7 Reasons for placebo controlled trials in depression
Placebo-controlled trials in depression are scientifically necessary, ethical and feasible. As mentioned in a recent post about antidepressants for adolescents I am a great fan of placebo controlled trials, also in depression.
The best clinical trial is a placebo controlled trial, because:
- The response to placebo can vary considerably form around 10 to 50%.On average 30% of patients respond to placebo
- The proportion of patients who respond to placebo has increased with 7% per decade. This effect is mainly caused by the method of patient recruitment and the inclusion of patients with less severe forms of depression
- According to several studies,no difference in rates of suicide and attempted suicide was found in placebo controlled trials compared to the patients on antidepressants in those trials
- In a placebo controlled trial it is easier to distinguish between adverse reaction to the drug and disease symptoms
- Smaller sample sizes are required.They expose fewer patients to ineffective or potentially harmful drugs
- Studycosts are reduced
- New drugs become available sooner to patients if efficacious
Only placebo-controlled trials can give unambiguous evidence of efficacy and if future antidepressants were only tested against standard treatment, half of the studies would yield invalid (false positive or false negative)results.
The response of a patient to drug treatment is not only affected by the drug itself but also by:
- features of the illness.For instance in bulimia most patients also suffer from personality disorder which reponds to the structured visits and attention of the researcher. Not per se to the antidepressant
- The personality of the patient.
- The doctor-patient relationship. If you like your doctor you wouldn’t want to disappoint him of her.
- The setting of the treatment. Inpatients are different from outpatients. Depressed inpatients aremore often suicidal and or psychotically depressed
These confounding effects can only be reduced by a controlled trial, preferably a placebo controlled trial.
Adam, D., Kasper, .S., Möller, H., Singer, E.A. (2005). Placebo–controlled trials in major depression
are necessary and ethically justifiable. European Archives of Psychiatry and Clinical Neuroscience, 255(4), 258-260. DOI: 10.1007/s00406-004-0555-5
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April 12, 2008 @ 7:44 pm
I understand why the use of placebos in studies is important, but there is always a nagging voice in the back of my head about how ethical it is to treat someone with severe depression with a placebo.
It strikes me that from a utilitarian standpoint it is both effective and ethical… in the longterm more people get the opportunity for more benefits, safer medication usage, more clearly effective medications etc.
From an individual perspective, for instance the person with Major Depression who gets the placebo and remains severely depressed, I see a serious ethical dilemma.
…aqua
April 12, 2008 @ 11:48 pm
My concern is very depressed people in quality clinical trails being used to verify drugs that will be given to mildly depressed people.
April 13, 2008 @ 9:00 am
@pi*
I agree,it is more important to study the efficacy of psychotherapy in less severe depressed patients.
April 13, 2008 @ 9:04 am
@aqua
After the placebo period they should either switch to the investigated drug or other treatment options. Participating in trials or not they should be monitored closely.
Regards DrShock
April 18, 2008 @ 7:30 am
I agree with aqua.If a person is suffering from severe depression then he should take some serious action for curing it.
My son have been suffering from depression from 3 months.Doctors prescribed some anti-depressants.Do these pilss harm human body?
james
April 18, 2008 @ 9:52 am
@ james
Antidepressants have side effects they do not harm the human body regards Dr Shock
April 22, 2008 @ 6:24 am
Hey dr.Shock,
Thank you for your helpful advice.Can you please tell me what kind of side effect can they be?
I did many surveys on curing depression and found many resource.One of the resource really helped my son in curing his depression to much extent,
Kill depression
What do you think about this resource?
james
STAR*D Trial Sheds Little Light on how to manage Depression in Clinical Practice | Dr Shock MD PhD
January 3, 2009 @ 6:33 am
[…] There was no placebo arm in level one of the trial. Primary care physicians offer support, explanation and time (‘‘wait and see’’) as important interventions in the management of low mood. This makes generalisability difficult for patients in primary care. In this trial about a third of patients were recruited from primary care and they have been offered the option of a wait and see or a placebo option. Moreover, I am an advocate for placebo controlled trials. You can read in this post for the reasons why: 7 Reasons for placebo controlled trials in depression. […]
January 3, 2009 @ 8:03 pm
Hi Doc,
I came across this post and I was curious if you happen to know from your knowledge or you would care to venture a guess as to how long a placebo effect is supposed to last or if there are any studies as to the duration of a placebo effect?
I addressed this question going back to the VNS studies in which Drs. Lurie and Wolfe of Public Citizen expressed their opinions and essentially equated the results to a placebo effect. I had written to the doctors asking them to please advise me where in the medical literature one could learn of multi-year continuous placebo effects which my spouse and other study subjects apparently experienced from VNS therapy and no other.
Naturally, neither doctor cared to respond to me.
My best wishes to you and yours for a Happy, Healthy, Peaceful and Prosperous New Year
Warmly,
Herb
VNSdepression.com