Bipolar DisorderNCT01863628
Recognition and Early Intervention on Prodrome in Bipolar Disorders
A study testing aerobic exercise and psychoeducation in people with Bipolar Disorder, run by Guangzhou Psychiatric Hospital at 2 sites in China.
Trial 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). Read more about this study
- Who is it for?
- Ages 10 to 25 years
- Conditions the study is for
- Bipolar Disorder
- What is being tested?
- aerobic exercise and psychoeducation
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- 2 sitesChina
- Study dates
- Mar 2013to Dec 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 10 to 25 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- have at least one biological parent diagnosed as bipolar disorder (bipolar I or II)
- have at least one of the following syndromes i) two or more DSM-IV defined hypomania/mania symptoms, lasting for at least 4 days; ii) two or more DSM defined major depressive symptoms, lasting for 1 week; iii) at least one of the psychotic symptoms, lasting at least 10 min for each manifestation, and 2-7 manifestations a week for at least 3 months, including: ideas of reference; odd ideas, odd belief, unusual perceptual experiences, bizarre thought or speech, Grandiosity, suspicious ideas, paranoid idea, odd mannerisms, hallucination, disorganized/catatonic behavior; iv)two or more of the DSM-IV defined Attention deficit hyperactivity disorder (ADHD)symptoms; and there must be clear evidence of clinically significant impairment in social, academic, or occupational functioning due to ADHD symptoms
Who cannot join
- DSM-IV defined Axis I disorders;
- Serious general medical illness;
- mental retardation;
- was/is treated with antipsychotic drugs;
- unable to complete neuropsychological tests due to physical conditions;
- in pregnancy and lactation;
- was taking thyroxine therapy in the last three months or is taking hormone therapy
Trial locations and contacts
2 sites in 1 country.
China2 sites, 2 recruiting
- Enrolling by invitation
Guangzhou Psychiatric Hospital
Guangzhou, Guangdong, 510370
- Recruiting
Guangzhou psychiatric Hospital
Guangzhou, Guangdong, 510370
Guiyun Xu, M.D, 8618922165291, xuguiyun2908@hotmail.com
Kangguang Lin, M.D
About this study
Official title: Recognition and Early Intervention on Prodrome in Bipolar Disorders: a Longitudinal Prospective Study of the Offspring of Parents With Bipolar Disorder
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 hypomania/mania symptoms, depressive symptoms, and signs of attention deficit hyperactivity disorders (Correll et al., 2007; Tillman et al., 2003; Mantere et al., 2008). Of the hypomania/mania 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, 22.5% 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).
Read more
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.(2002) 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.,(2009) found that 32.7% 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-I/P) [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, jogging,table 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.
Read the detailed description
Background and study hypothesis:
Bipolar disorder is one of the most common recurrent mental illnesses, with a lifetime prevalence of 3.9%, 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 16.3 years in those presenting the first psychiatric symptom between 3-15 years, and for 9.9 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 hypomania/mania symptoms, depressive symptoms, and signs of attention deficit hyperactivity disorders. Of the hypomania/mania 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, 22.5% 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 32.7% 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-I/P). 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 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 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.
- Conditions
- Bipolar Disorder
- Being tested
- aerobic exercise, psychoeducation
- Keywords
- Prodromal Symptoms, bipolar disorder, Neuropsychological Tests, Magnetic Resonance Imaging, Treatment Outcome, aerobic exercise, psychotherapy
- Medical subject headings
- Bipolar Disorder, Prodromal Symptoms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
aerobic exerciseOther
psychoeducationOther
| Study group | Role | What they receive |
|---|---|---|
| psychoeducation | Placebo comparator | including delivering knowledge on symptoms, discussion of suffering mental difficulties, and general coping techniques Receives: Other: psychoeducation |
| aerobic exercise | Experimental | The aerobic exercise would include cycling, jogging, table tennis,and playing badminton for 40 mins at least 3 times per week for 3 months. In each exercise, participants are supposed to exercise to the extent of getting sweaty Receives: Other: aerobic exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline in Clinical Global Impressions (CGI) Scale at 12 weeks
Clinical Global Impressions (CGI) Scale is used to assess the patient's global functioning prior to and after initiating a study medication. The CGI provides an overall clinician-determined summary measure, taking into account all available information, including a knowledge of the patient's history, psychosocial circumstances, symptoms, behavior, and the impact of the symptoms on the patient's ability to function
Measured: Baseline and 12 weeks
Diagnostic status
to access whether participants are in the defined prodromal stage of bipolar disorder
Measured: baseline and 3 months after treatment
Secondary outcomes (5)
Change from Baseline in Hamilton Depression Rating Scale at 12 weeks
Hamilton Depression Rating Scale is used to assess the depressive symptoms.
