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Cool Counseling, Therapy with Adolescents, Tough Kids Cool Counseling

A Brief History and Analysis of Antidepressant Medication Treatment for Youth with Depression Diagnoses

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The popular press intermittently acts surprised that antidepressant medications actually have little scientific evidence supporting their efficacy. It’s old news, but it’s still important news and I’m glad for the recent reports. See: http://www.everydayhealth.com/news/did-studies-lack-key-data-on-link-between-antidepressants-youth-suicides/

Rita and I published an article about this in 1996. Below, I’ve pasted a pre-print excerpt from an article I published with Duncan Campbell in 2009 in the Journal of Contemporary Psychotherapy. It includes a brief summary of antidepressant medication research through 2008 or so. Check it out:

A Brief History and Analysis of Antidepressant Medication Treatment for Youth

Medication treatment for depressed youth has evolved over three relatively distinct periods. First, prior to 1987, small exploratory studies examined tricyclic antidepressant (TCAs) efficacy with young patients diagnosed with major depressive disorder (MDD). Second, from 1987-1994 there were a number of randomized, controlled trials (RCTs) of TCA efficacy; these efforts often employed double-blind procedures and inactive placebo controls. Third, since 1997, research efforts have primarily focused on evaluating selective serotonin reuptake inhibitor (SSRI) efficacy with RCTs.

Early Research: Pre-1987

In the early 1980s, psychiatric and pharmaceutical researchers began testing TCAs with youth. Early conclusions about the safety and efficacy of TCAs were generally optimistic (Klein, Jacobs, & Reinecke, 2007). This is a tendency that has been identified in the literature and it may be due to methodological limitations, confirmation bias or an allegiance to the medical model, or financial incentives associated with the pharmaceutical industry (Klein et al., 2007; Luborsky et al., 1999). For example, on the basis of existing studies and their very small double-blind trial with nine prepubertal children, Kashani and colleagues (1984) concluded that amitrityline was possibly efficacious for treating depression in children. Interestingly, the authors’ tentative claim was made despite the fact that no statistically significant effect was observed for amitriptyline and even though 11% of their sample “developed a hypomanic reaction while on the protocol” (p. 350).

RCTs with TCAs

From 1965 to 1994 there were 13 published RCTs evaluating TCA efficacy. Most of these studies were conducted from 1987 to 1994 (Fisher & Fisher, 1996; Sommers-Flanagan & Sommers-Flanagan, 1996). These RCTs confirmed the premature hopefulness of Kashani and colleagues’ early claims. Indeed, no study ever published showed that TCAs outperformed placebo in the treatment of youth depression (Hazell, 2000). More importantly, it is currently recognized that TCAs possess dangerous side effect profiles, while offering no demonstrable advantage over placebo in the treatment of youth depression (Hazell, 2000; Pellegrino, 1996).

In the mid-1990s there was considerable speculation about why TCAs were ineffective for treating youth. The primary hypothesis for involved the fact that children appear to have immature adrenergic synaptic systems. This possibility precipitated a more systematic inquiry of serotonergic medications.

RCTs with SSRIs

Using PsychInfo and PubMed searches combined with cross-referencing, we identified 12 published RCTs evaluating SSRI efficacy with 11 of these studies from 1997 to 2007. In total, these studies compared 1,223 SSRI treated patients to a similar number of placebo controls. On the basis of the researchers’ own efficacy criteria, six RCTs observed outcomes favoring medication over placebo, and six observed nonsignificant differences. Researchers described efficacious outcomes for fluoxetine (3 of 4 studies; G. J. Emslie et al., 2002; G. J. Emslie et al., 1997; Simeon, Dinicola, Ferguson, & Copping, 1990; Treatment for Adolescents With Depression Study (TADS) Team, US, 2004), paroxetine (1 of 3; Berard, Fong, Carpenter, Thomason, & Wilkinson, 2006; G. Emslie et al., 2006; M. B. Keller, 2001), sertraline (1 of 1; K. D. Wagner et al., 2003), and citalopram (1 of 1; K. D. Wagner et al., 2004). Neither of two studies observed efficacy for venlafaxine (G. J. Emslie, Findling, Yeung, Kunz, & Li, 2007; Mandoki, Tapia, Tapia, & Sumner, 1997), and the single escitalopram study returned negative results (K. D. Wagner, Jonas, Findling, Ventura, & Saikali, 2006).

