Is Prozac (fluoxetine) a good long-term treatment for children and teens grappling with depression to help prevent relapse?
According to a study published in this month’s American Journal of Psychiatry, the answer appears to be, “Yes.”
The researchers examined 168 children and adolescents ages 7 to 18. The study looked at whether or not a person relapsed, and how quickly, as the primary outcome measure.
In the group of kids taking Prozac, 42% relapsed within 6 months after being stabilized on the medication (9 months after starting treatment). In the group of kids taking a placebo, 69% relapsed in the same time period. Prozac is called a selective serotonin reuptake inhibitor or SSRI, and is a popularly prescribed antidepressant medication for adults and children.
Using a stricter definition of relapse, the researchers found similar results — 22% relapsed in the Prozac group, compared to 48% in the placebo group.
The researchers also found that the time to relapse was significantly shorter in the placebo group.
The upshot? If a teen or child is taking Prozac for depression and sees good results from it, they should probably maintain on it for as long as the doctor suggests, to minimize the risk of relapse. It’s not clear from this study if these results would generalize to other types of similar SSRI antidepressant medications.
Reference:
Emslie, G.J. et. al. (2008). Fluoxetine Versus Placebo in Preventing Relapse of Major Depression in Children and Adolescents. Am J Psychiatry 2008; 165:459-467
(5 votes, average: 3.4 out of 5)
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12 Responses to “Prozac, Kids and Long-Term Treatment” (Pingbacks/trackbacks not shown below)
just because the kids may not relapse as frequently when they take prozac it does not follow that prozac is a good long-term treatment for children.
I sure as hell wouldn’t put my kids on mind-altering substances when diet, therapy and exercise is just as likely to help and much more likely to sustain a positive outcome.
Family therapy is probably very important too as family dynamics often play a part in an unhappy childs life. It does not take overt abuse to effect a child emotionally—good old typical family dysfunction is enough to cause serious emotional problems sometimes. No ones to blame but the whole family needs to work together.
I think it’s really irresponsible to suggest that Prozac is good for kids without looking at other options first.
I have my doubts about the true significance of this study. You have to pay to read the whole article, which I didn’t do. Without that, you are stuck with the summary percentages. As an abstract or summary article, it makes it sound good. I would want to know more details before I jump on that bandwaggon.
Just as an example. Lets say you define relapse as a score above 20 on the HAM-D. Below 20, it’s not a relapse. And further lets say that 69% of the placebo group gets a score over 20 in 6 months. That means 69% relapse right? What if the average score for those who relapse is 21. Now, it may be that 69% of the prozac group had an average score of 19 during that 6 months, but only 49% scored over 20. Doesn’t look so good does it? Only 2 points difference.
Now, I’m not saying that this was how this study defined things, because I didn’t read it. I’m just saying that this is how it often tends to be done with these articles. In other words, show the stats that make the drug look the best.
John M. Grohol, Psy.D. at 11:40 am on
April 10th, 2008
That’s a good point. Arbitrary cut-off scores on the HAM-D (or any other depression measure) would not be a good way to define relapse, and it looks like in this study, they did not use such a cut-off. There was actually an accompanying editorial in this issue, the relevant part of which I’ll quote below that sheds some more light on the researchers’ findings:
In this issue, Emslie and colleagues report on a study of 102 youths 7–18 years of age with a primary diagnosis of major depressive disorder who had achieved good clinical response or remission in acute treatment with fluoxetine and then were randomly assigned to receive either fluoxetine or placebo in continuation treatment. Relapse was defined as persistent worsening in Children’s Depression Rating Scale—Revised (CDRS-R) score or a clinician determination of significant clinical deterioration. Of the patients in the fluoxetine group, 42% had a relapse during the 6-month blind continuation period, compared with 69% in the placebo group.
Relapse in terms of a second, stricter definition was examined by excluding clinician judgment and using only persistent worsening of the CDRS-R score. By that criterion, 22% of youths on fluoxetine relapsed, compared with 48% of those on placebo. Since participants were withdrawn from the study when they met the broader definition of relapse, these numbers do not include all those who would have met this stricter criterion had they stayed in the continuation study cell a bit longer. The design of the study thus reflected usual clinical decision making and did not keep patients in the study for whom that approach was no longer clinically reasonable. This strategy means that the 42% rate of failure on medication and the 69% rate of failure on placebo are the numbers that best reflect the experience our patients will have.
