Recognition and Early Intervention on Prodrome in Bipolar Disorders
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| ClinicalTrials.gov Identifier: NCT01863628 |
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Recruitment Status : Unknown
Verified March 2015 by Guiyun Xu, Guangzhou Psychiatric Hospital.
Recruitment status was: Recruiting
First Posted : May 29, 2013
Last Update Posted : March 17, 2015
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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.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Bipolar Disorder | Other: aerobic exercise Other: psychoeducation | Not Applicable |
Show detailed description
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 120 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Double (Investigator, Outcomes Assessor) |
| Primary Purpose: | Prevention |
| Official Title: | Recognition and Early Intervention on Prodrome in Bipolar Disorders: a Longitudinal Prospective Study of the Offspring of Parents With Bipolar Disorder |
| Study Start Date : | March 2013 |
| Estimated Primary Completion Date : | December 2015 |
| Estimated Study Completion Date : | December 2015 |
| Arm | Intervention/treatment |
|---|---|
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Placebo Comparator: psychoeducation
including delivering knowledge on symptoms, discussion of suffering mental difficulties, and general coping techniques
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Other: psychoeducation |
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Experimental: aerobic exercise
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
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Other: aerobic exercise |
- 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
- Change from Baseline in Hamilton Depression Rating Scale at 12 weeks [ Time Frame: baseline and after 12 weeks ]Hamilton Depression Rating Scale is used to assess the depressive symptoms.
- Change from baseline in Young Mania Rating Scale at 12 weeks [ Time Frame: baseline and 12 weeks ]Young Mania Rating Scale is used to assess hypomania/mania symptoms
- Change from baseline in Brief Psychiatric Rating Scale at 12 weeks [ Time Frame: baseline and 12 weeks ]Brief Psychiatric Rating Scale is used to assess psychotic symptoms.
- Change from baseline in Hamilton Anxiety Rating Scale at 12 weeks [ Time Frame: baseline and 12 weeks ]Hamilton Anxiety Rating Scale is used to assess anxious symptoms
- Change from baseline in Global Assessment Scale at 12 weeks [ Time Frame: baseline and 12 weeks ]Global Assessment Scale is a numeric scale (1 through 100) used by mental health clinicians to rate the general functioning of children
- Neuropsychological performance [ Time Frame: baseline and 12 weeks ]
Neuropsychological performance is valuated with the MATRICS Consensus Cognitive Battery (MCCB), Test of Nonverbal Intelligence, Third Edition (TONI-3), and STROOP task.
The MATRICS Consensus Cognitive Battery (MCCB), developed by the National Institute of Mental Health (NIMH) Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS) initiative, has been recommended as the standard battery for clinical trials of cognition-enhancing interventions for schizophrenia as well as bipolar disorders.
TONI-3 is used as language free intelligence measure which also helps in the assessment of aptitude, abstract reasoning and problem solving.
- Functional magnetic resonance imaging [ Time Frame: baseline and 12 weeks ]Functional magnetic resonance imaging or functional MRI (fMRI) is an magnetic resonance imaging procedure that measures brain activity by detecting associated changes in blood flow.
- 70 prodromal symptoms checklist for bipolar disorder [ Time Frame: baseline ]The instrument consists of 70 items assessing different sorts of symptoms, based on the researchers' clinical experiences and the current literature.
- 70 prodromal symptoms checklist for bipolar disorder [ Time Frame: 12 weeks ]The instrument consists of 70 items assessing different sorts of symptoms, based on the researchers' clinical experiences and the current literature.
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| Ages Eligible for Study: | 10 Years to 25 Years (Child, Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01863628
| Contact: Guiyun Xu, MD | 86(02081891425) ext 8111 | xuguiyun2908@hotmail.com |
| China, Guangdong | |
| Guangzhou Psychiatric Hospital | Enrolling by invitation |
| Guangzhou, Guangdong, China, 510370 | |
| Guangzhou psychiatric Hospital | Recruiting |
| Guangzhou, Guangdong, China, 510370 | |
| Contact: Guiyun Xu, M.D 8618922165291 xuguiyun2908@hotmail.com | |
| Principal Investigator: Kangguang Lin, M.D | |
| Principal Investigator: Guiyun Xu, MD | |
| Study Director: | Guiyun Xu, M.D | Guangzhou Psychiatric Hospital | |
| Principal Investigator: | Kangguang Lin, M.D | The University of Hong Kong |
Publications:
| Responsible Party: | Guiyun Xu, Associate Professor, Guangzhou Psychiatric Hospital |
| ClinicalTrials.gov Identifier: | NCT01863628 |
| Other Study ID Numbers: |
20120508 2011B031800154 ( Other Grant/Funding Number: Guangdong Science and technology Department ) |
| First Posted: | May 29, 2013 Key Record Dates |
| Last Update Posted: | March 17, 2015 |
| Last Verified: | March 2015 |
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Prodromal Symptoms bipolar disorder Neuropsychological Tests Magnetic Resonance Imaging |
Treatment Outcome aerobic exercise psychotherapy |
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Disease Bipolar Disorder Pathologic Processes Bipolar and Related Disorders Mental Disorders |