Disorders - Depressive Disorders
Mayes, T. L., Tao, R., Rintelmann, J. W., Carmody, T., Hughes, C. W., Kennard, B. D., Stewart, S. M., Emslie, G. J.
Objective: Recent acute efficacy trials of anti-depressants in youth have suggested that high placebo-response rates in children (<12 years of age) indicate that children may be more responsive to non-specific treatment interventions. Yet, these studies generally have not presented age-specific outcome data. The objective of this study was to compare the efficacy outcomes for children (<12 years of age) and adolescents ([greater-than or equal to]12 years of age) using the combined data from two previously published double-blind, placebo-controlled trials of fluoxetine. Methods: Children (<12 years of age) and adolescents ([greater-than or equal to]12 years of age) with major depressive disorder were randomized to fluoxetine or placebo for 8-9 weeks of treatment. Outcome was assessed using the Children's Depression Rating Scale-Revised (CDRS-R) and Clinical Global Impressions scale. Results: Random regression of the CDRS-R showed a treatment group by age group interaction (F1,338=4.10, P=.044), indicating that the treatment effect was significantly more pronounced in children than adolescents. Within children, response at exit to fluoxetine was significantly better than placebo (56.9% vs 33.3%; P=.009). Adolescent response rates at exit were not significantly different between the groups (51.1% vs 38.6%; P=.128). Remission rates were low for both groups. Conclusion: In the combined fluoxetine trials, drug-placebo difference was greater in children compared with adolescents. Contrary to expectations, the placebo-response rate was lower in the children than the adolescents.
CNS Spectrums., 12(2) : 147-154
- Year: 2007
- Problem: Depressive Disorders
- Type: Randomised controlled trials
-
Stage: Disorder established (diagnosed disorder)
-
Treatment and intervention: Biological Interventions (any)
, Selective serotonin reuptake inhibitors (SSRIs)
March, John S., Silva, Susan, Petrycki, Stephen, Curry, John, Wells, Karen, Fairbank, John, Burns, Barbara, Domino, Marisa, McNulty, Steven, Vitiello, Benedetto, Severe, Joanne
CONTEXT: The Treatment for Adolescents With Depression Study evaluates the effectiveness of fluoxetine hydrochloride therapy, cognitive behavior therapy (CBT), and their combination in adolescents with major depressive disorder. OBJECTIVE: To report effectiveness outcomes across 36 weeks of randomized treatment. DESIGN AND SETTING: Randomized, controlled trial conducted in 13 academic and community sites in the United States. Cognitive behavior and combination therapies were not masked, whereas administration of placebo and fluoxetine was double-blind through 12 weeks, after which treatments were unblinded. Patients assigned to placebo were treated openly after week 12, and the placebo group is not included in these analyses by design. PARTICIPANTS: Three hundred twenty-seven patients aged 12 to 17 years with a primary DSM-IV diagnosis of major depressive disorder. INTERVENTIONS: All treatments were administered per protocol. MAIN OUTCOME MEASURES: The primary dependent measures rated blind to treatment status by an independent evaluator were the Children's Depression Rating Scale-Revised total score and the response rate, defined as a Clinical Global Impressions-Improvement score of much or very much improved. RESULTS: Intention-to-treat analyses on the Children's Depression Rating Scale-Revised identified a significant time x treatment interaction (P < .001). Rates of response were 73% for combination therapy, 62% for fluoxetine therapy, and 48% for CBT at week 12; 85% for combination therapy, 69% for fluoxetine therapy, and 65% for CBT at week 18; and 86% for combination therapy, 81% for fluoxetine therapy, and 81% for CBT at week 36. Suicidal ideation decreased with treatment, but less so with fluoxetine therapy than with combination therapy or CBT. Suicidal events were more common in patients receiving fluoxetine therapy (14.7%) than combination therapy (8.4%) or CBT (6.3%). CONCLUSIONS: In adolescents with moderate to severe depression, treatment with fluoxetine alone or in combination with CBT accelerates the response. Adding CBT to medication enhances the safety of medication. Taking benefits and harms into account, combined treatment appears superior to either monotherapy as a treatment for major depression in adolescents.