Methodological Issues

Assessing a medication’s efficacy is a complex process with challenges that are difficult to address. We believe, however, that the six aforementioned RCTs favoring SSRIs suffered from methodological problems and issues that temper their positive conclusions. For example, (a) two of the three fluoxetine studies were characterized by unusually high and disproportionate discontinuation rates in the placebo conditions; (b) 11 of the 12 studies based their conclusions exclusively on a structured psychiatric interview; (c) despite simultaneous examination of several outcomes, no study used statistical adjustments for multiple comparisons; (d) placebo washouts and statistical approaches that advantage medications were nearly always employed (R. P. Greenberg, 2001); (e) no procedures were used to evaluate double-blind integrity (R. P. Greenberg & Fisher, 1997); and (f) despite documented inter-racial differences in medication metabolism and responsiveness, conclusions were generalized to all youth and inappropriately failed to account for racial/cultural specificity (Lin, Poland, & Nakasaki, 1993).

Side Effects and Adverse Events

In RCTs and other studies, patients treated with SSRIs experienced substantially more disturbing side effects and adverse events than those not treated with SSRIs. For example, in one of the most rigorous studies to date, the Treatment of Adolescents with Depression Study (TADS), 11.9% of the fluoxetine group evidenced harm-related adverse events (compared to 4.5% in the Cognitive Behavioral Therapy [CBT] group) and 21% experienced psychiatric adverse events (1% in the CBT group). Further, as the authors noted, “…suicidal crises and nonsuicidal self-harming behaviors were not uncommon and, with the caveat that the numbers were so small as to make statistical comparisons suspect, seemed possibly to be associated with fluoxetine treatment” (March et al., 2006; The TADS Team, 2007 p. 818; Treatment for Adolescents With Depression Study (TADS) Team, US, 2004).

Findings like these necessitate critical inspection of study results and should attenuate positive conclusions about medication safety. For example, Emslie et al.’s (1997) study of youth depression was the first ever to demonstrate superior outcome for an SSRI. In addition to the study’s numerous methodological problems, the authors noted that 6.3% of the fluoxetine patients (n = 3) developed manic symptoms. Although this percentage may sound small, extrapolation suggests that 6,250 of every 100,000 fluoxetine-treated youth might develop manic symptoms. Ultimately, despite data based solely on psychiatrist ratings and a placebo condition discontinuation rate approaching 46%, the authors concluded that fluoxetine “…is safe and effective in children and adolescents with MDD” (p. 1037). Moreover, the authors’ intent-to-treat analysis possibly conferred an advantage for the active drug group. In our opinion, this methodological problem and the mania data make it premature to conclude that fluoxetine is safe and effective in children.

Similarly, despite striking data that appear to demonstrate otherwise, authors of the single positive paroxetine study concluded that paroxetine is “safe and effective” for young patients (M. B. Keller et al., 2001). However, in their results section, the research team reported serious adverse effects, “…in 11 patients in the paroxetine group, 5 in the imipramine group, and 2 in the placebo group” (p. 769). More specifically, five adverse effects in the paroxetine group involved suicidal ideation or gestures. Despite these data, the researchers presented their results as evidence for the efficacy and safety of paroxetine treatment for adolescent depression. Because 12% of the paroxetine-treated adolescents experienced at least one adverse event and because 6% of these patients manifested increased suicidality or suicidal gestures (compared with zero in the imipramine and placebo groups), we believe the authors’ conclusion departs from the data in a significant and concerning way.
Shortly after publication of the Keller et al. (2001) study, regulatory agencies in France, Canada, and Great Britain restricted SSRI use among youth. In September of 2004, an expert panel of the U.S. Food and Drug Administration (FDA) followed suit and voted 25-0 in support of an SSRI-suicide link. Later, the panel voted 15-8 in favor of a ‘black box warning’ on SSRI medication labels. The warning states:

“Antidepressants increased the risk compared to placebo of suicidal thinking and behavior (suicidality) in children, adolescents, and young adults in short-term studies of Major Depressive Disorder (MDD) and other psychiatric disorders. Patients of all ages who are started on antidepressant therapy should be monitored appropriately and observed closely for clinical worsening, suicidality, or unusual changes in behavior. Families and caregivers should be advised of the need for close observation and communication with the prescriber.”

In 2006, the FDA extended its SSRI suicidality warning to adult patients aged 18-24 years (United States Food and Drug Administration, 2007).

Combination Medication and Psychotherapy Treatments

Many view the 2004 TADs study as a ‘state of the science’ comparison of SSRI medication (fluoxetine; FLU) with CBT and their combination (FLU + CBT). To date, it represents the largest placebo-controlled study comparing mono-therapy (FLU or CBT alone) with combination therapy. Not surprisingly, the TADs study has generated numerous publications and much controversy (Antonuccio & Burns, 2004; Diller, 2005; Weisz, McCarty, & Valeri, 2006).

To summarize, initial 12-week outcomes showed that 71% of FLU + CBT patients evidenced “much” or “very much” improvement on the on the CGI-Improvement item, a clinician-based assessment. FLU alone produced a similar outcome (60.6%), whereas the CBT alone (43.2) outcome did not differ significantly from placebo (34.8%). Based on these outcomes, several CBT researchers and practitioners criticized the specific CBT delivered to TADs participants. Brent (2006), for example, described TADS psychotherapy as a relatively “dense treatment, with multiple CBT strategies, each delivered at a relatively low dose” (p. 1463). In comparing the initial TADs CBT outcomes with previous and subsequent CBT studies, Weisz et al. (2006) suggested that the TADs CBT was weaker than most CBT interventions, for various reasons:

“the CBT ES (effect size) generated in TADS is not characteristic of most CBT or psychotherapy effects on youth depression; 20 of the 23 other CBT programs. . . showed larger ES than the TADS version of CBT, and the mean ES value across the non-TADS CBT programs. . . was 0.48, markedly higher than the -0.07 ES associated with the TADS CBT intervention” (p. 147).

To complicate issues further, follow-up data suggest that the TADs CBT evidenced delayed effectiveness, as it eventually “caught up” with FLU and CBT+FLU (The TADS Team, 2007). At week 18, for example, there were no statistically significant differences between CBT and FLU, and by week 36 there were no statistical differences among the three groups (CBT, FLU, and CBT + FLU) on primary outcome measures. Although the interventions including FLU might evidence a speedier antidepressant effect, these results suggest that CBT is equally effective over time.

The depression treatment literature frequently includes recommendations for combined interventions in order to maximize outcomes (Watanabe, Hunot, Omori, Churchill, & Furukawa, 2007). Unfortunately, however, little data exists to support these recommendations. In addition to TADs, the only other published RCT comparison of mono- and combination treatments for depressed adolescents reported partial remission rates of 71% for CBT, 33% for sertraline, and 47% for combination (Melvin et al., 2006). Medication group patients also evidenced significantly more adverse events and side effects. Although the researchers attributed the delayed response in the combination group to sertraline, they concluded with the puzzling statement that “CBT and sertraline are equally recommended for the treatment for adolescents with depression, each demonstrating an equivalent response” (Melvin et al., 2006 p. 1160).

