Clinical Trial: Recognition and Early Intervention on Prodrome in Bipolar Disorders

Study Status: Completed
Recruit Status: Unknown status
Study Type: Interventional

Official Title: Recognition and Early Intervention on Prodrome in Bipolar Disorders: a Longitudinal Prospective Study of the Offspring of Parents With Bipolar Disorder

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

Detailed Summary:

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
Sponsor: Guangzhou Psychiatric Hospital

Current 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

Original Primary Outcome: Change from Baseline in Clinical Global Impressions (CGI) Scale at 12 weeks [ Time Frame: Baseline and 12 weeks ]

Current Secondary Outcome:

• 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

Original Secondary Outcome:

• 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
• Treatment Emergent Symptom Scale [ Time Frame: 12 weeks ]
  Treatment Emergent Symptom Scale is used to assess the adverse event of the drug.

Dates:
Date Received: May 21, 2013
Date Started: March 2013
Date Completion: December 2015
Last Updated: March 14, 2015
Last Verified: March 2015