Efficacy of Adjunctive Aripiprazole to Either Valproate or Lithium in Bipolar Mania Patients Partially Nonresponsive to Valproate Lithium Monotherapy: A Placebo-Controlled Study
Objective: The authors evaluated the efficacy and safety of adjunctive aripiprazole in bipolar I patients with mania partially nonresponsive to lithium valproate monotherapy. Method: This multicenter, randomized, placebo-controlled study included outpatients experiencing a manic or mixed episode (wi...
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| Veröffentlicht in: | The American journal of psychiatry 2008-10, Vol.165 (10), p.1316-1325 |
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| creator | Vieta, Eduard T'joen, Caroline McQuade, Robert D. Carson, William H. Marcus, Ronald N. Sanchez, Raymond Owen, Randall Nameche, Laurence |
| description | Objective:
The authors evaluated the efficacy and safety of adjunctive aripiprazole in bipolar I patients with mania partially nonresponsive to lithium valproate monotherapy.
Method:
This multicenter, randomized, placebo-controlled study included outpatients experiencing a manic or mixed episode (with or without psychotic features). Patients with partial nonresponse to lithium valproate monotherapy (defined as a Young Mania Rating Scale total score ≥16 at the end of phases 1 and 2, with a decrease of ≤25% between phases) with target serum concentrations of lithium (0.6-1.0 mmol liter) or valproate (50-125 g ml) were randomly assigned in a 2:1 ratio to adjunctive aripiprazole (N=253; 15 or 30 mg day) or placebo (N=131) for 6 weeks.
Results:
Mean improvement from baseline in Young Mania Rating Scale total score at week 6 (primary endpoint) was significantly greater with aripiprazole (-13.3) than with placebo (-10.7). Significant improvements in Young Mania Rating Scale total score with aripiprazole versus placebo occurred from week 1 onward. In addition, the mean improvement in Clinical Global Impression Bipolar Version (CGI-BP) severity of illness (mania) score from baseline to week 6 was significantly greater with aripiprazole (-1.9) than with placebo (-1.6). Discontinuation rates due to adverse events were higher with aripiprazole than with placebo (9% versus 5%, respectively). Akathisia was the most frequently reported extrapyramidal symptom-related adverse event and occurred significantly more frequently among those receiving aripiprazole (18.6%) than among those receiving placebo (5.4%). There were no significant differences between treatments in weight change from baseline to week 6 (+0.55 kg and +0.23 kg for aripiprazole and placebo, respectively; last observation carried forward).
Conclusions:
Adjunctive aripiprazole therapy showed significant improvements in mania symptoms as early as week 1 and demonstrated a tolerability profile similar to that of monotherapy studies. |
| doi_str_mv | 10.1176/appi.ajp.2008.07101560 |
| format | Article |
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The authors evaluated the efficacy and safety of adjunctive aripiprazole in bipolar I patients with mania partially nonresponsive to lithium valproate monotherapy.
Method:
This multicenter, randomized, placebo-controlled study included outpatients experiencing a manic or mixed episode (with or without psychotic features). Patients with partial nonresponse to lithium valproate monotherapy (defined as a Young Mania Rating Scale total score ≥16 at the end of phases 1 and 2, with a decrease of ≤25% between phases) with target serum concentrations of lithium (0.6-1.0 mmol liter) or valproate (50-125 g ml) were randomly assigned in a 2:1 ratio to adjunctive aripiprazole (N=253; 15 or 30 mg day) or placebo (N=131) for 6 weeks.
Results:
Mean improvement from baseline in Young Mania Rating Scale total score at week 6 (primary endpoint) was significantly greater with aripiprazole (-13.3) than with placebo (-10.7). Significant improvements in Young Mania Rating Scale total score with aripiprazole versus placebo occurred from week 1 onward. In addition, the mean improvement in Clinical Global Impression Bipolar Version (CGI-BP) severity of illness (mania) score from baseline to week 6 was significantly greater with aripiprazole (-1.9) than with placebo (-1.6). Discontinuation rates due to adverse events were higher with aripiprazole than with placebo (9% versus 5%, respectively). Akathisia was the most frequently reported extrapyramidal symptom-related adverse event and occurred significantly more frequently among those receiving aripiprazole (18.6%) than among those receiving placebo (5.4%). There were no significant differences between treatments in weight change from baseline to week 6 (+0.55 kg and +0.23 kg for aripiprazole and placebo, respectively; last observation carried forward).