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Cool Counseling, Counseling and Psychotherapy Theory and Practice, Personal Reflections, Therapy with Adolescents, Tough Kids Cool Counseling

Non-Drug Options for Dealing with Depression

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Evidence supporting the efficacy of antidepressant medications continues to be weak. That doesn’t mean they never work; some individuals with depressive symptoms find them very helpful and that’s okay. But for many, antidepressant meds just don’t work very well . . . there are side effects and less than desirable antidepressant effects. This is why many people wonder: What are some of the best non-drug alternatives for treating symptoms of depression?

Here’s a short list that might be helpful.

1. Counseling or Psychotherapy: Going to a reputable and licensed mental-health professional who offers counseling or psychotherapy for depression can be very helpful. This may include individual, couple, or family therapy.

2. Vigorous aerobic exercise: Consider initiating and maintaining a regular cardiovascular or aerobic exercise schedule. This could involve a specific referral to a personal trainer and/or local fitness center (e.g., YMCA). In a recent small study of adolescents with clinical depression, 100% of the teens in the aerobic exercise group no longer met the diagnostic criteria for depression after receiving several months of exercise treatment.

3. Herbal remedies: Some individuals benefit from taking herbal supplements. In particular, there is evidence that omega-3 fatty acids (fish oil) and St. John’s Wort are effective in reducing depressive symptoms. It’s good to consult with a health-care provider if you’re pursuing this option.

4. Light therapy: Some people describe great benefits from light therapy. Specific information on light therapy boxes is available online and possibly through your physician.

5. Massage therapy: Research indicates some patients with depressive symptoms benefit from massage therapy. A referral to a licensed massage therapy professional is advised.

6. Bibliotherapy: Research indicates that some patients benefit from reading and working with self-help books or workbooks. The Feeling Good Handbook (Burns, 1999) and Mind over Mood (Greenberger and Padesky, 1995) are two self-help books used by many individuals.

7. Post-partum support: There is evidence suggesting that new mothers with depressive symptoms who are closely followed by a public-health nurse, midwife, or other professional experience fewer post-partum depressive symptoms. Additionally, new moms and all individuals suffering from depressive symptoms may benefit from any healthy and positive activities that increase social contact and social support.

8. Mild exercise and physical/social activities: Even if you’re not up to vigorous exercise, you should know that nearly any type of movement is an antidepressant. These activities could include, but not be limited to, yoga, walking, swimming, bowling, hiking, or whatever you can do! In the same exercise study mentioned above, 71% of the teenagers in the mild exercise group experienced a substantial reduction in their symptoms of depression.

9. Other meaningful activities: Never underestimate the healing power of meaningful activities. Activities could include (a) church or spiritual pursuits; (b) charity work; (c) animal caretaking (adopting a pet); and (d) many other activities that might be personally meaningful to you.

The preceding list is adapted from a tip-sheet in our book, “How to Listen so Parents will Talk and Talk so Parents will Listen.” See: http://www.amazon.com/How-Listen-Parents-Will-Talk/dp/1118012968/ref=la_B0030LK6NM_1_9?s=books&ie=UTF8&qid=1413432346&sr=1-9
Or: http://lp.wileypub.com/SommersFlanagan/

John and his sister working on their positive emotions.

Peg and John Singing at Pat's Wedding

 

Counseling and Psychotherapy Theory and Practice, Parenting, Personal Reflections

The Return of Mother’s Little Helper . . .

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This week Allen E. Ivey (the creator of the microcounseling approach) sent me a link to an article claiming that exercise is better for long-term brain functioning than medications. He was “venting” because he thinks this is not “new” information and instead constitutes basic common sense that everyone should embrace. The fact that exercise is good for neurological development and functioning is obvious and it can be frustrating to see the media acting surprised over and over again that life experiences—including counseling and psychotherapy—improves health, life satisfaction, and brain functioning.

Dr. Ivey’s comments and the article he sent reminded me of an unpublished piece I wrote a few years ago. It was a sarcastic commentary on a recent (at the time) publication touting the efficacy of antidepressants in treating depressive symptoms in mothers.

