Development phase
32
Enrollment target

NCT01601210: Completed Early Phase 1 study, sponsored by Perry Renshaw.

NCT01601210 is a Early Phase 1 study that has completed, run by Perry Renshaw. The registered enrollment target is 32 participants, below the 53-participant average among 2,764 other Early Phase 1 trials with a reported enrollment target (40% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01601210, a Early Phase 1 study, has completed, sponsored by Perry Renshaw.

COMPLETED
Registry status
Early Phase 1
Development phase
32 participants
Enrollment target

Study Summary

The purpose of this study is to see if creatine, which is a naturally occurring chemical in the body, is effective for treating Major Depressive Disorder (MDD) in female teenagers. The primary hypothesis is that compared to placebo, 2g, 4g, and 10g of creatine monohydrate for eight weeks will be associated with a significant increase in brain phosphocreatine (PCr) concentrations.

Primary Outcome

The primary hypothesis is that compared to placebo, 2g, 4g, and 10g of creatine monohydrate for eight weeks will be associated with a significant increase in brain phosphocreatine (PCr) concentrations.

Interventions

  • DRUG Creatine monohydrate or placebo

Trial Details

FieldValue
Enrollment Target 32 participants
Start Date 2012-06
Est. Completion 2014-05
Phase Early Phase 1
Perry Renshaw

7 total trials

What the finished NCT01601210 record still lists

NCT01601210 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 32 participants, a relatively small participant target, below the 53-participant average among 2,764 other Early Phase 1 trials with a reported enrollment target (40% lower).

The record links to 0 conditions, and to 1 intervention - of which Creatine monohydrate or placebo is the first listed.

NCT01601210 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT01601210 about?

NCT01601210 is a clinical study titled "Dose-Ranging Trial of Creatine Augmentation for Adolescent Females With Treatment-Resistant Major Depressive Disorder". The purpose of this study is to see if creatine, which is a naturally occurring chemical in the body, is effective for treating Major Depressive Disorder (MDD) in female teenagers. The primary hypothesis is that compared to placebo, 2g, 4g, and 10g of creatine monohydrate for eight weeks will be as...

What is the current status of trial NCT01601210?

This trial is currently completed. It is a Early Phase 1 study. The enrollment target is 32 participants. The study started on 2012-06. Estimated completion is 2014-05.

What interventions are being tested in trial NCT01601210?

The interventions under investigation include: Creatine monohydrate or placebo (DRUG).

Who is sponsoring clinical trial NCT01601210?

This trial is sponsored by Perry Renshaw, which has 7 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT01601210's enrollment target sits among peer trials

32 775th of 2000 higher than 1,207 of 2,000 other Early Phase 1 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Early 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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Source: ClinicalTrials.gov NCT01601210, the US trial registry maintained by the National Library of Medicine. NCT01601210 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.