Measured: baseline and after 12 weeks
Change from baseline in Young Mania Rating Scale at 12 weeks
Young Mania Rating Scale is used to assess hypomania/mania symptoms
Measured: baseline and 12 weeks
Change from baseline in Brief Psychiatric Rating Scale at 12 weeks
Brief Psychiatric Rating Scale is used to assess psychotic symptoms.
Measured: baseline and 12 weeks
Change from baseline in Hamilton Anxiety Rating Scale at 12 weeks
Hamilton Anxiety Rating Scale is used to assess anxious symptoms
Measured: baseline and 12 weeks
Change from baseline in Global Assessment Scale at 12 weeks
Global Assessment Scale is a numeric scale (1 through 100) used by mental health clinicians to rate the general functioning of children
Measured: baseline and 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 May 2013 (estimated)
- Study startMar 2013
- Primary completionDec 2015 (estimated)
- Study completionDec 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (12)Papers the sponsor has linked to this study.
- Other trials for Bipolar DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Guangzhou Psychiatric Hospital
- Sponsor type
- Other government
- Collaborators
- The University of Hong Kong
- Responsible party
- Principal investigator, Guiyun Xu, Guangzhou Psychiatric Hospital
- Investigators
- Guiyun Xu, M.D, Study director, Guangzhou Psychiatric HospitalKangguang Lin, M.D, Principal investigator, The University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01863628
- Sponsor's protocol ID
- 20120508
- Other IDs
- 2011B031800154
- Status last verified
- Mar 2015
- First submitted
- 21 May 2013
- Last updated
- 17 Mar 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Berk M, Dodd S, Callaly P, Berk L, Fitzgerald P, de Castella AR, Filia S, Filia K, Tahtalian S, Biffin F, Kelin K, Smith M, Montgomery W, Kulkarni J. History of illness prior to a diagnosis of bipolar disorder or schizoaffective disorder. J Affect Disord. 2007 Nov;103(1-3):181-6. doi: 10.1016/j.jad.2007.01.027. Epub 2007 Feb 26.
PubMed 17324469Correll CU, Penzner JB, Frederickson AM, Richter JJ, Auther AM, Smith CW, Kane JM, Cornblatt BA. Differentiation in the preonset phases of schizophrenia and mood disorders: evidence in support of a bipolar mania prodrome. Schizophr Bull. 2007 May;33(3):703-14. doi: 10.1093/schbul/sbm028. Epub 2007 May 2.
PubMed 17478437Duffy A, Alda M, Hajek T, Grof P. Early course of bipolar disorder in high-risk offspring: prospective study. Br J Psychiatry. 2009 Nov;195(5):457-8. doi: 10.1192/bjp.bp.108.062810.
PubMed 19880938Dutta R, Boydell J, Kennedy N, VAN Os J, Fearon P, Murray RM. Suicide and other causes of mortality in bipolar disorder: a longitudinal study. Psychol Med. 2007 Jun;37(6):839-47. doi: 10.1017/S0033291707000347. Epub 2007 Mar 12.
PubMed 17349107Druss BG, Hwang I, Petukhova M, Sampson NA, Wang PS, Kessler RC. Impairment in role functioning in mental and chronic medical disorders in the United States: results from the National Comorbidity Survey Replication. Mol Psychiatry. 2009 Jul;14(7):728-37. doi: 10.1038/mp.2008.13. Epub 2008 Feb 19.
