Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
Register:
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ISRCTN |
Last refreshed on:
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17 October 2016 |
Main ID: |
ISRCTN97724780 |
Date of registration:
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20/08/2015 |
Prospective Registration:
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No |
Primary sponsor: |
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Public title:
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Disruptive mood and emotional conflict resolution in adolescent children of parents with recurrent depression or bipolar disorder and healthy controls
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Scientific title:
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Rates of psychopathology including Disruptive Mood Dysregulation Disorder and emotional conflict resolution among adolescent children of parents with recurrent Major Depressive Disorder versus those with Bipolar Disorder and matched healthy controls |
Date of first enrolment:
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27/07/2015 |
Target sample size:
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96 |
Recruitment status: |
Completed |
URL:
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http://isrctn.com/ISRCTN97724780 |
Study type:
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Observational |
Study design:
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Single-centre observational cross-sectional case-control study. (Screening)
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Phase:
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Countries of recruitment
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Turkey
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Contacts
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Name:
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Zehra
Topal |
Address:
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Ars. Gor. Dr. Zehra Topal, Abant Izzet Baysal Universitesi Tip Fakultesi
Izzet Baysal Ruh Sag. ve Hst. Egt. Ars. Hastanesi Cocuk Psikiyatri Poliklinigi
Agacli Mevkii
14300
Bolu
Turkey |
Telephone:
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Email:
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Affiliation:
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Name:
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Evren
Tufan |
Address:
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Abant Izzet Baysal Universitesi Tip Fak.
Izzet Baysal Ruh Sag. ve Hst. Egt. ve Ars. Hst. Cocuk Psikiyatri Poliklinigi
Agacli Mevkii
14300
Bolu
Turkey |
Telephone:
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Email:
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Affiliation:
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Key inclusion & exclusion criteria
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Inclusion criteria: For parents (in unipolar/bipolar groups): 1. Aged between 30- 65 years 2. Recurrent Major Depressive Disorder or Bipolar I/ II diagnosis (ascertained via SCID- I), 3. Followed at the outpatient department of Psychiatry of Abant Izzet Baysal University Medical Faculty, 4. Are in remission (CGI-S = 2, YMRS = 5, HAM-D-17 = 7)
For parents in control group: 1. Have brought their adolescent offspring for acute somatic symptoms to the pediatrics outpatient department of Abant Izzet Baysal University Medical Faculty within the study period 2. Are free of lifetime psychopathology (ascertained via SCID-I)
Exclusion criteria: For parents (in unipolar/bipolar groups): 1. Active disorder (CGI-S > 2, YMRS > 5, HAM-D-17 > 7) 2. Epilepsy/chronic neurological disorders/mental retardation 3. Active psychotic symptoms 4. Illiteracy
For parents in control group: 1. Life time history of psychopathology 2. Epilepsy/chronic neurological disorders/mental retardation 3. Illiteracy
For adolescent offspring: 1. Epilepsy/chronic neurological disorders/mental retardation 2. Illiteracy
Age minimum:
Age maximum:
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Disruptive Mood Dysregulation Disorder Mental and Behavioural Disorders
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Intervention(s)
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Parents' psychological status is evaluated with Structured Clinical Interview for DSM-IV Axis I Disorders (SCID-I). All parents will then complete SCL-90R, State-Trait Anxiety Inventory- Trait Version, General Functioning Subtest of the Family Assessment Scale, and Childhood Trauma Questionnaire- 28. The psychological status of adolescents are evaluated with the Kiddie-Sads-Present and Lifetime Version (K-SADS-PL). Additionally SMDD Module as well as DSM-5 criteria for DMDD will be screened. They also complete Children's Depression Inventory, State-Trait Anxiety Inventory- Trait Version, Childhood Trauma Questionnaire- 28. Neuropsychological evaluations are Stroop Color Word Test- TBAG Form and Emotional Stroop (word-face) paradigm. The visual component of the emotional stroop was formed from pictures in the NIMH Child Emotional Faces Picture Set (NIMH-ChEFS) and the verbal component from TUDADEN (Affective Norms of Turkish Words). Also, the pubertal status will be evaluated with self-report via Turkish translation of the Carskadon Puberty Scale.
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Primary Outcome(s)
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Reaction speed of adolescents in three groups (unipolar offspring, bipolar offspring, healthy controls) in emotional stroop trials (in milliseconds)
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Secondary Outcome(s)
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1. Reaction speeds of adolescents in three groups (unipolar offspring, bipolar offspring, healthy controls) in Stroop Color Word Test - TBAG Form (in milliseconds) 2. Rates of psychopathologies (including DMDD) according to structured interviews (K-SADS-PL)
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Source(s) of Monetary Support
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Investigator initiated and funded
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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