Conclusions:
Adjunctive aripiprazole therapy showed significant improvements in mania symptoms as early as week 1 and demonstrated a tolerability profile similar to that of monotherapy studies.</description><identifier>ISSN: 0002-953X</identifier><identifier>EISSN: 1535-7228</identifier><identifier>DOI: 10.1176/appi.ajp.2008.07101560</identifier><identifier>PMID: 18381903</identifier><identifier>CODEN: AJPSAO</identifier><language>eng</language><publisher>Washington, DC: American Psychiatric Association</publisher><subject>Adult ; Anticonvulsants - adverse effects ; Anticonvulsants - therapeutic use ; Antimanic Agents - adverse effects ; Antimanic Agents - therapeutic use ; Antipsychotic Agents - adverse effects ; Antipsychotic Agents - therapeutic use ; Aripiprazole ; Biological and medical sciences ; Bipolar disorder ; Clinical trials ; Dose-Response Relationship, Drug ; Double-Blind Method ; Drug therapy ; Drug Therapy, Combination ; Female ; Humans ; Illnesses ; Lithium Compounds - adverse effects ; Lithium Compounds - therapeutic use ; Male ; Manic depression ; Medical sciences ; Middle Aged ; Neuropharmacology ; Patients ; Pharmacology. Drug treatments ; Piperazines - adverse effects ; Piperazines - therapeutic use ; Psychiatric Status Rating Scales ; Psychoanaleptics: cns stimulant, antidepressant agent, nootropic agent, mood stabilizer ; Psychoanaleptics: cns stimulant, antidepressant agent, nootropic agent, mood stabilizer..., (alzheimer disease) ; Psychology. Psychoanalysis. Psychiatry ; Psychopharmacology ; Psychotropic drugs ; Quinolones - adverse effects ; Quinolones - therapeutic use ; Studies ; Valproic Acid - adverse effects ; Valproic Acid - therapeutic use</subject><ispartof>The American journal of psychiatry, 2008-10, Vol.165 (10), p.1316-1325</ispartof><rights>2008 INIST-CNRS</rights><rights>Copyright American Psychiatric Association Oct 2008</rights><lds50>peer_reviewed</lds50><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-a476t-ff33940faeb66bca9df56eb9d17cb5e9bac71626436922d0a690ed273594e2423</citedby><cites>FETCH-LOGICAL-a476t-ff33940faeb66bca9df56eb9d17cb5e9bac71626436922d0a690ed273594e2423</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktopdf>$$Uhttps://psychiatryonline.org/doi/epdf/10.1176/appi.ajp.2008.07101560$$EPDF$$P50$$Gappi$$H</linktopdf><linktohtml>$$Uhttps://psychiatryonline.org/doi/full/10.1176/appi.ajp.2008.07101560$$EHTML$$P50$$Gappi$$H</linktohtml><link.rule.ids>314,776,780,2842,21605,21606,21607,27901,27902,77536,77541</link.rule.ids><backlink>$$Uhttp://pascal-francis.inist.fr/vibad/index.php?action=getRecordDetail&idt=20747334$$DView record in Pascal Francis$$Hfree_for_read</backlink><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/18381903$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Vieta, Eduard</creatorcontrib><creatorcontrib>T'joen, Caroline</creatorcontrib><creatorcontrib>McQuade, Robert D.</creatorcontrib><creatorcontrib>Carson, William H.</creatorcontrib><creatorcontrib>Marcus, Ronald N.</creatorcontrib><creatorcontrib>Sanchez, Raymond</creatorcontrib><creatorcontrib>Owen, Randall</creatorcontrib><creatorcontrib>Nameche, Laurence</creatorcontrib><title>Efficacy of Adjunctive Aripiprazole to Either Valproate or Lithium in Bipolar Mania Patients Partially Nonresponsive to Valproate Lithium Monotherapy: A Placebo-Controlled Study</title><title>The American journal of psychiatry</title><addtitle>Am J Psychiatry</addtitle><description>Objective:
The authors evaluated the efficacy and safety of adjunctive aripiprazole in bipolar I patients with mania partially nonresponsive to lithium valproate monotherapy.
