Fortunately for the players, despite the appending doom touted by the media, the current research suggests Tβ4 is safe. 23 non-clinical toxicology studies have been performed “that demonstrate the safety of Tβ4 for its current and planned uses in man”. Significantly, a human clinical trial in healthy volunteers found “intravenous administration of Tβ4 appears to be safe and well-tolerated by all subjects with no dose limiting toxicity or serious adverse events reported”. Admittedly, this trial is limited in that it only followed subjects for a period of 28 days, and thus there is a need for further research if Tβ4 is ever to be developed as a medication.
A 2002 review concluded that although the data evaluated suggests that 5-HTP is more effective than placebo in the treatment of depression, the evidence was insufficient to be conclusive due to a lack of clinical data meeting the rigorous standards of today. More and larger studies using current methodologies are needed to determine if 5-HTP is truly effective in treating depression. In small controlled trials 5-HTP has also been reported to augment the antidepressant efficacy of the antidepressant clomipramine.