This is the abstract for a clinical trial from this month’s American Journal of Psychiatry. It’s not posted here to either praise or debunk. It’s just the most recent Clinical Trial I could find to illustrate another point [although it is kind of an interesting study]:
A Randomized, Double-Blind Placebo-Controlled Trial of Oral Creatine Monohydrate Augmentation for Enhanced Response to a Selective Serotonin Reuptake Inhibitor in Women With Major Depressive Disorder
by In Kyoon Lyoo, Sujung Yoon, Tae-Suk Kim, Jaeuk Hwang, Jieun E. Kim, Wangyoun Won, Sujin Bae, and Perry F. Renshaw
American Journal of Psychiatry. 2012 169:937–945.
Objective: Antidepressants targeting monoaminergic neurotransmitter systems, despite their immediate effects at the synaptic level, usually require several weeks of administration to achieve clinical efficacy. The authors propose a strategy of adding creatine monohydrate [creatine]) to a selective serotonin reuptake inhibitor [SSRI] in the treatment of patients with major depressive disorder. Such augmentation may lead to a more rapid onset of antidepressant effects and a greater treatment response, potentially by restoring brain bioenergetics at the cellular level.
Method: Fifty-two women with major depressive disorder were enrolled in an 8-week double-blind placebo-controlled clinical trial and randomly assigned to receive escitalopram in addition to either creatine [5 g/day, N=25] or placebo [N=27]. Efficacy was primarily assessed by changes in the Hamilton Depression Rating Scale [HAM-D] score.
Results: In comparison to the placebo augmentation group, patients receiving creatine augmentation showed significantly greater improvements in HAM-D score, as early as week 2 of treatment. This differential improvement favoring creatine was maintained at weeks 4 and 8. There were no differences between treatment groups in the proportion of patients who discontinued treatment prematurely [creatine: N=8, 32.0%; placebo: N=5, 18.5%] or in the overall frequency of all reported adverse events [creatine: 36 events; placebo: 45 events].
Conclusions: The current study suggests that creatine augmentation of SSRI treatment may be a promising therapeutic approach that exhibits more rapid and efficacious responses in women with major depressive disorder.
Abstracts of medical journal articles are maintained on PubMed, some of which are available in full text although most require subscription for full access. Most journals allow free access to academic institutions and their faculties. In the case of Clinical Trials, there is another [wonderful] resource, ClinicalTrials.gov, a database of clinical trials. In this case, I searched for "creatine" and quickly located the Clinical Trial for the above study:
The History of Changes link is a valuable tool when vetting a trial – take a look. Then, scrolling down the page, it has the sites where the Clinical Trial was conducted:
And so to my first concern. Over the last year, I’ve run into a number of Clinical Trials that look like this:
I’m not even sure they’re trying to hide anything. Maybe there are so many people looking for trials that they get annoying calls, but they are hiding whether they mean to or not. I want to know if the trial comes from Duke Medical Center or some Clinical Research Center next to a Union Mission in Raleigh. ClinicalTrials.gov is about transparency.
But my main point is about that Tab that says No Study Results Posted. We wouldn’t expect it to say anything else under the current system with this particular study. Results are only required for certain kinds of studies, and they’re only required to be posted within a year of the end. Here’s what the header for the Results page looks like when the results are in:
It’s the study with the locations above [An Open-Label Comparison of Duloxetine to Other Alternatives for the Management of Diabetic Peripheral Neuropathic Pain]. If you scroll down that page, it has the study results. There’s a lot there – a whole lot! It’s pretty impressive and I can see why they give them a year to post their results. It looks like a lot of work to put together.
I’m looking at all of this with the wide-eyed hope that with enforcement of FDAAA and the addition of the TEST Act [the TEST Act…], we’ll finally have a route to data transparency, and I’m checking out the machinery by which it might come our way. Obviously, there’s more checking to do but that’s enough for a starter…
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