Method:
This multicenter, randomized, placebo-controlled study included outpatients experiencing a manic or mixed episode (with or without psychotic features). Patients with partial nonresponse to lithium valproate monotherapy (defined as a Young Mania Rating Scale total score ≥16 at the end of phases 1 and 2, with a decrease of ≤25% between phases) with target serum concentrations of lithium (0.6-1.0 mmol liter) or valproate (50-125 g ml) were randomly assigned in a 2:1 ratio to adjunctive aripiprazole (N=253; 15 or 30 mg day) or placebo (N=131) for 6 weeks.
Results:
Mean improvement from baseline in Young Mania Rating Scale total score at week 6 (primary endpoint) was significantly greater with aripiprazole (-13.3) than with placebo (-10.7). Significant improvements in Young Mania Rating Scale total score with aripiprazole versus placebo occurred from week 1 onward. In addition, the mean improvement in Clinical Global Impression Bipolar Version (CGI-BP) severity of illness (mania) score from baseline to week 6 was significantly greater with aripiprazole (-1.9) than with placebo (-1.6). Discontinuation rates due to adverse events were higher with aripiprazole than with placebo (9% versus 5%, respectively). Akathisia was the most frequently reported extrapyramidal symptom-related adverse event and occurred significantly more frequently among those receiving aripiprazole (18.6%) than among those receiving placebo (5.4%). There were no significant differences between treatments in weight change from baseline to week 6 (+0.55 kg and +0.23 kg for aripiprazole and placebo, respectively; last observation carried forward).
Conclusions:
Adjunctive aripiprazole therapy showed significant improvements in mania symptoms as early as week 1 and demonstrated a tolerability profile similar to that of monotherapy studies.</description><subject>Adult</subject><subject>Anticonvulsants - adverse effects</subject><subject>Anticonvulsants - therapeutic use</subject><subject>Antimanic Agents - adverse effects</subject><subject>Antimanic Agents - therapeutic use</subject><subject>Antipsychotic Agents - adverse effects</subject><subject>Antipsychotic Agents - therapeutic use</subject><subject>Aripiprazole</subject><subject>Biological and medical sciences</subject><subject>Bipolar disorder</subject><subject>Clinical trials</subject><subject>Dose-Response Relationship, Drug</subject><subject>Double-Blind Method</subject><subject>Drug therapy</subject><subject>Drug Therapy, Combination</subject><subject>Female</subject><subject>Humans</subject><subject>Illnesses</subject><subject>Lithium Compounds - adverse effects</subject><subject>Lithium Compounds - therapeutic use</subject><subject>Male</subject><subject>Manic depression</subject><subject>Medical sciences</subject><subject>Middle Aged</subject><subject>Neuropharmacology</subject><subject>Patients</subject><subject>Pharmacology. Drug treatments</subject><subject>Piperazines - adverse effects</subject><subject>Piperazines - therapeutic use</subject><subject>Psychiatric Status Rating Scales</subject><subject>Psychoanaleptics: cns stimulant, antidepressant agent, nootropic agent, mood stabilizer</subject><subject>Psychoanaleptics: cns stimulant, antidepressant agent, nootropic agent, mood stabilizer..., (alzheimer disease)</subject><subject>Psychology. Psychoanalysis. Psychiatry</subject><subject>Psychopharmacology</subject><subject>Psychotropic drugs</subject><subject>Quinolones - adverse effects</subject><subject>Quinolones - therapeutic use</subject><subject>Studies</subject><subject>Valproic Acid - adverse effects</subject><subject>Valproic Acid - therapeutic use</subject><issn>0002-953X</issn><issn>1535-7228</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2008</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><recordid>eNqFkcuO0zAUhiMEYsrAK4wsJJYpviR2w65U5SJ1YCQuYhedOLZw5drGdkYqb8Ub4tDOzJKVL_rO9x_pr6orgpeECP4aQjBL2IclxXi1xIJg0nL8qFqQlrW1oHT1uFpgjGndtezHRfUspX15Yibo0-qCrNiKdJgtqj9brY0EeUReo_W4n5zM5lahdTTBhAi_vVUoe7Q1-aeK6DvYED1khXxEu_JnpgMyDr01wVuI6BqcAXQD2SiXU7nEbMDaI_rkXVQpeJdmexE-mO401975OQTC8Q1aoxsLUg2-3niXo7dWjehLnsbj8-qJBpvUi_N5WX17t_26-VDvPr__uFnvamgEz7XWjHUN1qAGzgcJ3ahbroZuJEIOreoGkIJwyhvGO0pHDLzDaqSCtV2jaEPZZfXy5C1r_ppUyv3eT9GVyJ5SXDIwmSF-gmT0KUWl-xDNAeKxJ7ifi-rnovpSVD8X1d8VVQavzvZpOKjxYezcTAFenQFIEqyO4KRJ9xzFohGMNYVjJ-5f0P2K_4n_C7zkscU</recordid><startdate>20081001</startdate><enddate>20081001</enddate><creator>Vieta, Eduard</creator><creator>T'joen, Caroline</creator><creator>McQuade, Robert D.