PubMed 18283278Egeland JA, Hostetter AM, Pauls DL, Sussex JN. Prodromal symptoms before onset of manic-depressive disorder suggested by first hospital admission histories. J Am Acad Child Adolesc Psychiatry. 2000 Oct;39(10):1245-52. doi: 10.1097/00004583-200010000-00011.
PubMed 11026178Egeland JA, Shaw JA, Endicott J, Pauls DL, Allen CR, Hostetter AM, Sussex JN. Prospective study of prodromal features for bipolarity in well Amish children. J Am Acad Child Adolesc Psychiatry. 2003 Jul;42(7):786-96. doi: 10.1097/01.CHI.0000046878.27264.12.
PubMed 12819438Tillman R, Geller B, Bolhofner K, Craney JL, Williams M, Zimerman B. Ages of onset and rates of syndromal and subsyndromal comorbid DSM-IV diagnoses in a prepubertal and early adolescent bipolar disorder phenotype. J Am Acad Child Adolesc Psychiatry. 2003 Dec;42(12):1486-93. doi: 10.1097/00004583-200312000-00016.
PubMed 14627884Hauser M, Pfennig A, Ozgurdal S, Heinz A, Bauer M, Juckel G. Early recognition of bipolar disorder. Eur Psychiatry. 2007 Mar;22(2):92-8. doi: 10.1016/j.eurpsy.2006.08.003. Epub 2006 Dec 4.
PubMed 17142013Kessler RC, Berglund P, Demler O, Jin R, Merikangas KR, Walters EE. Lifetime prevalence and age-of-onset distributions of DSM-IV disorders in the National Comorbidity Survey Replication. Arch Gen Psychiatry. 2005 Jun;62(6):593-602. doi: 10.1001/archpsyc.62.6.593.
PubMed 15939837Mantere O, Suominen K, Valtonen HM, Arvilommi P, Isometsa E. Only half of bipolar I and II patients report prodromal symptoms. J Affect Disord. 2008 Dec;111(2-3):366-71. doi: 10.1016/j.jad.2008.03.011. Epub 2008 Apr 28.
PubMed 18442858First MB, Spitzer RL, Gibbon M, Williams JBW. Structured Clinical Interview for DSM-IV-TR Axis I Disorders-Patient Edition (SCID-I/P, 11/2002 Revision). Biometrics Research Department, New York State Psychiatric Institute, New York.2002.
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Recognition and Early Intervention on Prodrome in Bipolar Disorders: a Longitudinal Prospective Study of the Offspring of Parents With Bipolar Disorder
- ClinicalTrials.gov ID
- NCT01863628
- Acronym / sponsor ID
- 20120508
- Conditions
- Bipolar Disorder
- Keywords
- Prodromal Symptoms, bipolar disorder, Neuropsychological Tests, Magnetic Resonance Imaging, Treatment Outcome, aerobic exercise, psychotherapy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Guangzhou Psychiatric HospitalOther government
- Collaborators
- The University of Hong Kong
- Study start
- Mar 2013
- Primary completion
- Dec 2015 (estimated)
- Study completion
- Dec 2015 (estimated)
- First posted
- 29 May 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 hypomania/mania symptoms, depressive symptoms, and signs of attention deficit hyperactivity disorders (Correll et al., 2007; Tillman et al., 2003; Mantere et al., 2008). Of the hypomania/mania 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, 22.5% 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 al.(2002) 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.,(2009) found that 32.7% 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-I/P) [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, jogging,table 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 3.9%, 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 16.3 years in those presenting the first psychiatric symptom between 3-15 years, and for 9.9 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 hypomania/mania symptoms, depressive symptoms, and signs of attention deficit hyperactivity disorders. Of the hypomania/mania 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, 22.5% 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 32.7% 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-I/P). 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 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 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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| psychoeducation | Placebo comparator | Other: psychoeducationincluding delivering knowledge on symptoms, discussion of suffering mental difficulties, and general coping techniques |
| aerobic exercise | Experimental | Other: aerobic exerciseThe aerobic exercise would include cycling, jogging, table tennis,and playing badminton for 40 mins at least 3 times per week for 3 months. In each exercise, participants are supposed to exercise to the extent of getting sweaty |