Archives of General Psychiatry, 64(10) : 1132-43
- Year: 2007
- Problem: Depressive Disorders, Suicide or self-harm behaviours (excluding non-suicidal self-harm)
, Suicide or self-harm with comorbid mental disorder
- Type: Randomised controlled trials
-
Stage: At risk (indicated or selected prevention)
, Disorder established (diagnosed disorder)
-
Treatment and intervention: Biological Interventions (any)
, Selective serotonin reuptake inhibitors (SSRIs), Psychological Interventions (any)
, Cognitive & behavioural therapies (CBT)
Emslie, G. J., Findling, R. L., Yeung, P. P., Kunz, N. R., Li, Y.
OBJECTIVE: The safety, efficacy, and tolerability of venlafaxine extended release (ER) in subjects ages 7 to 17 years with major depressive disorder were evaluated in two multicenter, randomized, double-blind, placebo-controlled trials conducted between October 1997 and August 2001. METHOD: Participants received venlafaxine ER (flexible dose, based on body weight; intent to treat, n = 169) or placebo (intent to treat, n = 165) for up to 8 weeks. The primary efficacy variable was the change from baseline in the Children's Depression Rating Scale-Revised score at week 8. RESULTS: There were no statistically significant differences between venlafaxine ER and placebo on the Children's Depression Rating Scale-Revised in either study. A post hoc age subgroup analysis of the pooled data showed greater improvement on the Children's Depression Rating Scale-Revised with venlafaxine ER than with placebo (-24.4 versus -19.9; p = .022) among adolescents (ages 12-17), but not among children (ages 7-11). The most common adverse events were anorexia and abdominal pain. Hostility and suicide-related events were more common in venlafaxine ER-treated participants than in placebo-treated participants. There were no completed suicides. CONCLUSIONS: Venlafaxine ER may be effective in depressed adolescents. However, its safety and efficacy in pediatric patients has not been established. Prescribers should monitor for signs of suicidal ideation and hostility in pediatric patients taking venlafaxine ER. Copyright 2007 copyright American Academy of Child and Adolescent Psychiatry.
Journal of the American Academy of Child & Adolescent Psychiatry, 46(4) : 479-488
- Year: 2007
- Problem: Depressive Disorders
- Type: Randomised controlled trials
-
Stage: Disorder established (diagnosed disorder)
-
Treatment and intervention: Biological Interventions (any)
, Serotonin-norepinephrine reuptake inhibitors (SNRIs)
Emslie, Graham J., Yeung, Paul P., Kunz, Nadia R.
INTRODUCTION: Because major depressive disorder (MDD) is often chronic and recurrent, even pediatric patients who are treated successfully during an acute episode may need longer-term treatment. Yet, data on long-term treatment with antidepressants in pediatric MDD are limited. OBJECTIVE: To evaluate long-term effectiveness and safety of treatment with venlafaxine extended-release (ER) in children and adolescents with MDD. METHODS: Subjects (n=86) 7-17 years of age with MDD entered a multicenter, open-label study of flexible-dose venlafaxine ER for 6 weeks of acute treatment, followed by continuation treatment for up to 6 months total treatment. The primary efficacy variable was the Children's Depression Rating Scale-Revised (CDRS-R) total score (intent-to-treat population). RESULTS: Mean CDRS-R total score decreased from 60.1+/-10.0 at baseline to 36.3+/-13.1 at week 6, and to 33.8+/-15.0 at 6 months (last observation carried forward). Among completers (n=36), the mean CDRS-R total score was 24.3+/-7.6 at the end of 6 months of treatment. The most frequent treatment-emergent adverse events were headache (53%), nausea (26%), infection (24%), abdominal pain (22%), vomiting (21%), and pharyngitis (19%). Fifteen (17%) participants discontinued due to adverse events, 9 of whom did so within the first 6 weeks. Serious adverse events (suicide attempt [two], hostility [two], hallucinations, depression, and pharyngitis) occurred in seven patients. There were no suicides. CONCLUSION: Most improvement with venlafaxine ER occurs during the first 6 weeks of treatment. Prescribers should be alert to signs of suicidal ideation and hostility in pediatric patients.