Here’s the piece. Sarcasm included.

The Return of Mother’s Little Helper

            Mother’s little helper is back.

            In a recent landmark study published in the Journal of the American Medical Association, a prestigious group of researchers reported that children with depression improved or recovered when their depressed mothers became less depressed. The researchers were surprised and optimistic that an environmental change—mothers becoming less depressed—could directly help children whom they thought had biological depression. This is an important finding, especially given concerns about prescribing psychotropic medicines directly to children.

            Having closely followed pharmaceutical research in child psychiatry, I’m always skeptical about landmark studies and promising new drugs, but try to stay balanced and hopeful. When I mentioned the research results to my graduate students in counseling and social work, all of whom happened to be women, they felt no need for balance or hope. They responded in unison.

            “No duh. Obviously children will do better if their mothers aren’t depressed. Who needs a study to tell you that?”

            I felt instantly defensive for pharmaceutical researchers everywhere. Okay, maybe the study demonstrated the obvious, but helping children be less depressed is clearly a good thing.

            My students weren’t convinced. They asked, “What treatment did the mothers’ get?”

            “Mostly they got Celexa.” Celexa is very similar to Prozac. They’re both classified as ‘SSRIs,’ meaning they selectively focus on making serotonin more plentiful in crucial brain regions.

            My cynical students pressed on: “Did the makers of Celexa fund the study?”

            “No,” I responded. “Forest Laboratories makes Celexa, but the study was funded by the National Institute of Mental Health.” I felt redeemed; the study was objective.

            “How many of the authors were paid by Forest Laboratories?”

            I happened to have the article with me, so I looked at the back page where financial disclosures are conveniently listed—in very small print. I squinted my way through: “Only 3 authors name Forest Laboratories as giving them money. And Forest Laboratories is thanked in the fine print for supplying all the medication for free.”

            Actually, that wasn’t too bad. There were 15 coauthors on the study; only 20% were linked to Forest Laboratories.

            But my picky students wanted to know about the numbers, so I explained that 151 mothers started the study, but 37 (24.5%) dropped out before three months. Overall, 38 of the 114 remaining mothers recovered from their depressive condition and another 16 improved somewhat. The authors report an overall response rate of 47%.

            A student pecked at her calculator and declared. “No way! Fifty-four of 151 isn’t 47%, it’s 36%; they’re either lying, cheating, or very bad at arithmetic.”

            “How about the kids,” another asked.  “How many of them got better?”

            “Well, it’s complex and hard to say, but overall the researchers report that, of 105 kids, 9 were significantly affected during the study, 4 in a positive direction and 5 in a negative direction.”

            The students mumbled and grumbled. “Are you kidding? That’s not much improvement.” They went on to rant a bit about never knowing a depressed, sleep-deprived mother—including themselves—who looked forward to 18 hours of screeching children and smelly diapers? One student, now a grandmother, noted that Valium (the original mother’s little helper) was the most prescribed drug in the U.S. from 1969-1982 and such a big pharmaceutical success that it inspired a Rolling Stones song. Unfortunately, Valium turned out to be terribly addictive, but now apparently, there’s Celexa, Prozac, and other options for overwhelmed mothers.

            After a few more stories, my students asked, “What were the study’s conclusions?”

            I read aloud: “. . . these findings suggest that it is important to provide vigorous treatment to mothers if they are depressed.”

            Throughout the room, eyes began to roll.

            “That’s a big surprise. They want depressed moms to feel guilty if they don’t take antidepressants. That’s what they mean by ‘vigorous treatment.’ As if a hard life is made better by serotonin? How much did they spend on that study anyway?”

            “I really don’t know,” I answered.  “Maybe half a million?”

            The student with the calculator pecked away again: “They should use that money to do a study on something that might really help depressed mothers.”

            “Like what?” I asked.

