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NCT01514630 · ClinicalTrials.gov registry record · Phase 4

Creatine as a Treatment Option for Depression in Methamphetamine Using Females

A Phase 4 study, sponsored by Perry Renshaw.

Completed
Registry status
Phase 4
Development phase
14
Enrollment target

NCT01514630 is a Phase 4 study that has completed, run by Perry Renshaw. The registered enrollment target is 14 participants.

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The verdict

NCT01514630, a Phase 4 study, has completed, sponsored by Perry Renshaw.

COMPLETED
Registry status
Phase 4
Development phase
14 participants
Enrollment target

Study Summary

Methamphetamine (MA) is a psychostimulant drug with high abuse potential. MA can be smoked, snorted, injected or ingested orally to produce a release of high levels of dopamine into the brain and reduction of dopamine uptake. Its use results in feelings of pleasure, increased energy, and greater alertness lasting up to 12 hours. In 2010, the National Survey on Drug Use and Health reported that 353,000 Americans aged 12 or older reported being current MA users. Over the past decade MA use rates have fluctuated with current use rates on the decline; however, importantly, even though overall use rates are declining, use rates among males and females are approaching equal proportions. This use rate pattern is unlike other drugs of abuse, which typically demonstrate males using more than females. In some states, more females than males consider MA as their drug of choice. Namely, in a 2010 report in the state of Utah, more females were diagnosed with MA as a primary substance of abuse than males upon admission to treatment. Depression and MA use are highly comorbid. The relationship between MA use and depression is likely bidirectional, with MA use causing changes in mood and being used as a self-medicating behavior to reduce symptoms of depression. Several studies have shown that depression rates are higher in MA-using females compared to their male counterparts. It is likely that neurobiological and psychosocial mechanisms contribute to increased incidence of depressive symptoms in females. No clear treatment model exists to suggest how the comorbidity of depression and MA use is best managed. In studies of antidepressants for treatment of MA withdrawal and dependence, findings have suggested that antidepressants are ineffective for treating depressive symptoms. Creatine is an organic acid occurring naturally in vertebrates, where it takes part in energy homeostasis in tissues with fluctuating energy demands. Exogenous creatine has been shown to increase brain conce

Interventions

  • DRUG Creatine monohydrate

Trial Details

FieldValue
Enrollment Target 14 participants
Start Date 2013-01
Est. Completion 2015-02
Phase Phase 4

Sponsor

Perry Renshaw

7 total trials

What the Registry Record Tells You About NCT01514630

The ClinicalTrials.gov registry entry for NCT01514630 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 14 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Perry Renshaw, which has 7 total studies on file at ClinicalTrials.gov.

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

NCT01514630 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT01514630 about?

NCT01514630 is a clinical study titled "Creatine as a Treatment Option for Depression in Methamphetamine Using Females". Methamphetamine (MA) is a psychostimulant drug with high abuse potential. MA can be smoked, snorted, injected or ingested orally to produce a release of high levels of dopamine into the brain and reduction of dopamine uptake. Its use results in feelings of pleasure, increased energy, and greater ale...

What is the current status of trial NCT01514630?

This trial is currently completed. It is a Phase 4 study. The enrollment target is 14 participants. The study started on 2013-01. Estimated completion is 2015-02.

What interventions are being tested in trial NCT01514630?

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

Who is sponsoring clinical trial NCT01514630?

This trial is sponsored by Perry Renshaw, which has 7 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, or report a data error.