Ignite Creation Date:
2024-05-06 @ 1:39 AM
Last Modification Date:
2024-10-26 @ 11:07 AM
Study NCT ID:
NCT01863628
Status:
UNKNOWN
Last Update Posted:
2015-03-17
First Post:
2013-05-21
Brief Title:
Recognition and Early Intervention on Prodrome in Bipolar Disorders
Sponsor:
Guangzhou Psychiatric Hospital
Organization:
Guangzhou Psychiatric Hospital
Study Overview
Official Title:
Recognition and Early Intervention on Prodrome in Bipolar Disorders a Longitudinal Prospective Study of the Offspring of Parents With Bipolar Disorder
Status:
UNKNOWN
Status Verified Date:
2015-03
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Background and study hypothesis
Many studies including prospective studies have been demonstrated that a long symptomatic prodromal phase exists prior to the onset of full-brown bipolar disorder lasting for 9-12 years Egeland et al 2000 During the prodromal stage there are three main clusters of syndromes including hypomaniamania symptoms depressive symptoms and signs of attention deficit hyperactivity disorders Correll et al 2007 Tillman et al 2003 Mantere et al 2008 Of the hypomaniamania symptoms decreased sleep elevated mood irritability mood lability increased energy and psychomotor agitation are present most frequently The prodromal depressive symptoms are reported to be depressed mood anhedonia insomnia feelings of worthlessness Among patients with bipolar disorders 225 reported to comorbid with pediatric ADHD In addition some symptoms are considered as non-specific such as decreased functioning anger outburst social isolation and anxiety Egeland et al 2000
Offspring of parents with bipolar disorders are much likely to present prodromal symptoms compared to offspring of healthy parents In a 10-year longitudinal study using 55 prodromal symptoms checklist Egeland et al2002 found that 38 offspring of parents with bipolar disorder were considered as at risk compared to 17 in children of healthy parents In a 15-year follow-up study Duffy et al2009 found that 327 offspring aged 8-25 years old of parents with bipolar disorder met the criteria of major mood episode
Objectives
One primary objective of this study is to prospectively identify the prodromal stage of bipolar disorder
Another primary objective is to conduct a randomized place-controlled trial of aerobic exercise on people who suffering from prodromal symptoms to the extent of significantly impaired function with attempt at delaying or preventing the onset of a full-blown bipolar disorder
Design of study and the procedures
The study will consist of two phases one-week screening period and a randomized placebo-controlled 3-month trial During the screening period offspring of parents with bipolar disorder will undergo systematically clinical evaluations The offspring will be evaluated with clinical symptoms assessing scales neuropsychological tests magnetic resonance imaging During the 3-month trial period the offspring who meet the inclusion criteria will be randomly assigned to receive treatment of aerobic exercise placebo or wait-list group Psychiatrists are scheduled to assess mood treatment outcome during the 3-month trial
Subjects and treatment It is expected that 120 offspring of parents with bipolar disorder aged between 10-25 years meeting the inclusion of prodromal stage will be included in the study All of the offspring will undertake the Kiddie Sads Present and Lifetime Version K-SADS-PL and a 70 checklist items of potential prodromal symptoms suggest by us as well as by Dr Correll et al 2007 The parents of these offspring are to have a DSM-IV Diagnostic and Statistical Manual of Mental Disorders-defined bipolar disorder bipolar I or II confirmed by the Chinese version of Structured Clinical interview for DSM-IV-TR Axis I Disorders patient edition SCID-IP First et al 2002 The offspring are to be recruited through the referrals by their parents who will receive psychiatric services in the Guangzhou psychiatric Hospital
The offspring will be randomly assigned to aerobic exercise and placebo controlled groups The aerobic exercise would include cycling joggingtable tennis and playing badminton for 40 mins at least 3 times a week for 3 months In each exercise participants are supposed to exercise to the extent of getting sweaty In the placebo group participants will receive general psychoeducation including delivering knowledge on symptoms discussion of the suffering mental difficulties and general coping techniques
Significance
Bipolar disorder is a common chronic and recurrent mental disorder The recognition of prodromal stage of bipolar disorder and the early intervention on it may help delay or prevent the onset of bipolar disorder