            “Like maybe a study on the effectiveness of splitting half a million among 114 moms—that’s over $4,300 each. They could just give them the money, or pay for some counseling and parenting consultations, or health club memberships, or childcare, or massages, or vocational training. Better yet, the researchers could use the money to train fathers to hang around the house and be helpful, rather than lying around watching sports and reading Penthouse.”

            At that point I decided class was over. I’d learned about as much as I could handle for one day.

Parenting, Therapy with Adolescents

A Few Facts about Children and Teenagers and Antidepressant Medications

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Information about Antidepressant Medications: What Parents and Concerned Adults Should Know

By John Sommers-Flanagan, Ph.D.

Why You Shouldn’t Have Your Sad, Cranky, or Depressed Child Take Antidepressant Meds?

Several million American children and teenagers take antidepressant meds. This use of antidepressants is unjustified. Here’s why:

1.   Commonly used antidepressants (like Prozac, Zoloft, Paxil, Celexa, Cymbalta, etc.) don’t have much scientific support. Much of the research shows that antidepressants are no more effective than a sugar pill for reducing depressive symptoms.

2.   Antidepressants have side effects that include hyperactivity, insomnia, stomach pain, agitation, and increased suicide potential.

3    Sexual side effects are of special concern. For example, most antidepressants delay orgasm and can be used to effectively treat premature ejaculation in males; they also may inhibit orgasm in females. No one knows how these side effects influence sexual development

4.   Several years ago the FDA released a Public Health Advisory warning about increased reports of suicidality in youth who had been treated with antidepressants.

5.   Even psychiatric journals acknowledge that non-drug approaches to treating child and adolescent depression should be used before trying medication treatment.

6.   Generally, adding antidepressant medications to non-drug treatments are no more effective than the non-drug treatments by themselves.

7.   As we all know, life is hard and we all have to face challenging situations—situations that can make us feel sad, angry, and guilty. The problem is that antidepressants don’t teach young people anything about handling difficult emotions and coping with life. As our behavior therapy friends like to say, remember, “a pill is not a skill.”

Why You Should Consider Putting Your Child on Antidepressant Medications?

Here are some reasons you might ask a doctor to prescribe antidepressants to your child.

1.   When other, less risky approaches to dealing with depression, such as exercise, a healthier diet, more time listening and caring about the huge stresses of the teen years, and family assistance coping with life’s joys and disappointments have not provided relief.

2.   When counseling or psychotherapy with a credentialed professional who has a positive reputation working with youth has been tried for at least 10 sessions with no improvement. Studies have shown that counseling or psychotherapy is effective in treating depressed youth and the effects may be maintained after the treatment has ended (in contrast to medications, which often must be continued indefinitely).

3.   Your child is actively suicidal and other options haven’t helped. As strange as it may sound, although newer antidepressants appear to increase suicide risk among non-suicidal youth, they can sometimes reduce suicide risk in youth who are already suicidal.

4.   You, or another parent, have a strong history of depression and that depression was dramatically relieved by an antidepressant drug; if so, it may be reasonable, if your child becomes severely depressed, to begin the same medication. Of course, the medication should be closely monitored and you should make sure you’re not confusing your personal struggles with depression with your child’s unique condition.

5.   For personal reasons, it may be your preference and your child’s preference to try medications. If so, you should proceed with caution and work with a physician with a positive reputation.

This information is provided, in part, to balance most of the promotional advertising generated by pharmaceutical companies. It’s very important for consumers to have access to balanced information. Of course, much more information is available on the internet, but I recommend that you do your best to find balanced informational sources. Pharmaceutical companies tend to overstate antidepressant effectiveness and other organizations may demonize antidepressants. The truth is that antidepressant medications help some young people, but they’re not generally very effective, and they produce disturbing side effects. Choosing whether to have your children or teens take antidepressants is a very difficult decision. This handout is designed to provide you a small amount of information that may be helpful to you as you face this challenging decision.