The 42% relapse rate in the fluoxetine group was disappointingly high. Just over half of patients who responded or remitted in acute treatment with fluoxetine had at least one residual depressive symptom when they entered the continuation treatment phase. Across both treatment groups the relapse rate was higher for those with one or more residual symptoms than for those with none, and the greatest difference in relapse rates was seen between the placebo and fluoxetine groups in those with no residual symptoms (67% versus 25%). Thus, fluoxetine continuation treatment was valuable across all participants but was particularly impressive in those who achieved complete symptom remission with acute treatment.
From: Continuation Treatment With Antidepressants in Child and Adolescent Major Depression
Thanks John. I didn’t see the editorial. There are still potential problems I see with how it was conducted and presented. I’m probably going to just go ahead and buy the article so I can read the whole thing.
But here one problem I see. The define relapse as “a persistent worsening of the CDRS-R” scores OR clinical determination of significant worsening. To me, it all comes down to how they define peristent worsening. Does that mean that scores are higher on a few subsequent administrations? Again, this does say anything about how much of the worsening was clinically significant. Then they present stats only based on the CDRS-R scores which show 22% of the prozac group worsening and 48% of the placebo group worsening. Again this is of unknown clinical significance because “worsening” is not clearly defined.
Now, if you take the stats the other way and look only at the clinical impressions of worsening, you get a different picture. If I am correct in understanding that the first measure of relapse simply pooled the clinician rated worsening with the CDRS-R, then we have no idea of what the results are when looking at clinical ratings of worsening only.
They other problem is that there was an initial phase when all patients took prozac, and then half were taken off and put on placebo. This, by itself, could have been the factor in producing the difference in the groups. The study has a potential confound with the effects of being on the medication and stopping it versus the drug’s ability to prevent relapse.
I went ahead and purchased the article. They did indeed use a set cutoff score to define relapse >= 40 on the CDRS-R, which had to be displayed over 2 consecutive meetings with the psychiatrist (separated by 2 weeks).
Additionally, if the score was under 40, they were considered to be relapsed if a clinician determined that “significant clinical deterioration suggested that full relapse would be likely without altering treatment, even if the CDRS-R score was
John M. Grohol, Psy.D. at 5:55 pm on
April 11th, 2008
DrJ, I think you have two good points there, and I appreciate you looking into the study further to give myself and our readers more information about this study.
The two issues you note do call into question the study’s findings, and one has to wonder if the researchers designed the study specifically in this manner to “stack the deck” for the Prozac findings.
Namely, that they used either a cut-off score, or a clinical judgment to define “relapse.” And it’s not clear why they would choose one over another.
The second point — that by taking people off of an active psychiatric medication can lead to greater rates of relapse — is an important one. Because it means we should be on the lookout for this kind of design in future studies as well, and how/whether the researchers try and control for this effect in any manner (have a third control arm might help).
Thanks again for the commentary and insights!
mom of child on prozac at 8:31 pm on
May 26th, 2008
my child is on prozac he has ADHD and he was put on it for his anger outburst he is also going through puberty is it helping? sometimes i think it is. I am not a drug pusher I look after mys son and stay on top of him & things, I don’t let him use his ADHD as an excuse for his behavior and he is held accountable for his actions. Unless you are in my shoes, u should not judge! Prozac is not a “mind altering” drug! It is not fair to the child to not find the best thing for him to allow him/her to be the best they can be, if they have problems! DIET AND EXERCISE for depression? give me a break!
Another mom at 2:46 pm on
May 28th, 2008
My child is on Prozac and my anxiety level increases every time I read an article about kids and Prozac. However, our experience with it has been an unmitigated success. My 9 yr old child was able to say I love you for the first time this year, and to make jokes and to laugh, and to make friends……
And to the earlier writer- of course we tried diet, excercise, therapy, hypnosis etc. etc. -that only works with regular kids who feel be “sad or worried”.