Who may qualify
- Ages
- 10 to 25 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- have at least one biological parent diagnosed as bipolar disorder (bipolar I or II)
- have at least one of the following syndromes i) two or more DSM-IV defined hypomania/mania symptoms, lasting for at least 4 days; ii) two or more DSM defined major depressive symptoms, lasting for 1 week; iii) at least one of the psychotic symptoms, lasting at least 10 min for each manifestation, and 2-7 manifestations a week for at least 3 months, including: ideas of reference; odd ideas, odd belief, unusual perceptual experiences, bizarre thought or speech, Grandiosity, suspicious ideas, paranoid idea, odd mannerisms, hallucination, disorganized/catatonic behavior; iv)two or more of the DSM-IV defined Attention deficit hyperactivity disorder (ADHD)symptoms; and there must be clear evidence of clinically significant impairment in social, academic, or occupational functioning due to ADHD symptoms
Key exclusion criteria (7 listed)
- DSM-IV defined Axis I disorders;
- Serious general medical illness;
- mental retardation;
- was/is treated with antipsychotic drugs;
- unable to complete neuropsychological tests due to physical conditions;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| aerobic exercise | Other | aerobic exercise |
| psychoeducation | Other | psychoeducation |
Primary outcome
Change from Baseline in Clinical Global Impressions (CGI) Scale at 12 weeks
Time frame: Baseline and 12 weeks
Clinical Global Impressions (CGI) Scale is used to assess the patient's global functioning prior to and after initiating a study medication. The CGI provides an overall clinician-determined summary measure, taking into account all available information, including a knowledge of the patient's history, psychosocial circumstances, symptoms, behavior, and the impact of the symptoms on the patient's ability to function
Diagnostic status
Time frame: baseline and 3 months after treatment
to access whether participants are in the defined prodromal stage of bipolar disorder
5 secondary outcomes
Change from Baseline in Hamilton Depression Rating Scale at 12 weeks
Time frame: baseline and after 12 weeks
Change from baseline in Young Mania Rating Scale at 12 weeks
Time frame: baseline and 12 weeks
Change from baseline in Brief Psychiatric Rating Scale at 12 weeks
Time frame: baseline and 12 weeks
Change from baseline in Hamilton Anxiety Rating Scale at 12 weeks
Time frame: baseline and 12 weeks
Change from baseline in Global Assessment Scale at 12 weeks
Time frame: baseline and 12 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Mar 2015.
- Background: PubMed 17324469Berk M, Dodd S, Callaly P, Berk L, Fitzgerald P, de Castella AR, Filia S, Filia K, Tahtalian S, Biffin F, Kelin K, Smith M, Montgomery W, Kulkarni J. History of illness prior to a diagnosis of bipolar disorder or schizoaffective disorder. J Affect Disord. 2007 Nov;103(1-3):181-6. doi: 10.1016/j.jad.2007.01.027. Epub 2007 Feb 26.
- Background: PubMed 17478437Correll CU, Penzner JB, Frederickson AM, Richter JJ, Auther AM, Smith CW, Kane JM, Cornblatt BA. Differentiation in the preonset phases of schizophrenia and mood disorders: evidence in support of a bipolar mania prodrome. Schizophr Bull. 2007 May;33(3):703-14. doi: 10.1093/schbul/sbm028. Epub 2007 May 2.
- Background: PubMed 19880938Duffy A, Alda M, Hajek T, Grof P. Early course of bipolar disorder in high-risk offspring: prospective study. Br J Psychiatry. 2009 Nov;195(5):457-8. doi: 10.1192/bjp.bp.108.062810.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Guiyun Xu, M.D study director
Guangzhou Psychiatric Hospital
Kangguang Lin, M.D principal investigator
The University of Hong Kong
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing aerobic exercise and psychoeducation in people with Bipolar Disorder, run by Guangzhou Psychiatric Hospital at 2 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 17 Mar 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Guiyun Xu, MD (86(02081891425) ext. 8111, xuguiyun2908@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from Baseline in Clinical Global Impressions (CGI) Scale at 12 weeks (time frame: Baseline and 12 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01863628, which also lists 12 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Mar 2015.