CNS Spectrums, 12(3) : 223-33
- Year: 2007
- Problem: Depressive Disorders
- Type: Randomised controlled trials
-
Stage: Disorder established (diagnosed disorder)
-
Treatment and intervention: Biological Interventions (any)
, Serotonin-norepinephrine reuptake inhibitors (SNRIs)
Goodyer, I., Dubicka, B., Wilkinson, P., Kelvin, R., Roberts, C., Byford, S., Breen, S., Ford, C., Barrett, B., Leech, A., Rothwell, J., White, L., Harrington, R.
Objective: To determine whether a combination of a selective serotonin reuptake inhibitor (SSRI) and cognitive behaviour therapy (CBT) together with clinical care is more effective in the short term than an SSRI and clinical care alone in adolescents with moderate to severe major depression. Design: Pragmatic randomised controlled superiority trial. Setting: 6 outpatient clinics in Manchester and Cambridge. Participants: 208 adolescents, aged 11-17, with moderate to severe major or probable major depression who had not responded to a brief initial intervention. Adolescents with suicidality, depressive psychosis, or conduct disorder were included. Interventions: 103 adolescents received an SSRI and routine care; 105 received an SSRI, routine care, and CBT. The trial lasted 12 weeks, followed by a 16 week maintenance phase. Main outcome measures: Change in score on the Health of the Nation outcome scales for children and adolescents (primary outcome) from baseline with 12 weeks as the primary and 28 weeks as the follow-up end point. Secondary measures were change in scores on the mood and feelings questionnaire, the revised children's depression rating scale, the children's global assessment scale, and the clinical global impression improvement scale. Results: At 12 weeks the treatment effect for the primary outcome was -0.64 (95% confidence interval -2.54 to 1.26, P=0.50). In a longitudinal analysis, there was no difference in effectiveness of treatment for the primary (average treatment effect 0.001, -1.52 to 1.52, P=0.99) or secondary outcome measures. On average there was a decrease in suicidal thoughts and self harm. There was no evidence of a protective effect of cognitive behaviour therapy on suicidal thinking or action. By 28 weeks, 57% were much or very much improved with 20% remaining unimproved. Conclusions: For adolescents with moderate to severe major depression there is no evidence that the combination of CBT plus an SSRI in the presence of routine clinical care contributes to an improved outcome by 28 weeks compared with the provision of routine clinical care plus an SSRI alone. Trial registration: Current Controlled Trials ISRCNT 83809224.
British Medical Journal., 335(7611) : 142-146
- Year: 2007
- Problem: Depressive Disorders
- Type: Randomised controlled trials
-
Stage: Disorder established (diagnosed disorder)
-
Treatment and intervention: Biological Interventions (any)
, Selective serotonin reuptake inhibitors (SSRIs), Psychological Interventions (any)
, Cognitive & behavioural therapies (CBT)
Gillham, Jane E., Reivich, Karen J., Freres, Derek R., Chaplin, Tara M., Shatte, Andrew J., Samuels, Barbra, Elkon, Andrea G., Litzinger, Samantha, Lascher, Marisa, Gallop, Robert, Seligman, Martin E.
The authors investigated the effectiveness and specificity of the Penn Resiliency Program (PRP; J. E. Gillham, L. H. Jaycox, K. J. Reivich, M. E. P. Seligman, & T. Silver, 1990), a cognitive-behavioral depression prevention program. Children (N = 697) from 3 middle schools were randomly assigned to PRP, Control (CON), or the Penn Enhancement Program (PEP; K. J. Reivich, 1996; A. J. Shatte, 1997), an alternate intervention that controls for nonspecific intervention ingredients. Children's depressive symptoms were assessed through 3 years of follow-up. There was no intervention effect on average levels of depressive symptoms in the full sample. Findings varied by school. In 2 schools, PRP significantly reduced depressive symptoms across the follow-up relative to both CON and PEP. In the 3rd school, PRP did not prevent depressive symptoms. The authors discuss the findings in relation to previous research on PRP and the dissemination of prevention programs. (PsycINFO Database Record (c) 2007 APA, all rights reserved) (journal abstract).
Journal of Consulting & Clinical Psychology, 75(1) : 9-19
- Year: 2007
- Problem: Depressive Disorders
- Type: Randomised controlled trials
-
Stage: Universal prevention
-
Treatment and intervention: Psychological Interventions (any)
, Other Psychological Interventions
Horowitz, J. L., Garber, J., Ciesla, J. A., Young, J. F., Mufson, L.