Concerned Step-Mom at 2:26 am on
July 1st, 2008
My 11-year-old (soon to be 12)step-son is on Prozac. His mother found a psychologist who agreed to put him on it when he was 5 (right after the divorce). I have been dating his father for almost 4 years, married for 1 year. The fact of his son being on Prozac has always concerned me. Even on the medication, his son displays disturbing behavior which seems to be escalating the older he gets. He is very violent, but only towards others, not himself. I always find myself wondering if the drugs are keeping him from being totally disturbed, or if they are harming him and his abilities. He has been on Prozac for more than half his life! I would have never put a child on mind altering medication unless it was a last resort, but this decision was not mine (or my husbands–who also disagrees with it). I have spoken with a child psychologist here who thinks we could (and should) wean him off of Prozac. When we approach the subject, my step-son says that his doctor has told him that he has to be on Prozac for the rest of his life. I am angry that such a young and promising child has been told that there is no other way. He is a smart kid, but has no self-estem because he has always been told that there is “something wrong with him.” I find it hard to believe that a 5-year-old, saddened by divorce, could have possibly been diagnosed as having such insurmountable problems that he would need to be heavily medicated for the rest of his life. I feel that he has been done (at the very least) a grave disservice.
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just because the kids may not relapse as frequently when they take prozac it does not follow that prozac is a good long-term treatment for children.
I sure as hell wouldn’t put my kids on mind-altering substances when diet, therapy and exercise is just as likely to help and much more likely to sustain a positive outcome.
Family therapy is probably very important too as family dynamics often play a part in an unhappy childs life. It does not take overt abuse to effect a child emotionally—good old typical family dysfunction is enough to cause serious emotional problems sometimes. No ones to blame but the whole family needs to work together.
I think it’s really irresponsible to suggest that Prozac is good for kids without looking at other options first.
I have my doubts about the true significance of this study. You have to pay to read the whole article, which I didn’t do. Without that, you are stuck with the summary percentages. As an abstract or summary article, it makes it sound good. I would want to know more details before I jump on that bandwaggon.
Just as an example. Lets say you define relapse as a score above 20 on the HAM-D. Below 20, it’s not a relapse. And further lets say that 69% of the placebo group gets a score over 20 in 6 months. That means 69% relapse right? What if the average score for those who relapse is 21. Now, it may be that 69% of the prozac group had an average score of 19 during that 6 months, but only 49% scored over 20. Doesn’t look so good does it? Only 2 points difference.
Now, I’m not saying that this was how this study defined things, because I didn’t read it. I’m just saying that this is how it often tends to be done with these articles. In other words, show the stats that make the drug look the best.
That’s a good point. Arbitrary cut-off scores on the HAM-D (or any other depression measure) would not be a good way to define relapse, and it looks like in this study, they did not use such a cut-off. There was actually an accompanying editorial in this issue, the relevant part of which I’ll quote below that sheds some more light on the researchers’ findings:
In this issue, Emslie and colleagues report on a study of 102 youths 7–18 years of age with a primary diagnosis of major depressive disorder who had achieved good clinical response or remission in acute treatment with fluoxetine and then were randomly assigned to receive either fluoxetine or placebo in continuation treatment. Relapse was defined as persistent worsening in Children’s Depression Rating Scale—Revised (CDRS-R) score or a clinician determination of significant clinical deterioration. Of the patients in the fluoxetine group, 42% had a relapse during the 6-month blind continuation period, compared with 69% in the placebo group.
Relapse in terms of a second, stricter definition was examined by excluding clinician judgment and using only persistent worsening of the CDRS-R score. By that criterion, 22% of youths on fluoxetine relapsed, compared with 48% of those on placebo. Since participants were withdrawn from the study when they met the broader definition of relapse, these numbers do not include all those who would have met this stricter criterion had they stayed in the continuation study cell a bit longer. The design of the study thus reflected usual clinical decision making and did not keep patients in the study for whom that approach was no longer clinically reasonable. This strategy means that the 42% rate of failure on medication and the 69% rate of failure on placebo are the numbers that best reflect the experience our patients will have.
The 42% relapse rate in the fluoxetine group was disappointingly high. Just over half of patients who responded or remitted in acute treatment with fluoxetine had at least one residual depressive symptom when they entered the continuation treatment phase. Across both treatment groups the relapse rate was higher for those with one or more residual symptoms than for those with none, and the greatest difference in relapse rates was seen between the placebo and fluoxetine groups in those with no residual symptoms (67% versus 25%). Thus, fluoxetine continuation treatment was valuable across all participants but was particularly impressive in those who achieved complete symptom remission with acute treatment.