Many studies including prospective studies have been demonstrated that a long symptomatic prodromal phase exists prior to the onset of full-brown bipolar disorder lasting for 9-12 years Egeland et al 2000 During the prodromal stage there are three main clusters of syndromes including hypomaniamania symptoms depressive symptoms and signs of attention deficit hyperactivity disorders Correll et al 2007 Tillman et al 2003 Mantere et al 2008 Of the hypomaniamania symptoms decreased sleep elevated mood irritability mood lability increased energy and psychomotor agitation are present most frequently The prodromal depressive symptoms are reported to be depressed mood anhedonia insomnia feelings of worthlessness Among patients with bipolar disorders 225 reported to comorbid with pediatric ADHD In addition some symptoms are considered as non-specific such as decreased functioning anger outburst social isolation and anxiety Egeland et al 2000
Offspring of parents with bipolar disorders are much likely to present prodromal symptoms compared to offspring of healthy parents In a 10-year longitudinal study using 55 prodromal symptoms checklist Egeland et al2002 found that 38 offspring of parents with bipolar disorder were considered as at risk compared to 17 in children of healthy parents In a 15-year follow-up study Duffy et al2009 found that 327 offspring aged 8-25 years old of parents with bipolar disorder met the criteria of major mood episode
Objectives
One primary objective of this study is to prospectively identify the prodromal stage of bipolar disorder
Another primary objective is to conduct a randomized place-controlled trial of aerobic exercise on people who suffering from prodromal symptoms to the extent of significantly impaired function with attempt at delaying or preventing the onset of a full-blown bipolar disorder
Design of study and the procedures
The study will consist of two phases one-week screening period and a randomized placebo-controlled 3-month trial During the screening period offspring of parents with bipolar disorder will undergo systematically clinical evaluations The offspring will be evaluated with clinical symptoms assessing scales neuropsychological tests magnetic resonance imaging During the 3-month trial period the offspring who meet the inclusion criteria will be randomly assigned to receive treatment of aerobic exercise placebo or wait-list group Psychiatrists are scheduled to assess mood treatment outcome during the 3-month trial
Subjects and treatment It is expected that 120 offspring of parents with bipolar disorder aged between 10-25 years meeting the inclusion of prodromal stage will be included in the study All of the offspring will undertake the Kiddie Sads Present and Lifetime Version K-SADS-PL and a 70 checklist items of potential prodromal symptoms suggest by us as well as by Dr Correll et al 2007 The parents of these offspring are to have a DSM-IV Diagnostic and Statistical Manual of Mental Disorders-defined bipolar disorder bipolar I or II confirmed by the Chinese version of Structured Clinical interview for DSM-IV-TR Axis I Disorders patient edition SCID-IP First et al 2002 The offspring are to be recruited through the referrals by their parents who will receive psychiatric services in the Guangzhou psychiatric Hospital
The offspring will be randomly assigned to aerobic exercise and placebo controlled groups The aerobic exercise would include cycling joggingtable tennis and playing badminton for 40 mins at least 3 times a week for 3 months In each exercise participants are supposed to exercise to the extent of getting sweaty In the placebo group participants will receive general psychoeducation including delivering knowledge on symptoms discussion of the suffering mental difficulties and general coping techniques
Significance
Bipolar disorder is a common chronic and recurrent mental disorder The recognition of prodromal stage of bipolar disorder and the early intervention on it may help delay or prevent the onset of bipolar disorder
Detailed Description:
Background and study hypothesis
Bipolar disorder is one of the most common recurrent mental illnesses with a lifetime prevalence of 39 causing physical as well as mental disabilities Nearly 40 of people with bipolar disorder experience at least one attempt of suicide and around 10 end up with suicide completed The mean age of onset for bipolar disorder is 20 years old and the peak age of onset is between 15 and 19 years Evidence shows that the first symptom could present in child as early as 3 years old however getting a proper diagnosis and treatment for bipolar disorder is delayed for 163 years in those presenting the first psychiatric symptom between 3-15 years and for 99 years in those presenting the first psychiatric symptom between 16-25 years Such a delay compromises largely the treatment as well as functional outcome of bipolar disorders