This study evaluated the efficacy of 2 programs for preventing depressive symptoms in adolescents. Participants were 380 high school students randomly assigned to a cognitive-behavioral program (CB), an interpersonal psychotherapy-adolescent skills training program (IPT-AST), or a no-intervention control. The interventions involved eight 90-min weekly sessions run in small groups during wellness classes. At postintervention, students in both the CB and IPT-AST groups reported significantly lower levels of depressive symptoms than did those in the no-intervention group, controlling for baseline depression scores; the 2 intervention groups did not differ significantly from each other. The effect sizes, using Cohen's d, for the CB intervention and the IPT-AST intervention were 0.37 and 0.26, respectively. Differences between control and intervention groups were largest for adolescents with high levels of depressive symptoms at baseline. For a high-risk subgroup, defined as having scored in the top 25th percentile on the baseline depression measure, the effect sizes for the CB and the IPT-AST interventions were 0.89 and 0.84, respectively. For the whole sample, sociotropy and achievement orientation moderated the effect of the interventions. Intervention effects were short term and were not maintained at 6-month follow-up.
Journal of Consulting & Clinical Psychology, 75(5) : 693-706
- Year: 2007
- Problem: Depressive Disorders
- Type: Randomised controlled trials
-
Stage: Universal prevention
-
Treatment and intervention: Psychological Interventions (any)
, Cognitive & behavioural therapies (CBT)
, Interpersonal therapy (IPT)
, Skills training
Cardemil, E. V., Reivich, K. J., Beevers, C. G., Seligman, M. E. P., James, J. Cardemil E. V., James, J.
We present 2-year follow-up data on the efficacy of the Penn Resiliency Program (PRP), a school-based depression prevention program, with low-income, racial/ethnic minority children. This program taught cognitive and social problem-solving skills to 168 Latino and African American middle school children who were at-risk for developing depressive symptoms by virtue of their low-income status. We had previously reported beneficial effects of the PRP up to 6 months after the conclusion of the program for the Latino children, but no clear effect for the African American children. In this paper, we extend the analyses to 24 months after the conclusion of the PRP. We continue to find some beneficial effects for the Latino children and no differentially beneficial effect for the African American children. Implications of findings and future research directions are discussed.
Behaviour Research & Therapy, 45(2) : 313-327
- Year: 2007
- Problem: Depressive Disorders
- Type: Randomised controlled trials
-
Stage: At risk (indicated or selected prevention)
-
Treatment and intervention: Psychological Interventions (any)
, Other Psychological Interventions
Burton, E., Stice, E., Bearman, S. K., Rohde, P.
Objective: Conduct a randomized trial to test whether a cognitive behavioral intervention designed to decrease de- pressive symptoms produces subsequent decreases in bulimic and substance use symptoms.
Method: Female participants (N 1⁄4 145) with elevated depressive symptoms were randomly assigned to a 4-session depres- sion intervention or a measurement-only condition and assessed through 6-month follow-up.
Results: Relative to control partici- pants, intervention participants showed decreases in depressive symptoms. Inter-
vention participants also showed signifi- cantly greater reductions in bulimic symptoms, but not substance use, and change in depressive symptoms medi- ated this effect for bulimic symptoms.
Conclusion: The results provide experi- mental support for the theory that affect disturbances contribute to bulimic path- ology, but do not support the affect regu- lation theory of substance use. VC 2006 by Wiley Periodicals, Inc.
Keywords: affect-regulation; depression; bulimia; substance use; randomized trial
International Journal of Eating Disorders, 40(1) : 27-36
- Year: 2007
- Problem: Depressive Disorders, Bulimia Nervosa
- Type: Randomised controlled trials
-
Stage: At risk (indicated or selected prevention)
-
Treatment and intervention: Psychological Interventions (any)
, Cognitive & behavioural therapies (CBT)
Balkin, RS., Tietjen-Smith, T., Caldwell, C., Shen, Y
Depression is a prevalent issue for women on college campuses. Undergraduate women participated in (a) an aerobic exercise class, (b) a weight-lifting class, or (c) a control group to determine the effect of exercise on depressive symptoms. Participants in the aerobic exercise group exhibited a significant decrease in depressive symptoms. Implications for college counselors are discussed.
