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Saturday, April 12, 2008

7 Reasons for placebo controlled trials in depression

antidepressants placebo
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


Aqua said...

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.

pi* said...

My concern is very depressed people in quality clinical trails being used to verify drugs that will be given to mildly depressed people.

Dr. Shock said...

I agree,it is more important to study the efficacy of psychotherapy in less severe depressed patients.

Dr. Shock said...

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

james said...

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?

Dr. Shock said...

@ james
Antidepressants have side effects they do not harm the human body regards Dr Shock

james said...

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?