Many studies including prospective studies have been demonstrated that a long symptomatic prodromal phase exists prior to the onset of full-brown bipolar disorder lasting for 9-12 years During the prodromal stage there are three main clusters of syndromes including hypomaniamania symptoms depressive symptoms and signs of attention deficit hyperactivity disorders Of the hypomaniamania symptoms decreased sleep elevated mood irritability mood lability increased energy and psychomotor agitation are present most frequently The prodromal depressive symptoms are reported to be depressed mood anhedonia insomnia feelings of worthlessness Among patients with bipolar disorders 225 reported to comorbid with pediatric ADHD In addition some symptoms are considered as non-specific such as decreased functioning anger outburst social isolation and anxiety
Offspring of parents with bipolar disorders are much likely to present prodromal symptoms compared to offspring of healthy parents In a 10-year longitudinal study using 55 prodromal symptoms checklist Egeland et al found that 38 offspring of parents with bipolar disorder were considered as at risk compared to 17 in children of healthy parents In a 15-year follow-up study Duffy et al found that 327 offspring aged 8-25 years old of parents with bipolar disorder met the criteria of major mood episode
Objectives
One primary objective of this study is to prospectively identify the prodromal stage of bipolar disorder
Another primary objective is to conduct a randomized place-controlled trial of aerobic exercise on people who suffering from prodromal symptoms to the extent of significantly impaired function with attempt at delaying or preventing the onset of a full-blown bipolar disorder
Design of study and the procedures
The study will consist of two phases one-week screening period and a randomized placebo-controlled 3-month trial During the screening period offspring of parents with bipolar disorder will undergo systematically clinical evaluations The offspring will be evaluated with clinical symptoms assessing scales neuropsychological tests magnetic resonance imaging During the 3-month trial period the offspring who meet the inclusion criteria will be randomly assigned to receive treatment of aerobic exercise placebo or wait-list group Psychiatrists are scheduled to assess mood and treatment outcome during the 3-month trial
Subjects and treatment
It is expected that 120 offspring of parents with bipolar disorder aged between 10-25 years meeting the inclusion of prodromal stage will be included in the study All of the offspring will undertake the Kiddie Sads Present and Lifetime Version K-SADS-PL and a 70 checklist items of potential prodromal symptoms suggested by us as well as by Dr Correll and his colleagues The parents of these offspring are to have a DSM-IV Diagnostic and Statistical Manual of Mental Disorders-defined bipolar disorder bipolar I or II confirmed by the Chinese version of Structured Clinical interview for DSM-IV-TR Axis I Disorders patient edition SCID-IP The offspring are to be recruited through the referrals by their parents who will receive psychiatric services in the Guangzhou psychiatric Hospital
The offspring will be randomly assigned to aerobic exercise and placebo controlled group The aerobic exercise would include cycling jogging table tennisand playing badminton for 40 mins at least 3 times a week for 3 months In each exercise participants are supposed to exercise to the extent of getting sweaty In the placebo group participants will receive general psychoeducation including delivering knowledge on symptoms discussion of suffering mental difficulties and general coping techniques
Significance
Bipolar disorder is a common chronic and recurrent mental disorder The recognition of prodromal stage of bipolar disorder and the early intervention on it may help delay or prevent the onset of bipolar disorder
