The following is a synopsis of clinical studies
currently being conducted in the field of mental health. All of these studies were placebo controlled, double-blind
studies, which are the most accurate.
All of these studies appear in the website, www.clinicaltrials.gov, and give a good cross-sampling of what studies are actually being conducted.
Following this table, are summaries and conclusions concerning this data:
Duration
of study Disorder Generic Medication Trade Name
|
12 weeks OCD
Fluoxetine
Prozac |
|
w/quetiapineorclomipramine |
|
Sponsor: University
of Sao Paulo, Brazil
Test Group: adults |
|
Novartis/ AstraZeneca |
|
|
|
8 months
ADHD
mehthylphenidate
Concerta
|
|
Sponsor: |
|
Massachusetts General Hospital, Cambridge, MA
Test Group: adults |
|
|
|
3 months
Bipolar Disorder taurine
(novel aminoacid)
|
|
Sponsor:
Test Group: |
|
Cambridge Health Alliance
adolescents and children |
|
|
|
3 weeks Schizophrenia Transcranial Magnetic Stimulation |
|
Sponsor:
Alfred Psychiatric Research Centre, Australia |
|
|
|
9 weeks ADHD/ODD atomoxetine
Strattera |
|
Sponsor:
Eli Lilly sponsor
Germany |
|
Test Group: |
|
children and adolescents |
|
|
|
6 weeks Bipolar
Disorder Paliperidone (ER) Invega, Semap (similar to risperidone) |
|
(combined with lithium or Valproate-depakene, Valproate, Valrelease) |
|
Sponsor: Johnson
& Johnson Pharmaceutical Research and Development adults
|
|
Test Group: Adults |
|
|
|
5 weeks A ADHD
methylphenidate
Ritalin |
|
Test Group:
prisoners in Sweden (with 47 week follow up. Only study that combines psychosocial therapy.) |
|
|
|
56 days bipolar disorder
quetiapine
Seroquel
|
|
Sponsor:
University of Cincinnati
Test Group: |
|
Adolescents and children |
|
|
|
2 weeks – |
|
60 days
Major depression
olanzapine
Zyprexa |
|
(therapy resistant depression) |
|
Sponsor: University
Hospital Freiburg, Germany
Test Group: Adults
|
|
|
|
|
|
?
Anorexia Nervosa
risperidone
Risperdal |
|
Sponsor:
The Children’s Hospital Denver U.S.
Test Group: |
|
Adolescents and children |
|
|
|
8 weeks
ADHD and bipolar disorder
aripiprazole Abilify |
|
Sponsor: Federal
University of Rio Grande De Sul, Brazil
Test Group: |
|
Children and Adolescents |
Conclusions concerning studies in field of mental health:
There are a number of conclusions that we can reach in looking at these studies and others. First, there are many studies,
most short term, that are being conducted in testing various pharmaceutical treatments on children and teens. There are no
long term studies being conducted on children and teens. Some reported studies are as short as two months. There are no studies
listed here longer than 1 year, and very few that are 1 year in length.
Second, in many of these studies, it seems as if they have come to conclusions before they have conducted the study.
For example, a study of methylphenidate, in this case Concerta, conducted at the Massachusetts General Hospital, collaborating
with Mcneil Consumer & Specialty Pharmaceuticals stated with regards to its published motives in conducting the study:
“We hypothesize ADHD symptomatology in adults with DSM-IV ADHD will be responsive to
Concerta treatment and Concerta-associated response of ADHD symptomatology in adults will be sustained over time.”
Another
example is a 56 day trial for the drug quetiapine in the treatment of bipolar
disorder by the University of Cincinnati, and cosponsored by the pharmaceutical company AstraZeneca,
“We hypothesize that quetiapine will be more efficacious than placebo for the treatment
of episodes of major depression associated with adolescent BP. Moreover, we hypothesize that quetiapine will be safe and well-tolerated
compared with placebo for the treatment of depression associated with adolescent BP.”
In the case of anorexia nervosa, The Children’s
Hospital in Denver states,
“Hypothesis 1: Subjects on risperidone will show a more significant
decrease in body image distortion and Eating Disorder Inventory -2 scores than subjects on placebo.”
Not all studies make these “conclusions” before they have begun the study, but it would seem that around
half do. If the actual “conclusion of these studies are reported in favor of the drug, it really is not a wonder. It
seems as if in all of these studies, it seems as if they have decided before they’ve started what the conclusion will
be. Is there a bias in the way the study was conducted, the way the data was compiled, or how the findings are interpreted
or presented.
If a study definitely reveals that a certain drug does not help at all,
it will not be published, but another study conducted or published, perhaps in a different manner that comes to the desired
conclusion. So how far can one put faith in the conclusions of studies supported or sponsored by pharmaceutical companies?
With so many very short range studies, and relatively few or none that are being designed to test the safety and also the
long-term efficacy of drugs, it would seem that with many of these studies, they seem to be designed to get the drug through
the gates so that they can be approved for various uses, rather than have a pure scientific motive. In the case of Prozac,
the most popular antidepressant, it is known, as an example, that it does lose its effectiveness in time. Is this the case
with medications for ADHD which might do well in a 12 week trial? So there are many questions raised as the long-term efficacy
of pharmaceuticals in the field of mental health, as well as the reliability of studies used to support their use.
Finally, in all areas of clinical trials, there are surprisingly few that test psychotherapy,
behavioral or lifestyle changes. Therefore, more clincial studies are needed
in these areas to give fuller support to this viable thought, that lifestyle changes, psychotherapy and behavioral changes
are effective and legitimate options in the treatment of even serious mental health disorders.