</creator><creator>Carson, William H.</creator><creator>Marcus, Ronald N.</creator><creator>Sanchez, Raymond</creator><creator>Owen, Randall</creator><creator>Nameche, Laurence</creator><general>American Psychiatric Association</general><scope>IQODW</scope><scope>CGR</scope><scope>CUY</scope><scope>CVF</scope><scope>ECM</scope><scope>EIF</scope><scope>NPM</scope><scope>AAYXX</scope><scope>CITATION</scope><scope>K9.</scope><scope>NAPCQ</scope></search><sort><creationdate>20081001</creationdate><title>Efficacy of Adjunctive Aripiprazole to Either Valproate or Lithium in Bipolar Mania Patients Partially Nonresponsive to Valproate Lithium Monotherapy: A Placebo-Controlled Study</title><author>Vieta, Eduard ; T'joen, Caroline ; McQuade, Robert D. ; Carson, William H. ; Marcus, Ronald N. ; Sanchez, Raymond ; Owen, Randall ; Nameche, Laurence</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-a476t-ff33940faeb66bca9df56eb9d17cb5e9bac71626436922d0a690ed273594e2423</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2008</creationdate><topic>Adult</topic><topic>Anticonvulsants - adverse effects</topic><topic>Anticonvulsants - therapeutic use</topic><topic>Antimanic Agents - adverse effects</topic><topic>Antimanic Agents - therapeutic use</topic><topic>Antipsychotic Agents - adverse effects</topic><topic>Antipsychotic Agents - therapeutic use</topic><topic>Aripiprazole</topic><topic>Biological and medical sciences</topic><topic>Bipolar disorder</topic><topic>Clinical trials</topic><topic>Dose-Response Relationship, Drug</topic><topic>Double-Blind Method</topic><topic>Drug therapy</topic><topic>Drug Therapy, Combination</topic><topic>Female</topic><topic>Humans</topic><topic>Illnesses</topic><topic>Lithium Compounds - adverse effects</topic><topic>Lithium Compounds - therapeutic use</topic><topic>Male</topic><topic>Manic depression</topic><topic>Medical sciences</topic><topic>Middle Aged</topic><topic>Neuropharmacology</topic><topic>Patients</topic><topic>Pharmacology. Drug treatments</topic><topic>Piperazines - adverse effects</topic><topic>Piperazines - therapeutic use</topic><topic>Psychiatric Status Rating Scales</topic><topic>Psychoanaleptics: cns stimulant, antidepressant agent, nootropic agent, mood stabilizer</topic><topic>Psychoanaleptics: cns stimulant, antidepressant agent, nootropic agent, mood stabilizer..., (alzheimer disease)</topic><topic>Psychology. Psychoanalysis. Psychiatry</topic><topic>Psychopharmacology</topic><topic>Psychotropic drugs</topic><topic>Quinolones - adverse effects</topic><topic>Quinolones - therapeutic use</topic><topic>Studies</topic><topic>Valproic Acid - adverse effects</topic><topic>Valproic Acid - therapeutic use</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Vieta, Eduard</creatorcontrib><creatorcontrib>T'joen, Caroline</creatorcontrib><creatorcontrib>McQuade, Robert D.</creatorcontrib><creatorcontrib>Carson, William H.</creatorcontrib><creatorcontrib>Marcus, Ronald N.</creatorcontrib><creatorcontrib>Sanchez, Raymond</creatorcontrib><creatorcontrib>Owen, Randall</creatorcontrib><creatorcontrib>Nameche, Laurence</creatorcontrib><collection>Pascal-Francis</collection><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>ProQuest Health & Medical Complete (Alumni)</collection><collection>Nursing & Allied Health Premium</collection><jtitle>The American journal of psychiatry</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Vieta, Eduard</au><au>T'joen, Caroline</au><au>McQuade, Robert D.</au><au>Carson, William H.</au><au>Marcus, Ronald N.</au><au>Sanchez, Raymond</au><au>Owen, Randall</au><au>Nameche, Laurence</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Efficacy of Adjunctive Aripiprazole to Either Valproate or Lithium in Bipolar Mania Patients Partially Nonresponsive to Valproate Lithium Monotherapy: A Placebo-Controlled Study</atitle><jtitle>The American journal of psychiatry</jtitle><addtitle>Am J Psychiatry</addtitle><date>2008-10-01</date><risdate>2008</risdate><volume>165</volume><issue>10</issue><spage>1316</spage><epage>1325</epage><pages>1316-1325</pages><issn>0002-953X</issn><eissn>1535-7228</eissn><coden>AJPSAO</coden><abstract>Objective:
The authors evaluated the efficacy and safety of adjunctive aripiprazole in bipolar I patients with mania partially nonresponsive to lithium valproate monotherapy.