Bipolar disorder is one of the most common recurrent mental illnesses with a lifetime prevalence of 39 causing physical as well as mental disabilities Nearly 40 of people with bipolar disorder experience at least one attempt of suicide and around 10 end up with suicide completed The mean age of onset for bipolar disorder is 20 years old and the peak age of onset is between 15 and 19 years Evidence shows that the first symptom could present in child as early as 3 years old however getting a proper diagnosis and treatment for bipolar disorder is delayed for 163 years in those presenting the first psychiatric symptom between 3-15 years and for 99 years in those presenting the first psychiatric symptom between 16-25 years Such a delay compromises largely the treatment as well as functional outcome of bipolar disorders
Many studies including prospective studies have been demonstrated that a long symptomatic prodromal phase exists prior to the onset of full-brown bipolar disorder lasting for 9-12 years During the prodromal stage there are three main clusters of syndromes including hypomaniamania symptoms depressive symptoms and signs of attention deficit hyperactivity disorders Of the hypomaniamania symptoms decreased sleep elevated mood irritability mood lability increased energy and psychomotor agitation are present most frequently The prodromal depressive symptoms are reported to be depressed mood anhedonia insomnia feelings of worthlessness Among patients with bipolar disorders 225 reported to comorbid with pediatric ADHD In addition some symptoms are considered as non-specific such as decreased functioning anger outburst social isolation and anxiety
Offspring of parents with bipolar disorders are much likely to present prodromal symptoms compared to offspring of healthy parents In a 10-year longitudinal study using 55 prodromal symptoms checklist Egeland et al found that 38 offspring of parents with bipolar disorder were considered as at risk compared to 17 in children of healthy parents In a 15-year follow-up study Duffy et al found that 327 offspring aged 8-25 years old of parents with bipolar disorder met the criteria of major mood episode
Objectives
One primary objective of this study is to prospectively identify the prodromal stage of bipolar disorder
Another primary objective is to conduct a randomized place-controlled trial of aerobic exercise on people who suffering from prodromal symptoms to the extent of significantly impaired function with attempt at delaying or preventing the onset of a full-blown bipolar disorder
Design of study and the procedures
The study will consist of two phases one-week screening period and a randomized placebo-controlled 3-month trial During the screening period offspring of parents with bipolar disorder will undergo systematically clinical evaluations The offspring will be evaluated with clinical symptoms assessing scales neuropsychological tests magnetic resonance imaging During the 3-month trial period the offspring who meet the inclusion criteria will be randomly assigned to receive treatment of aerobic exercise placebo or wait-list group Psychiatrists are scheduled to assess mood and treatment outcome during the 3-month trial
Subjects and treatment
It is expected that 120 offspring of parents with bipolar disorder aged between 10-25 years meeting the inclusion of prodromal stage will be included in the study All of the offspring will undertake the Kiddie Sads Present and Lifetime Version K-SADS-PL and a 70 checklist items of potential prodromal symptoms suggested by us as well as by Dr Correll and his colleagues The parents of these offspring are to have a DSM-IV Diagnostic and Statistical Manual of Mental Disorders-defined bipolar disorder bipolar I or II confirmed by the Chinese version of Structured Clinical interview for DSM-IV-TR Axis I Disorders patient edition SCID-IP The offspring are to be recruited through the referrals by their parents who will receive psychiatric services in the Guangzhou psychiatric Hospital
The offspring will be randomly assigned to aerobic exercise and placebo controlled group The aerobic exercise would include cycling jogging table tennisand playing badminton for 40 mins at least 3 times a week for 3 months In each exercise participants are supposed to exercise to the extent of getting sweaty In the placebo group participants will receive general psychoeducation including delivering knowledge on symptoms discussion of suffering mental difficulties and general coping techniques
Significance
Bipolar disorder is a common chronic and recurrent mental disorder The recognition of prodromal stage of bipolar disorder and the early intervention on it may help delay or prevent the onset of bipolar disorder
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2011B031800154 | OTHER_GRANT | Guangdong Science and technology Department | None |