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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: Completed Phase 4 study, sponsored by Perry Renshaw.
NCT01514630 is a Phase 4 study that has completed, run by Perry Renshaw. The registered enrollment target is 14 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (97% lower). According to ClinicalTrials.gov, the official US trial registry.
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
Primary Outcome
Eight weeks of oral creatine supplementation will result in improvements in Hamilton Depression Rating Scale (HAMD) in female methamphetamine users. HAMD scoring is based on 17 items. Minimum score is 0 and maximum 52. A score of 0-7 is considered to be normal. Scores of 20 or higher indicate moderate or severe depression. 0-7 = Normal 8-13 = Mild Depression 14-18 = Moderate Depression 19-22 = Severe Depression ≥ 23 = Very Severe Depression
Interventions
- DRUG Creatine monohydrate
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 14 participants |
| Start Date | 2013-01 |
| Est. Completion | 2015-02 |
| Phase | Phase 4 |
What the finished NCT01514630 record still lists
NCT01514630 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 14 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (97% lower).
The record links to 0 conditions, and to 1 intervention - of which Creatine monohydrate is the first listed.
NCT01514630 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01514630's enrollment target sits among peer trials
14 1901st of 2000 higher than 91 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 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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