From: Continuation Treatment With Antidepressants in Child and Adolescent Major Depression
Thanks John. I didn’t see the editorial. There are still potential problems I see with how it was conducted and presented. I’m probably going to just go ahead and buy the article so I can read the whole thing.
But here one problem I see. The define relapse as “a persistent worsening of the CDRS-R” scores OR clinical determination of significant worsening. To me, it all comes down to how they define peristent worsening. Does that mean that scores are higher on a few subsequent administrations? Again, this does say anything about how much of the worsening was clinically significant. Then they present stats only based on the CDRS-R scores which show 22% of the prozac group worsening and 48% of the placebo group worsening. Again this is of unknown clinical significance because “worsening” is not clearly defined.
Now, if you take the stats the other way and look only at the clinical impressions of worsening, you get a different picture. If I am correct in understanding that the first measure of relapse simply pooled the clinician rated worsening with the CDRS-R, then we have no idea of what the results are when looking at clinical ratings of worsening only.
They other problem is that there was an initial phase when all patients took prozac, and then half were taken off and put on placebo. This, by itself, could have been the factor in producing the difference in the groups. The study has a potential confound with the effects of being on the medication and stopping it versus the drug’s ability to prevent relapse.
I went ahead and purchased the article. They did indeed use a set cutoff score to define relapse >= 40 on the CDRS-R, which had to be displayed over 2 consecutive meetings with the psychiatrist (separated by 2 weeks).
Additionally, if the score was under 40, they were considered to be relapsed if a clinician determined that “significant clinical deterioration suggested that full relapse would be likely without altering treatment, even if the CDRS-R score was
DrJ, I think you have two good points there, and I appreciate you looking into the study further to give myself and our readers more information about this study.
The two issues you note do call into question the study’s findings, and one has to wonder if the researchers designed the study specifically in this manner to “stack the deck” for the Prozac findings.
Namely, that they used either a cut-off score, or a clinical judgment to define “relapse.” And it’s not clear why they would choose one over another.
The second point — that by taking people off of an active psychiatric medication can lead to greater rates of relapse — is an important one. Because it means we should be on the lookout for this kind of design in future studies as well, and how/whether the researchers try and control for this effect in any manner (have a third control arm might help).
Thanks again for the commentary and insights!
my child is on prozac he has ADHD and he was put on it for his anger outburst he is also going through puberty is it helping? sometimes i think it is. I am not a drug pusher I look after mys son and stay on top of him & things, I don’t let him use his ADHD as an excuse for his behavior and he is held accountable for his actions. Unless you are in my shoes, u should not judge! Prozac is not a “mind altering” drug! It is not fair to the child to not find the best thing for him to allow him/her to be the best they can be, if they have problems! DIET AND EXERCISE for depression? give me a break!
My child is on Prozac and my anxiety level increases every time I read an article about kids and Prozac. However, our experience with it has been an unmitigated success. My 9 yr old child was able to say I love you for the first time this year, and to make jokes and to laugh, and to make friends……
And to the earlier writer- of course we tried diet, excercise, therapy, hypnosis etc. etc. -that only works with regular kids who feel be “sad or worried”.
My 11-year-old (soon to be 12)step-son is on Prozac. His mother found a psychologist who agreed to put him on it when he was 5 (right after the divorce). I have been dating his father for almost 4 years, married for 1 year. The fact of his son being on Prozac has always concerned me. Even on the medication, his son displays disturbing behavior which seems to be escalating the older he gets. He is very violent, but only towards others, not himself. I always find myself wondering if the drugs are keeping him from being totally disturbed, or if they are harming him and his abilities. He has been on Prozac for more than half his life! I would have never put a child on mind altering medication unless it was a last resort, but this decision was not mine (or my husbands–who also disagrees with it). I have spoken with a child psychologist here who thinks we could (and should) wean him off of Prozac. When we approach the subject, my step-son says that his doctor has told him that he has to be on Prozac for the rest of his life. I am angry that such a young and promising child has been told that there is no other way. He is a smart kid, but has no self-estem because he has always been told that there is “something wrong with him.” I find it hard to believe that a 5-year-old, saddened by divorce, could have possibly been diagnosed as having such insurmountable problems that he would need to be heavily medicated for the rest of his life. I feel that he has been done (at the very least) a grave disservice.