Adultspan, 6 : 30-5
- Year: 2007
- Problem: Depressive Disorders
- Type: Controlled clinical trials
-
Stage: Universal prevention
-
Treatment and intervention: Complementary & Alternative Interventions (CAM)
, Physical activity, exercise
Bolton, Paul, Bass, Judith, Betancourt, Theresa, Speelman, Liesbeth, Onyango, Grace, Clougherty, Kathleen F., Neugebauer, Richard, Murray, Laura, Verdeli, Helen
CONTEXT: Prior qualitative work with internally displaced persons in war-affected northern Uganda showed significant mental health and psychosocial problems. OBJECTIVE: To assess effect of locally feasible interventions on depression, anxiety, and conduct problem symptoms among adolescent survivors of war and displacement in northern Uganda. DESIGN, SETTING, AND PARTICIPANTS: A randomized controlled trial from May 2005 through December 2005 of 314 adolescents (aged 14-17 years) in 2 camps for internally displaced persons in northern Uganda. INTERVENTIONS: Locally developed screening tools assessed the effectiveness of interventions in reducing symptoms of depression and anxiety, ameliorating conduct problems, and improving function among those who met study criteria and were randomly allocated (105, psychotherapy-based intervention [group interpersonal psychotherapy]; 105, activity-based intervention [creative play]; 104, wait-control group [individuals wait listed to receive treatment at study end]). Intervention groups met weekly for 16 weeks. Participants and controls were reassessed at end of study. MAIN OUTCOME MEASURES:
JAMA, 298(5) : 519-27
- Year: 2007
- Problem: Depressive Disorders
- Type: Controlled clinical trials
-
Stage: At risk (indicated or selected prevention)
, Disorder established (diagnosed disorder)
-
Treatment and intervention: Psychological Interventions (any)
, Interpersonal therapy (IPT)
Riggs, Pd, Mikulich-Gilbertson, S. K., Davies, R. D., Lohman, M., Klein, C., Stover S. K.
Objective: To evaluate the effect of fluoxetine hydrochloride vs placebo on major depressive disorder, substance use disorder (SUD), and conduct disorder (CD) in adolescents receiving cognitive behavioral therapy (CBT) for SUD. Design: Randomized controlled trial. Setting: A single-site study conducted between May 2001 and August 2004. Participants: One hundred twenty-six adolescents aged 13 to 19 years recruited from the community and meeting Diagnostic and Statistical Manual of Mental Disorders (Fourth Edition) diagnostic criteria for current major depressive disorder, lifetime CD, and at least 1 nontobacco SUD. Interventions: Sixteen weeks of fluoxetine hydrochloride, 20 mg/d, or placebo, with CBT. Main Outcome Measures: For depression, Childhood Depression Rating Scale-Revised and Clinical Global Impression Improvement; for SUD, self-reported nontobacco substance use and urine substance use screen results in the past 30 days; and for CD, self-reported symptoms in the past 30 days. Results: Fluoxetine combined with CBT had greater efficacy than did placebo and CBT according to changes on the Childhood Depression Rating Scale-Revised (effect size, 0.78) but not on the Clinical Global Impression Improvement treatment response (76% and 67%, respectively; relative risk, 1.08). There was an overall decrease in self-reported substance use (4.31 days; 95% confidence interval, 2.12-6.50) and CD symptoms (relative risk, 1.20; 95% confidence interval, 0.82-1.59), but neither difference between groups was statistically significant. The proportion of substance-free weekly urine screen results was higher in the placebo-CBT group than in the fluoxetine-CBT group (mean difference, 2.10; 95% confidence interval, 0.37-4.15). Conclusions: Fluoxetine and CBT had greater efficacy than did placebo and CBT on one but not both depression measures and was not associated with greater decline in self-reported substance use or CD symptoms. The CBT may have contributed to higher-than-expected treatment response and mixed efficacy findings, despite its focus on SUD.
Archives of Pediatrics & Adolescent Medicine, 161(11) : 1026-34
- Year: 2007
- Problem: Depressive Disorders
- Type: Randomised controlled trials
-
Stage: Disorder established (diagnosed disorder)
-
Treatment and intervention: Biological Interventions (any)
, Selective serotonin reuptake inhibitors (SSRIs), Psychological Interventions (any)
, Cognitive & behavioural therapies (CBT)