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Trial record 7 of 31 for:    prodrome

Recognition and Early Intervention on Prodrome in Bipolar Disorders

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ClinicalTrials.gov Identifier: NCT01863628
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
Sponsor:
Collaborator:
The University of Hong Kong
Information provided by (Responsible Party):
Guiyun Xu, Guangzhou Psychiatric Hospital

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 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

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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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Placebo Comparator: psychoeducation
including delivering knowledge on symptoms, discussion of suffering mental difficulties, and general coping techniques
Other: psychoeducation
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
Other: aerobic exercise



Primary Outcome Measures :
  1. 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

  2. Diagnostic status [ Time Frame: baseline and 3 months after treatment ]
    to access whether participants are in the defined prodromal stage of bipolar disorder


Secondary Outcome Measures :
  1. 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.

  2. 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

  3. 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.

  4. 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

  5. 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


Other Outcome Measures:
  1. 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.


  2. 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.

  3. 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.

  4. 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
Criteria

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

Information from the National Library of Medicine

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


Contacts
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Contact: Guiyun Xu, MD 86(02081891425) ext 8111 xuguiyun2908@hotmail.com

Locations
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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         
Sponsors and Collaborators
Guangzhou Psychiatric Hospital
The University of Hong Kong
Investigators
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Study Director: Guiyun Xu, M.D Guangzhou Psychiatric Hospital
Principal Investigator: Kangguang Lin, M.D The University of Hong Kong
Additional Information:
Publications:
First 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.

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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
Keywords provided by Guiyun Xu, Guangzhou Psychiatric Hospital:
Prodromal Symptoms
bipolar disorder
Neuropsychological Tests
Magnetic Resonance Imaging
Treatment Outcome
aerobic exercise
psychotherapy
Additional relevant MeSH terms:
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Disease
Bipolar Disorder
Pathologic Processes
Bipolar and Related Disorders
Mental Disorders