Method:
This multicenter, randomized, placebo-controlled study included outpatients experiencing a manic or mixed episode (with or without psychotic features). Patients with partial nonresponse to lithium valproate monotherapy (defined as a Young Mania Rating Scale total score ≥16 at the end of phases 1 and 2, with a decrease of ≤25% between phases) with target serum concentrations of lithium (0.6-1.0 mmol liter) or valproate (50-125 g ml) were randomly assigned in a 2:1 ratio to adjunctive aripiprazole (N=253; 15 or 30 mg day) or placebo (N=131) for 6 weeks.
Results:
Mean improvement from baseline in Young Mania Rating Scale total score at week 6 (primary endpoint) was significantly greater with aripiprazole (-13.3) than with placebo (-10.7). Significant improvements in Young Mania Rating Scale total score with aripiprazole versus placebo occurred from week 1 onward. In addition, the mean improvement in Clinical Global Impression Bipolar Version (CGI-BP) severity of illness (mania) score from baseline to week 6 was significantly greater with aripiprazole (-1.9) than with placebo (-1.6). Discontinuation rates due to adverse events were higher with aripiprazole than with placebo (9% versus 5%, respectively). Akathisia was the most frequently reported extrapyramidal symptom-related adverse event and occurred significantly more frequently among those receiving aripiprazole (18.6%) than among those receiving placebo (5.4%). There were no significant differences between treatments in weight change from baseline to week 6 (+0.55 kg and +0.23 kg for aripiprazole and placebo, respectively; last observation carried forward).
Conclusions:
Adjunctive aripiprazole therapy showed significant improvements in mania symptoms as early as week 1 and demonstrated a tolerability profile similar to that of monotherapy studies.</abstract><cop>Washington, DC</cop><pub>American Psychiatric Association</pub><pmid>18381903</pmid><doi>10.1176/appi.ajp.2008.07101560</doi><tpages>10</tpages></addata></record> |
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| ispartof | The American journal of psychiatry, 2008-10, Vol.165 (10), p.1316-1325 |
| issn | 0002-953X 1535-7228 |
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| subjects | Adult Anticonvulsants - adverse effects Anticonvulsants - therapeutic use Antimanic Agents - adverse effects Antimanic Agents - therapeutic use Antipsychotic Agents - adverse effects Antipsychotic Agents - therapeutic use Aripiprazole Biological and medical sciences Bipolar disorder Clinical trials Dose-Response Relationship, Drug Double-Blind Method Drug therapy Drug Therapy, Combination Female Humans Illnesses Lithium Compounds - adverse effects Lithium Compounds - therapeutic use Male Manic depression Medical sciences Middle Aged Neuropharmacology Patients Pharmacology. Drug treatments Piperazines - adverse effects Piperazines - therapeutic use Psychiatric Status Rating Scales Psychoanaleptics: cns stimulant, antidepressant agent, nootropic agent, mood stabilizer Psychoanaleptics: cns stimulant, antidepressant agent, nootropic agent, mood stabilizer..., (alzheimer disease) Psychology. Psychoanalysis. Psychiatry Psychopharmacology Psychotropic drugs Quinolones - adverse effects Quinolones - therapeutic use Studies Valproic Acid - adverse effects Valproic Acid - therapeutic use |
| title | Efficacy of Adjunctive Aripiprazole to Either Valproate or Lithium in Bipolar Mania Patients Partially Nonresponsive to Valproate Lithium Monotherapy: A Placebo-Controlled Study |
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